The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index; 4 of the 10 sources its claims cite were checked for support.
Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.
Open accessAbstract
BACKGROUND: Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and refractory multiple myeloma. METHODS: CAR-positive (CAR+) T cells. The primary end point was an overall response (partial response or better); a key secondary end point was a complete response or better (comprising complete and stringent complete responses). RESULTS: nucleated cells) was confirmed in 33 patients, representing 26% of all 128 patients who were treated and 79% of the 42 patients who had a complete response or better. The median progression-free survival was 8.8 months (95% confidence interval, 5.6 to 11.6). Common toxic effects among the 128 treated patients included neutropenia in 117 patients (91%), anemia in 89 (70%), and thrombocytopenia in 81 (63%). Cytokine release syndrome was reported in 107 patients (84%), including 7 (5%) who had events of grade 3 or higher. Neurotoxic effects developed in 23 patients (18%) and were of grade 3 in 4 patients (3%); no neurotoxic effects higher than grade 3 occurred. Cellular kinetic analysis confirmed CAR+ T cells in 29 of 49 patients (59%) at 6 months and 4 of 11 patients (36%) at 12 months after infusion. CONCLUSIONS: Ide-cel induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma; MRD-negative status was achieved in 26% of treated patients. Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome. (Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company; KarMMa ClinicalTrials.gov number, NCT03361748.).
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Claims the paper makes
79 Own result · 10 Own method · 8 Own interpretation · 4 Sources not found · 2 Partly supported · 2 No basis given · 1 Supported · 1 Supported so far · accuracy not yet measured
Every source the paper cites for this claim was checked and supports it.
In the paper
“The B-cell maturation antigen (BCMA)-directed CAR T cell idecabtagene vicleucel (ide-cel, also called bb2121) showed promising efficacy in a phase 1 study involving patients with relapsed or refractory myeloma.11”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > D
What the sources say
- Supportedcites [11] 11. Raje N, Berdeja J, Lin Y, et al. Anti- BCMA CAR T-cell therapy bb2121 in re- lapsed or refractory multiple myeloma. N Engl J Med 2019; 380: 1726-37. source
The Methods identify bb2121 as an anti-BCMA CAR T-cell therapy studied in a phase 1 trial involving patients with relapsed or refractory multiple myeloma. The Discussion reports an 85% clinical response rate, supporting the characterization of its efficacy as promising. (LLM, conf=0.94)
plaincorrelational- Asserted: passes — The authors put it forward as true.
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- Supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“These efficacy results compare favorably with results in similarly heavily pretreated patients with relapsed or refractory myeloma treated with two recently approved regimens, selinexor plus dexamethasone and belantamab mafodotin (median progression-free survival, 3.7 months and 2.9 months, respectively).5,17”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
What the sources say
- Supportedcites [5] 5. Chari A, Vogl DT, Gavriatopoulou M, et al. Oral selinexor-dexamethasone for triple-class refractory multiple myeloma. N Engl J Med 2019; 381: 727-38. source
The Methods and Discussion describe patients with triple-class refractory myeloma who were heavily pretreated, with a median of seven previous regimens. The Efficacy section reports median progression-free survival of 3.7 months with selinexor plus dexamethasone. This citation supports the selinexor result; the separate belantamab result is not attributed to this paper. (LLM, conf=0.92)
- Not checked — no full text of the sourcecites [17] 17. Lonial S, Lee HC, Badros A, et al. Belan- tamab mafodotin for relapsed or refracto- ry multiple myeloma (DREAMM-2): a two- arm, randomised, open-label, phase 2 study. Lancet Oncol 2020; 21: 207-21. source
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- Rests on an assumption: Cross-trial comparisons of progression-free survival between the KarMMa study and trials of selinexor plus dexamethasone or belantamab mafodotin are valid.
- Supported
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In the paper
“Observed toxic effects were consistent with those in previous reports.11”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
What the sources say
- Partly supportedcites [11] 11. Raje N, Berdeja J, Lin Y, et al. Anti- BCMA CAR T-cell therapy bb2121 in re- lapsed or refractory multiple myeloma. N Engl J Med 2019; 380: 1726-37. sourceExperimental — accuracy not yet measured
The Results (Safety; page unavailable) document the observed toxic effects. The Discussion compares them with previous studies, but reports a lower incidence of severe cytokine release syndrome with bb2121 and cautions that cross-study comparisons are complicated. It does not establish that the toxic effects were generally consistent with previous reports. (LLM, conf=0.82)
plain- Asserted: passes — The authors put it forward as true.
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- Partly supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Duration of undetectable sBCMA correlated with response duration, and clearance of sBCMA at month 2 was associated with longer progression-free survival (Fig. S5E and S5F).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Figure 2 (facing page). Progression-free Survival, Duration of Response, and Overall Survival.
plaincorrelational- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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- Rests on an assumption: Soluble BCMA is a serum-based universal marker of myeloma burden.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“with peak levels higher in patients having cytokine release syndrome of grade 3 or higher (Fig. S6).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Biomarkers
plaincorrelational- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“a somewhat higher frequency and somewhat greater depth of response were observed at the 450 × 10 6 dose (response in 81% of the pa-tients and complete response or better in 39%).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
plain- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At baseline, 110 of 112 tumor samples (98%) expressed BCMA, with 109 having at least 50% BCMA-positive plasma cells, and all the patients had detectable levels of sBCMA.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Figure 2 (facing page). Progression-free Survival, Duration of Response, and Overall Survival.
plainn = 112- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A response was observed in 73% of the treated patients, and a complete response or better was observed in 33%;”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“Baseline cytokine levels were not associated with higher-grade cytokine release syndrome or neurotoxic effects.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Biomarkers
plain- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“with an incidence of response to bridging therapy of 4%”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
plain- Asserted: passes — The authors put it forward as true.
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- Probably not a substantial claim. 12
- It may state two separate claims as one. 32
- The quote only partly states this claim. 1
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In contrast, CD19 epitope loss is reported to be a relatively common escape mechanism after treatment with CD19-directed CAR T-cell therapy, especially in patients with acute leukemia.18,19”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
What the sources say
- Partly supportedcites [18] 18. Cheng J, Zhao L, Zhang Y, et al. Un- derstanding the mechanisms of resis- tance to CAR T-cell therapy in malignan- cies. Front Oncol 2019; 9: 1237. sourceExperimental — accuracy not yet measured
The Tumor Factors section reports that loss of the targeted CD19 epitope enabled escape after anti-CD19 CAR T-cell therapy in relapsed B-ALL. It also reports that target-antigen-negative relapse accounts for approximately 9–25% of B-ALL relapses, but does not establish that epitope loss specifically is relatively common or more common in acute leukemia than in other malignancies. (LLM, conf=0.82)
- Not checked — no full text of the sourcecites [19] 19. Badar T, Shah NN. Chimeric antigen receptor T cell therapy for acute lympho- blastic leukemia. Curr Treat Options On- col 2020; 21: 16. source
plaindirect- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Partly supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among patients with persistent grade 3 or 4 neutropenia (52 patients) or thrombocytopenia (62 patients) 1 month after infusion, the median time to recovery to grade 2 or lower was 1.9 months (range, 1.2 to 5.6) and 2.1 months (range, 1.2 to 13.8), respectively”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Safety
plainn = 52- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
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In the paper
“The Kaplan-Meier estimated median progression-free survival was 8.8 months overall (95% CI, 5.6 to 11.6), 12.1 months (95% CI, 8.8 to 12.3) at the 450 × 10 6 dose, and 20.2 months (95% CI, 12.3 to could not be estimated) in patients having a complete or stringent complete response”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
hedged- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The 128 treated patients had received a median of 6 previous antimyeloma regimens (range, 3 to 16), and 120 (94%) had received previous autologous hematopoietic stem-cell transplants (Table 1).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Patients
plainn = 128- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although high interpatient variability was observed at all doses, upper quartiles of exposure (area under the curve of the transgene level from time of dose to 28 days [AUC 0-28 days ]) were observed more frequently at the 450 × 10 6 dose (Fig. 3B).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Cellular Pharmacokinetic Profile and Immunogenicity
plaincorrelationaln = 127- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among treated patients, 5 were positive for antidrug antibodies before infusion.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Cellular Pharmacokinetic Profile and Immunogenicity
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: fails — The paper’s conclusions may not depend on it.
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Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Baseline sBCMA levels were elevated in treated patients and de-creased rapidly after infusion in patients who had a response, with nadir values achieved within 3 months (Fig. 3A and Fig. S5B and S5C).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Biomarkers
plaincorrelational- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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It may state two separate claims as one.
- Rests on an assumption: Soluble BCMA is a serum-based universal marker of myeloma burden.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Neurotoxic effects developed in 23 patients (18%) and were of grade 3 in 4 patients (3%); no neurotoxic effects higher than grade 3 occurred.”
- Also stated in: § Table 1. (Continued.) · plain
“Investigator-identified neurotoxic effects were reported in 23 patients (18%), of whom 4 (3%) had grade 3 events; no grade 4 or 5 neu-rotoxic effects were observed”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Abstract
plainn = 128- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Also stated in: § Table 1. (Continued.) · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The median time to first response was 1.0 month (range, 0.5 to 8.8); the median time to a complete response or better was 2.8 months (range, 1.0 to 11.8).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
plain- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At doses of 150 × 10 6 , 300 × 10 6 , and 450 × 10 6 CAR+ T cells, neurotoxic effects of any grade were reported in 0 of 4 patients, 12 of 70 patients (17%), and 11 of 54 patients (20%), respectively, with grade 3 events in 0 patients, 1 patient (1%), and 3 patients (6%).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Table 1. (Continued.)
plainn = 54- Asserted: passes — The authors put it forward as true.
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In the paper
“Antidrug antibodies had no effect on the incidence of response or of complete response or better and had no noticeable effect on progression-free survival.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Cellular Pharmacokinetic Profile and Immunogenicity
plain- Asserted: passes — The authors put it forward as true.
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- Rests on an assumption: The absence of a detectable effect of antidrug antibodies on efficacy is not due to insufficient statistical power.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The Kaplan-Meier estimated median overall survival was 19.4 months (95% CI, 18.2 to could not be estimated), with an overall survival of 78% at 12 months (Fig. 2D).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
hedged- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Exposures were higher in patients who had a response than in those who did not (Fig. S5A), and higher exposure was associated with deeper response and longer progression-free survival (Fig. 3C and 3D).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Cellular Pharmacokinetic Profile and Immunogenicity
plaincorrelationaln = 127- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Achievement of undetectable sBCMA levels increased with depth of response (17 of 27 pa-”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Biomarkers
plaincorrelational- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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The quote only partly states this claim.
- Rests on an assumption: Soluble BCMA is a serum-based universal marker of myeloma burden.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At doses of 150 × 10 6 , 300 × 10 6 , and 450 × 10 6 CAR+ T cells, cytokine release syndrome of any grade was observed in 2 of 4 patients (50%), 53 of 70 patients (76%), and 52 of 54 patients (96%), respectively, with cytokine release syndrome of grade 3 or higher observed in 0 patients, 4 patients (6%), and 3 patients (6%).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Table 1. (Continued.)
plaincorrelationaln = 54- Asserted: passes — The authors put it forward as true.
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In the paper
“The Kaplan-Meier estimate for median duration of response was 10.7 months (95% CI, 9.0 to 11.3) overall and 11.3 months (95% CI, 10.3 to 11.4) at the 450 × 10 6 dose”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
hedged- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Cytokine release syndrome was reported in 107 patients (84%), including 7 (5%) who had events of grade 3 or higher.”
- Also stated in: § Table 1. (Continued.) · plain
“Cytokine release syndrome occurred in 107 patients (84%) and was mostly of grade 1 or 2 (Table 2 and Table S10).Five patients (4%) had grade 3 cytokine release syndrome, 1 (<1%) had grade 4, and 1 (<1%) had grade 5 (300 × 10 6 dose level).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Abstract
plainn = 128- Asserted: passes — The authors put it forward as true.
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- Also stated in: § Table 1. (Continued.) · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Infections occurred in 88 patients (69%) and were of grade 3 or 4 in 28 (22%).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Safety
plainn = 88- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“including many with a high tumor burden, high-risk cytogenetic abnormalities, and extramedullary disease.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Common toxic effects among the 128 treated patients included neutropenia in 117 patients (91%), anemia in 89 (70%), and thrombocytopenia in 81 (63%).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Abstract
plainn = 128- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After disease progression, 28 patients were retreated with ide-cel (Table S4).Six patients (21%) had a second response, with durations of response ranging from 1.9 to 6.8 months; all the patients who had a response were retreated at a dose higher than their initial dose.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
plaincorrelationaln = 28- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most grade 3 or 4 events were hematologic toxic effects, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Safety
plainn = 114- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A total of 44 treated patients (34%) died during the study, with most deaths (27) attributed by the investigator to complications of myeloma progression (Table S12).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Table 1. (Continued.)
plainn = 44- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Levels of proinflammatory markers, including cytokines, ferritin, and C-reactive protein, increased early after ide-cel infusion and decreased by month 1”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Biomarkers
plaindirect- Asserted: passes — The authors put it forward as true.
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- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The response duration increased with the depth of response; the median response duration was 4.5 months (95% CI, 2.9 to 6.7), 10.4 months (95% CI, 5.1 to 11.3), and 19.0 months (95% CI, 11.3 to could not be estimated) in patients having a best response of partial response (27 patients), very good partial response (25 patients), and complete or stringent complete response (42 patients),”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At the target doses of 150 × 10 6 , 300 × 10 6 , and 450 × 10 6 CAR+ T cells, a response was observed in 2 of 4 patients (50%), in 48 of 70 patients (69%), and in 44 of 54 patients (81%), respectively, and a complete response or better was observed in 1 of 4 patients (25%), in 20 of 70 patients (29%), and in 21 of 54 patients (39%).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Efficacy
plaincorrelationaln = 128- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Five patients (4%) died after 6 months from unrelated adverse events, and an additional 8 patients (6%) died after disease progression.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Table 1. (Continued.)
plainn = 5- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Minimal residual disease (MRD)-negative status (<10 -5 nucleated cells) was confirmed in 33 patients, representing 26% of all 128 patients who were treated and 79% of the 42 patients who had a complete response or better.”
- Also stated in: § Efficacy · plain
“Of the 42 patients with a complete or stringent complete response, 33 (79%) also had MRDnegative status at a sensitivity level of 10 -5 , corresponding to 26% (95% CI, 19 to 34) of the treated population; the remaining 9 patients (21%) could not be evaluated for MRD”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Abstract
plainn = 33- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § Efficacy · plain
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“High-grade hematologic toxic effects were common but transient.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The fact that MRDnegative responses occurred in approximately a quarter of the patients highlights the depth of response induced by ide-cel.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: MRD negativity at a sensitivity of 10^-5 is a valid measure of depth of response and clinical benefit.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites.All the patients provided written informed consent.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Study Oversight
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Nearly all tumors expressed BCMA, a finding that supports the use of ide-cel in relapsed and refractory myeloma without restriction based on tumor BCMA expression.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Discussion
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: BCMA expression is required for ide-cel efficacy, so lack of tumor BCMA expression would limit its use.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The primary efficacy analysis was performed in the population of patients treated with ide-cel (128 patients).”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Statistical Analysis
plainn = 128- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Between December 13, 2017, and November 13, 2018, a total of 140 patients were enrolled and underwent leukapheresis, of whom 128 received ide-cel infusions.Twelve patients discontinued the study before ide-cel infusion (including 1 patient who discontinued after unsuccessful manufacture of the CAR T-cell product)”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Patients
plainn = 140- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study was designed by the authors in conjunction with the sponsors and conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Study Oversight
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The sample size for the primary end point (overall response) was based on a onesample binomial test with normal approximation, under the assumption of 15% dropout between the time of enrollment and ide-cel treatment.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Statistical Analysis
plainn = 128- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Statistical tests were not performed on subgroup analyses.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Statistical Analysis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The primary end point was an overall response (partial response or better), defined according to IMWG Uniform Response Criteria for Multiple Myeloma 12 as assessed by an independent review committee.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > End Points and Assessments
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“MRD negativity was evaluated in bone marrow aspirates by next-generation sequencing (clonoSEQ, Adaptive Biotechnologies) with a minimum cutoff of 10 -5 nucleated cells.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > End Points and Assessments
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The actual doses delivered were within 20% of the target doses.”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > Study Design and Patients
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.Cytokine release syndrome was graded according to published criteria (Table S2).14”
§ Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma > End Points and Assessments
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper relies on this without support.
Soluble BCMA is a serum-based universal marker of myeloma burden.
“Soluble BCMA was assessed as a serum-based universal marker of myeloma burden.”
The paper relies on this without support.
Cross-trial comparisons of progression-free survival between the KarMMa study and trials of selinexor plus dexamethasone or belantamab mafodotin are valid.
“These efficacy results compare favorably with results in similarly heavily pretreated patients with relapsed or refractory myeloma treated with two recently approved regimens, selinexor plus dexamethasone and belantamab mafodotin (median progression-free survival, 3.7 months and 2.9 months, respectively).5,17”
The paper relies on this without support.
MRD negativity at a sensitivity of 10^-5 is a valid measure of depth of response and clinical benefit.
“The fact that MRDnegative responses occurred in approximately a quarter of the patients highlights the depth of response induced by ide-cel.”
The paper relies on this without support.
BCMA expression is required for ide-cel efficacy, so lack of tumor BCMA expression would limit its use.
“Nearly all tumors expressed BCMA, a finding that supports the use of ide-cel in relapsed and refractory myeloma without restriction based on tumor BCMA expression.”
The paper relies on this without support.
The absence of a detectable effect of antidrug antibodies on efficacy is not due to insufficient statistical power.
“Antidrug antibodies had no effect on the incidence of response or of complete response or better and had no noticeable effect on progression-free survival.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) are newly approved CAR-T products targeting BCMA that are active in relapsed refractory myeloma.89,90”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [89]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Safety of ide-cel remained consistent with the IA, with no parkinsonism, Guillain-Barré syndrome, or SPMs of T-cell origin reported. 13”
From Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. (2024) · cites this paper as [18]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Common side effects such as CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade, indicating manageable toxicity.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [243]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The median duration of response (mDOR) was 11 months in patients achieving CR and 19 months in those achieving stringent complete response (sCR).”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [243]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“A number of BCMA-directed therapies, including belantamab mafodotin, idecabtagene vicleucel (ide-cel), ciltacabtagene autoleucel (cilta-cel) and teclistamab, have shown efficacy in clinical trials and are approved for the treatment of relapsed or refractory multiple myeloma4–9.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [5]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Median DOR and PFS were 10.7 months and 8.8 months, respectively, for ide-cel, and were both not reached for cilta-cel5,6.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Although follow-up is still ongoing, among patients with ≥CR, DOR and PFS at 15 months with elranatamab were comparable to those observed with other BCMA-targeted T-cell-redirecting therapies, suggesting similar outcomes once a deep response is achieved5,24,25.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“High response rates have been reported with the BCMA chimeric antigen receptor (CAR) T-cell therapies, ide-cel and cilta-cel, with responses reported in 73% and 97% of treated patients, respectively.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In comparison to other BCMA-targeted T-cell-redirecting therapies, the rate of hematologic AEs with elranatamab was similar or lower after a similar follow-up4–6.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“CAR-T therapy requires that patients have access to specialized care centers and can wait the minimum 4-week period for production, which can result in attrition rates of approximately 10 to 15%,6-8”
From Teclistamab in Relapsed or Refractory Multiple Myeloma (2022) · cites this paper as [6]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Among 128 patients with relapsed refractory myeloma treated on a phase II trial, ide-cel was associated with a response rate of 73%.89 Thirty three percent of patients had a complete response or better. The median PFS was 8.8 months.”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [89]
The cited source says what the claim attributes to it.
In the citing paper
“Cytokine release syndrome was seen in 84%, and 5% were grade 3 or higher. Neurotoxicity was seen in 18%, and was grade 3 in 3%.”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [89]
The cited source says what the claim attributes to it.
In the citing paper
“Chimeric antigen receptor (CAR) T-cell therapy has shown promising ef fi cacy in patients with TCE R/RMM. 13-21”
From Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. (2024) · cites this paper as [18]
The cited source says what the claim attributes to it.
In the citing paper
“In the KarMMa study involving 128 patients with RRMM, the overall response rate (ORR) to a single infusion of Abecma was 73%, with a complete response (CR) rate of 33%.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [243]
The cited source says what the claim attributes to it.
In the citing paper
“Abecma has demonstrated the ability to induce rapid, deep, and long-lasting remissions with just one infusion, providing a new and effective personalized therapy option for MM patients [227, 243, 258, 259].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [243]
The cited source says what the claim attributes to it.
In the citing paper
“In contrast, higher-grade cytokine release syndrome and neurotoxic events have been described after CAR-T administration in patients with multiple myeloma.6,8”
From Teclistamab in Relapsed or Refractory Multiple Myeloma (2022) · cites this paper as [6]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Similarly, patients with advanced disease stage (R-ISS stage III) have consistently shown poorer outcomes irrespective of the therapy received4–6,19–22.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [5]
Experimental — accuracy not yet measuredIn the citing paper
“Recently approved therapies such as selinexor, 9 belantamab mafodotin, 10 idecabtagene vicleucel, 11 and ciltacabtagene autoleucel 12 have had clinical benefit in patients with relapsed or refractory multiple myeloma.”
From Talquetamab, a T-Cell–Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma (2022) · cites this paper as [11]
Citations
Cites
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Self-citationCurrent concepts in the diagnosis and management of cytokine release syndrome.
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Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma.
Raje, N., Berdeja, J., Lin, Y., Siegel, D., Jagannath, S., Madduri, D., Liedtke, M., Rosenblatt, J., Maus, M. V., Turka, A., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1817226 · Cited by 1,730
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Self-citationOral selinexor-dexamethasone for triple-class refractory multiple myeloma.
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Self-citationOutcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy.
Gandhi, U. H., Cornell, R. F., Lakshman, A., Gahvari, Z. J., McGehee, E., Jagosky, M. H., Gupta, R., Varnado, W., Fiala, M. A., Chhabra, S., et al. (2019) · Leukemia · doi:10.1038/s41375-019-0435-7 · Cited by 616
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Treatment of relapsed and refractory multiple myeloma
Sonneveld, P., & Broijl, A. (2016) · Haematologica · doi:10.3324/haematol.2015.129189 · Cited by 181
CAR T-cell therapy in hematologic malignancies: a voyage in progress.
Holstein, S. A., & Lunning, M. A. (2020) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1674 · Cited by 172
Understanding the mechanisms of resistance to CAR T-cell therapy in malignancies.
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Cited by
Sorted by citations
Items 2,001–2,100 of 2,535
Manufacturing of CAR-T Cells: The Assembly Line
Wang, X., & Rivière, I. (2022) · Cancer drug discovery and develogment/Cancer drug discovery and development · doi:10.1007/978-3-030-87849-8_8 · Cited by 1
Drumheller, B. R., Gebre, K., Lockhart, B., Margolskee, E. M., Obstfeld, A. E., Paessler, M. E., & Pillai, V. (2022) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.13850 · Cited by 1
Advances and perspective of the immunotherapy for relapsed/refractory multiple myeloma (interview)
Семочкин, С. В. (2022) · Oncohematology · doi:10.17650/1818-8346-2022-17-1-43-52 · Cited by 1
“Доля пациентов, получающих антиCD38моноклональные антитела, очевидно, растет.”
BackgroundInfluentialNew Frontiers: The Role of CAR T-Cell Therapy in Multiple Myeloma
McClanahan, A., & Spychalla, M. (2022) · Journal of the Advanced Practitioner in Oncology · doi:10.6004/jadpro.2022.13.3.30 · Cited by 1
“Approval for ide-cel was based on results of the pivotal phase II KarMMa trial, which consisted of heavily pretreated relapsed/ refractory multiple myeloma patients with highrisk cytogenetics and presence of extramedullary disease (Munshi et al., 2021).”
MethodAn update on novel multiple myeloma targets
Offidani, M., Corvatta, L., Morè, S., Manieri, V. M., & Olivieri, A. (2022) · Expert Review of Hematology · doi:10.1080/17474086.2022.2085088 · Cited by 1
“The main grade 3–4 side effects were neutropenia (89%) and thrombocitopenia (52%) [111].”
BackgroundFrey, N. V. (2022) · Transplantation and Cellular Therapy · doi:10.1016/j.jtct.2022.05.014 · Cited by 1
Kazandjian, D. G., & Landgren, O. (2022) · JAMA Oncology · doi:10.1001/jamaoncol.2022.2421 · Cited by 1
Leaving Lytic Lesions—Is There New Role for Radiation in Multiple Myeloma in the CAR T Era?
Ababneh, H., Raje, N. S., Yee, A. J., et al. (2022) · Practical Radiation Oncology · doi:10.1016/j.prro.2022.05.002 · Cited by 1
Self-citationCAR-T-Zell-Therapie – personalisierte zelluläre Immuntherapie im Jahr 2022
Metzger, J., Bethge, W. A., & Lengerke, C. (2022) · TumorDiagnostik & Therapie · doi:10.1055/a-1793-7528 · Cited by 1
High antigen density of BCMA: friend or foe to CAR T cells?
Gaballa, M., & Maus, M. V. (2022) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2022-005822 · Cited by 1
Mouhieddine, T. H., Moshier, E. L., Thibaud, S., Puliafito, B. R., Rattu, M. A., Jakubowski, R. M., Sanchez, L. J., Rossi, A., Rodriguez, C., Richard, S., et al. (2022) · Bone Marrow Transplantation · doi:10.1038/s41409-022-01848-7 · Cited by 1
Changing the Tune for CAR T-Cell Therapy: A Music City Experience in Remote Patient Monitoring
Baer, B., & Long, N. (2022) · Oncology Issues · doi:10.1080/10463356.2022.2124801 · Cited by 1
Impact of Precision Medicine in Oncology
Buchbinder, E. I., & Hodi, F. S. (2023) · The Cancer Journal · doi:10.1097/ppo.0000000000000641 · Cited by 1
“In relapsed and refractory multiple myeloma, CAR-T cells targeting B-cell maturation antigen have had high response rates.(64,65) The largest issue with CAR-T cell therapy that complicates its administration is the development of cytokine release syndrome and severe neurotoxicity.”
BackgroundCAR-T-sejtes kezelések a hematológiai betegségekben
Gergely, L. (2023) · Hematológia−Transzfuziológia · doi:10.1556/2068.2023.00158 · Cited by 1
Incorporating Immunotherapeutic Strategies in the Management of Relapsed/Refractory Multiple Myeloma
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Genomic drivers of large B-cell lymphoma resistance to CD19 CAR-T therapyPreprint
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Self-citationCAR-T therapy for multiple myeloma in China. Does it make sense financially?
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Cilta-cel salvages ide-cel failure in relapsed multiple myeloma by driving distinct immune responsesPreprint
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“While the patient’s superior response to cilta-cel is consistent with previous reports of superior clinical efficacy over ide-cel 5,6,49–51 , the underlying mechanisms remain unclear.”
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BCMA-Directed CAR T-Cells: Early Results and Future Directions
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Self-citationNew opportunities in immunotherapy in multiple myeloma
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“Based on the KarMMA study, ide-cel has been approved in the USA for patients previously treated with at least four lines of therapy including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 monoclonal antibody [9].”
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CAR-T-Zelltherapie: Konzept „One and Done“
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Jahrestagung der American Society of Hematology: Neue Optionen bei Rezidiven
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Self-citationRetractedBCMA-Directed CAR T Cells in Relapsed Refractory Multiple Myeloma: Highlights From SOHO 2021
Nodzon, L. (2022) · Journal of the Advanced Practitioner in Oncology · doi:10.6004/jadpro.2022.13.1.15
“Updates on both the phase II KarMMa trial and phase Ib/II CARTITUDE-1 study of chimeric antigen receptor (CAR) T cells in heavily pretreated R/R MM were presented during the ninth annual Society of Hematologic Oncology meeting (Berdeja et al., 2021; Munshi et al., 2021).”
BackgroundMethodYakoub‐Agha, I., & Einsele, H. (2022) · Springer eBooks · doi:10.1007/978-3-030-94353-0_16
Self-citationQu, X., An, G., Sui, W., Wang, T., Zhang, X., Yang, J., Zhang, Y., Zhang, L., Zhu, D., Huang, J., et al. (2022) · Research Square · doi:10.21203/rs.3.rs-1468511/v1
Belantamab mafodotin for relapsed or refractory multiple myeloma
Gil‐Sierra, M. D., & Briceño-Casado, M. D. P. (2022) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552221086265
“Pomalidomide could be a comparator for patients pretreated with combinations based on bortezomib – such as bortezomib, melphalan and prednisone ‒ or lenalidomide,5,22 and subsequently with treatments based on daratumumab.23–25 However, most of patients included in trials of cited schemes were treated with pomalidomide…”
BackgroundMethodInfluentialWatson, E., Gooding, S., & Ramasamy, K. (2022) · The Hematologist · doi:10.1182/hem.v19.3.202237
Qu, X., An, G., Sui, W., Wang, T., Zhang, X., Yang, J., Zhang, Y., Zhang, L., Zhu, D., Huang, J., et al. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4059229
2020–2021 Drug Updates in Hematologic Malignancies
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Updates in the Treatment of Multiple Myeloma
Kumar, S. K. (2022) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2022.5004
Chimeric antigen receptor T cells and management of toxicities: implications of biomarkers
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Roadmap for New Practitioners to Navigate the Multiple Myeloma LandscapePreprint
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When an embarrassment of riches isn’t enough
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Self-citationCAR T cells in multiple myeloma: Where we stand and where we might be going
Zojer, N., Schreder, M., & Ludwig, H. (2022) · memo - Magazine of European Medical Oncology · doi:10.1007/s12254-022-00825-6
“While CRS is frequently observed with both ide-cel and cilta-cel therapy (84–94%, mostly grade 1–2), there is an important difference in median time to onset of CRS between the products, 1 day with ide-cel, and 7 days with cilta-cel [2, 3, 11, 12, 17].”
BackgroundMethodInfluentialT Recent advances of FDA-approved CAR-T therapies in multiple myeloma
Zhang, Y. (2022) · Highlights in Science Engineering and Technology · doi:10.54097/hset.v8i.1182
“In addition, 95% of the patients (92/97) experienced cytokine release syndrome, but only 4 out of the 92 were grade 3 or 4 [25], [30].”
BackgroundInfluentialKhrystolubova, N. (2022) · The American Journal of Managed Care · doi:10.37765/ajmc.2022.89210
CAR-T cells—Real-time experience applying CAR-T cells—What we have learned so far
Greinix, H. T. (2022) · memo - Magazine of European Medical Oncology · doi:10.1007/s12254-022-00830-9
“CAR-T cell therapy targeting B cell maturation antigen (BCMA) has been approved by the FDA and EMA for treatment of patients with relapsed and refractory multiple myeloma (MM) based on high ORR of 82–98% and median progression-free survival (PFS) between 12 and more than 24 months [12, 13].”
BackgroundRoadmap for new practitioners to navigate the multiple myeloma landscape
Tam, T., Smith, E. L., Lozoya, E., Heers, H. M., & Allred, P. A. (2022) · Heliyon · doi:10.1016/j.heliyon.2022.e10586 · Cited by 1
EXABS-123-MM Additional Agents for RRMM - How Do/Will They Fit
Nooka, A. K., & Lonial, S. (2022) · Clinical Lymphoma Myeloma & Leukemia · doi:10.1016/s2152-2650(22)00649-8
Self-citationEXABS-169-MM Debate: Auto + Maintenance Should Remain SOC
Krishnan, A. Y., & Sanchez, J. F. (2022) · Clinical Lymphoma Myeloma & Leukemia · doi:10.1016/s2152-2650(22)00669-3
EXABS-170-MM CART Cell +/- Maintenance Will Replace Auto-SCT in NDMM
Usmani, S. Z. (2022) · Clinical Lymphoma Myeloma & Leukemia · doi:10.1016/s2152-2650(22)00670-x
Updates on Multiple Myeloma: What’s New in Risk Stratification, Treatment, and Prognosis
Mutahar, E. Y. (2022) · IntechOpen eBooks · doi:10.5772/intechopen.106159
17. Molecular Pathogenesis and Therapeutic Advances in Multiple Myeloma
Kizaki, M. (2021) · Nihon Naika Gakkai Zasshi · doi:10.2169/naika.110.2028
Evaluación de estrategias inmunes para el control del mieloma múltiple a largo plazo
Valls, J. D. (2022) · Gredos (University of Salamanca) · doi:10.14201/gredos.150753
Li, Z., Que, Y., Wang, D., et al. (2022) · Research Square · doi:10.21203/rs.3.rs-2168864/v1
Ghanem, B., & Shi, L. (2022) · Clinical Drug Investigation · doi:10.1007/s40261-022-01215-w
“Patients in this study received target doses of 150 × 106, 300 × 106, or 450 × 106 chimeric antigen receptor (CAR) T cells [9].”
MethodAssessing Pretransplant and Posttransplant Therapy Response in Multiple Myeloma Patients
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“It would seem that the response rates and survival outcomes of salvage autologous stem cell transplant are similar to recent findings with new Car-T cell therapy [38], which suggests that salvage autologous stem cell transplant represents a legitimate option in some individuals.”
dos Santos, M. H. (2022) · Digital Library of Theses and Dissertations (Universidade de São Paulo) · doi:10.11606/d.17.2022.tde-08112022-174507
CAR-T-Zell-Therapie – personalisierte zelluläre Immuntherapie im Jahr 2022
Niebling, J., Bethge, W. A., & Lengerke, C. (2022) · Onkologie up2date · doi:10.1055/a-1922-3641
“In der Zulassungsstudie JULIET [3] wurden 93 erwachsene Patient*innen mit rezidiviertem oder refraktärem (r/r) DLBCL behandelt.”
BackgroundInfluentialTeclistamab zur Therapie beim multiplen Myelom
Sester, L. S., Goldschmidt, H., & Nitschmann, S. (2022) · Die Innere Medizin · doi:10.1007/s00108-022-01438-1
Self-citationTwo to Tango: CD3/BCMA Bispecific Antibodies in Multiple Myeloma
Mailankody, S., & Usmani, S. Z. (2022) · The Hematologist · doi:10.1182/hem.v19.6.202261
Novel and Experimental Clone-Directed Therapies
Elemary, M., & Othman, I. (2022) · Springer eBooks · doi:10.1007/978-3-031-10131-1_22
Biology and status of chimeric antigen receptor-engineered T cell therapy
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Hämatologische Neoplasien und solide Tumore
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Cellular and Vaccine-Based Immunotherapy for Hematologic Malignancies
Avigan, Z. M., Boussi, L. S., & Avigan, D. (2023) · Interdisciplinary cancer research · doi:10.1007/16833_2023_131
Immunotherapy for Multiple Myeloma
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Lamb, M. G., Wiest, E. F., Filiano, A. J., et al. (2023) · Cytotherapy · doi:10.1016/j.jcyt.2023.01.006
CAR-T cell therapy in part of the B cell hematological malignancies
Gao, Z. (2023) · Highlights in Science Engineering and Technology · doi:10.54097/hset.v36i.5574
Multiples Myelom – Therapiestandards
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Metadata
- Authors
- Munshi, N. C., Anderson, L. D., Shah, N., Madduri, D., Berdeja, J., Lonial, S., Raje, N., Lin, Y., Siegel, D., Oriol, A., Moreau, P., Yakoub-Agha, I., Delforge, M., Cavo, M., Einsele, H., Goldschmidt, H., Weisel, K., Rambaldi, A., Reece, D., Petrocca, F., Massaro, M., Connarn, J. N., Kaiser, S., Patel, P., Huang, L., Campbell, T. B., Hege, K., & San-Miguel, J.
- Affiliations
- Harvard University (US)
- Mayo Clinic (US)
- Hackensack University Medical Center (US)
- From the Jerome Lipper Multiple Myeloma Center, Dana–Farber Cancer Institute (N.C.M.), the Veterans Affairs Boston Healthcare System, Harvard Medical School (N.C.M.), and Massachusetts General Hospital (N.R.), Boston, and bluebird bio, Cambridge (F.P., M.M.) — all in Massachusetts; Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas (L.D.A.); the University of California, San Francisco, San Francisco (N.S.); Icahn School of Medicine at Mount Sinai, New York ...
- ORCID
- Munshi, Nikhil C.
- Anderson, Larry D.
- Shah, Nina
- Madduri, Deepu
- Berdeja, Jesús
- Lonial, Sagar
- Raje, Noopur
- Lin, Yi
- Siegel, David
- Oriol, Albert
- Moreau, Philippe
- Yakoub-Agha, Ibrahim
- Delforge, Michel
- Einsele, Hermann
- Goldschmidt, Hartmut
- Weisel, Katja
- Rambaldi, Alessandro
- Reece, Donna
- Petrocca, Fabio
- Connarn, Jamie N.
- Kaiser, Shari
- Patel, Payal
- Huang, Liping
- Campbell, Timothy B.
- Hege, Kristen
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-02-25
- Volume
- 384
- Issue
- 8
- Pages
- 705-716
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3133229959
- Semantic Scholar
- fd96e2f87dff7d1153a17b78b56fbbab69cb714e
- Cited by
- 2,560
- References
- 17
- Citations by year
- 2026: 411 · 2025: 486 · 2024: 540 · 2023: 493 · 2022: 436 · 2021: 186
- FWCI
- 150.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, other-oa)
- Lirias (KU Leuven) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Keywords
- idecabtagene vicleucel, CAR T-cell therapy, relapsed/refractory multiple myeloma, BCMA, minimal residual disease, cytokine release syndrome, neurotoxicity, CAR T cell persistence, progression-free survival, complete response, neutropenia, anemia, thrombocytopenia, chimeric antigen receptor T cells
- MeSH terms
- Receptors, Chimeric Antigen, Progression-Free Survival, Cytokine Release Syndrome, Adult, Aged, Female, Hematologic Diseases, Humans, Male, Middle Aged, Multiple Myeloma, Recurrence, Biomarkers, Immunotherapy, Adoptive, Drug Resistance, Neoplasm
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