Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma
Open accessAbstract
Survival is poor among patients with triple-class–exposed relapsed and refractory multiple myeloma. Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy, previously led to deep, durable responses in patients with heavily pretreated relapsed and refractory multiple myeloma. Download a PDF of the Research Summary. In this international, open-label, phase 3 trial involving adults with relapsed and refractory multiple myeloma who had received two to four regimens previously (including immunomodulatory agents, proteasome inhibitors, and daratumumab) and who had disease refractory to the last regimen, we randomly assigned patients in a 2:1 ratio to receive either ide-cel (dose range, 150×106 to 450×106 CAR-positive T cells) or one of five standard regimens. The primary end point was progression-free survival. Key secondary end points were overall response (partial response or better) and overall survival. Safety was assessed. A total of 386 patients underwent randomization: 254 to ide-cel and 132 to a standard regimen. A total of 66% of the patients had triple-class–refractory disease, and 95% had daratumumab-refractory disease. At a median follow-up of 18.6 months, the median progression-free survival was 13.3 months in the ide-cel group, as compared with 4.4 months in the standard-regimen group (hazard ratio for disease progression or death, 0.49; 95% confidence interval, 0.38 to 0.65; P<0.001). A response occurred in 71% of the patients in the ide-cel group and in 42% of those in the standard-regimen group (P<0.001); a complete response occurred in 39% and 5%, respectively. Data on overall survival were immature. Adverse events of grade 3 or 4 occurred in 93% of the patients in the ide-cel group and in 75% of those in the standard-regimen group. Among the 225 patients who received ide-cel, cytokine release syndrome occurred in 88%, with 5% having an event of grade 3 or higher, and investigator-identified neurotoxic effects occurred in 15%, with 3% having an event of grade 3 or higher. Ide-cel therapy significantly prolonged progression-free survival and improved response as compared with standard regimens in patients with triple-class–exposed relapsed and refractory multiple myeloma who had received two to four regimens previously. The toxicity of ide-cel was consistent with previous reports. (Funded by 2seventy bio and Celgene, a Bristol-Myers Squibb company; KarMMa-3 ClinicalTrials.gov number, NCT03651128.) QUICK TAKE VIDEO SUMMARYIde-cel in Relapsed and Refractory Multiple Myeloma 02:00
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In the final PFS analysis of KarMMa-3, ide-cel maintained PFS and ORR benefit vs standard regimens in patients with TCE R/RMM, with deeper and more durable responses.
“In this fi nal PFS analysis of KarMMa-3, ide-cel bene fi t was maintained, 13 with substantially longer PFS and higher ORR vs SRs in patients with TCE R/RMM.”
From Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. (2024) · cites this paper as [13]
The trial results report longer progression-free survival and higher overall response with ide-cel than with standard regimens in triple-class-exposed relapsed and refractory multiple myeloma; the response table also shows deeper responses and a longer median response duration. But the Statistical Analysis section identifies the reported efficacy analysis as the second interim analysis, not the final PFS analysis. This paper therefore cannot establish that the benefit was maintained at the final analysis (page numbers unavailable in our copy). (LLM, conf=0.90)
Experimental — accuracy not yet measuredIde-cel safety profile remained consistent with prior reports, with no new safety signals, no additional CRS or iiNT events, and no parkinsonism, Guillain-Barré syndrome, or SPMs of T-cell origin reported.
“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 [13]
The discussion (section labeled “Months since Randomization”; page not provided) says ide-cel adverse events were consistent with previous studies and identifies no new safety signals. Our copy does not report the claimed absence of parkinsonism, Guillain-Barré syndrome, or T-cell-origin second primary malignancies, nor does it establish a comparison with an earlier interim analysis. The safety table reports CRS and neurotoxic events, but not whether additional events occurred after that analysis. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the KarMMa-3 interim analysis, ide-cel demonstrated significantly higher overall response rate versus standard regimens (71% vs 42%; P < .0001), with deeper responses (complete response rate 39% vs 5%).
“Ide-cel also demonstrated a signi fi cantly higher overall response rate (ORR) vs SRs (71% vs 42%; P < .0001), with deeper responses (complete response rate [CRR], 39% vs 5%, respectively). 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 [13]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn the prespecified KarMMa-3 interim analysis with 18.6 months median follow-up, a single ide-cel infusion demonstrated significantly longer median PFS versus standard regimens (13.3 vs 4.4 months; HR 0.49; 95% CI 0.38-0.65; P < .0001).
“In a prespeci fi ed KarMMa-3 interim analysis (IA) with 18.6 months median follow-up, a single ide-cel infusion demonstrated signi fi cantly longer median PFS vs SRs (13.3 vs 4.4 months), with a 51% lower risk of disease progression or death (hazard ratio [HR], 0.49; 95% con fi dence interval [CI], 0.38-0.65; P < .0001). 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 [13]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe majority of deaths that occurred since the initial analysis were due to progressive disease (ide-cel 20/31 [65%]; standard regimens 14/24 [58%]).
“The majority of deaths that occurred since the IA were due to PD (ide-cel, n = 20/31 [65%]; SRs, n = 14/24 [58%]). 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 [13]
The death outcomes on p. 1009 report that disease progression was the most common cause of death in both groups. They give cumulative figures of 44 of 75 deaths with ide-cel and 23 of 34 with standard regimens, not the claimed 20 of 31 and 14 of 24 deaths since the initial analysis. Our copy therefore supports the general cause-of-death statement but not the specified time period or counts. (LLM, conf=0.88)
Experimental — accuracy not yet measured
Both ide-cel and cilta-cel have subsequently shown superiority over standard relapsed myeloma regimens in randomized trials conducted earlier in the disease course.
“Both ide-cel and cilta-cel have subsequently shown superiority over standard relapsed myeloma regimens in randomized trials conducted earlier in the disease course (Table 9).159,160”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [159]
Chimeric antigen receptor T-cell therapy has shown promising efficacy in patients with triple-class-exposed relapsed and refractory multiple myeloma.
“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 [13]
Baseline disease characteristics were generally balanced between treatment arms.
“Baseline disease characteristics were generally balanced between treatment arms. 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 [13]
Patients in KarMMa-3 were more heavily pretreated than those in CARTITUDE-4; 100% vs 26% had TCE R/RMM, 66% vs 15% had TCR disease, 95% vs 22% were daratumumab refractory, and median prior regimens was 3 vs 2.
“Most notably, patients in KarMMa-3 were more heavily pretreated than those in CARTITUDE-4; 100% of patients in KarMMa-3 vs 26% in CARTITUDE-4 had TCE R/RMM, 66% vs 15% had TCR disease, and 95% vs 22% were daratumumab refractory (100% vs 25% were daratumumab exposed). Median number of prior regimens was 3 (range, 2-4) vs 2 (range, 1-3), respectively. 13,14”
From Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. (2024) · cites this paper as [13]
In a phase 3 trial of idecabtagene vicleucel involving patients who had received two to four lines of therapy for multiple myeloma, the median progression-free survival was 13.3 months (hazard ratio, 0.49 as compared with standard treatments).
“In a phase 3 trial of another CAR-T therapy, idecabtagene vicleucel, involving patients who had received two to four lines of therapy for multiple myeloma, investigators found a median progression-free survival of 13.3 months (hazard ratio, 0.49 as compared with standard treatments). 15”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [15]
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Self-citation
- Authors
- Rodriguez-Otero, P., Ailawadhi, S., Arnulf, B., Patel, K., Cavo, M., Nooka, A. K., Manier, S., Callander, N., Costa, L. J., Vij, R., Bahlis, N. J., Moreau, P., Solomon, S. R., Delforge, M., Berdeja, J., Truppel-Hartmann, A., Yang, Z., Favre-Kontula, L., Wu, F., Piasecki, J., Cook, M., & Giralt, S.
- Affiliations
- From Clínica Universidad de Navarra, Pamplona, Spain (P.R.-O.); Mayo Clinic, Jacksonville, FL (S.A.); Hôpital Saint-Louis, Assistance Publique–Hôpitaux de Paris, Université Paris Cité, Paris (B.A.), Centre Hospitalier Universitaire de Lille, Université de Lille, Lille (S.M.), and University Hospital of Nantes, Nantes (P.M.) — all in France; M.D. Anderson Cancer Center, University of Texas, Houston (K.P.); IRCCS Azienda Ospedaliero–Universitaria di Bologna, Seràgnoli Institute of Hematology, and the Department of Experimental, Diagnostic, and Specialty Medicine, Bologna University School of Medicine, Bologna, Italy (M. Cavo); Winship Cancer Institute of Emory University (A.K.N.) and Northside Hospital Cancer Institute (S.R.S.) — both in Atlanta; the University of Wisconsin Carbone Cancer Center, Madison (N.C.); the University of Alabama at Birmingham, Birmingham (L.J.C.); Washington University School of Medicine in St. Louis, St. Louis (R.V.); Arnie Charbonneau Cancer Institute, University of Calgary, Calga...
- The University of Texas MD Anderson Cancer Center (US)
- Northside Hospital (US)
- Memorial Sloan Kettering Cancer Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2023-03-16
- Volume
- 388
- Issue
- 11
- Pages
- 1002-1014
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4319812103
- Semantic Scholar
- b08a18ff41c77691322f630dec6d2f5c06435d40
- Cited by
- 781
- References
- 26
- Citations by year
- 2026: 201 · 2025: 231 · 2024: 245 · 2023: 101 · 2013: 1
- FWCI
- 160.71
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, other-oa)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- 2seventy bio
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Keywords
- relapsed/refractory multiple myeloma, ide-cel, idecabtagene vicleucel, CAR T-cell therapy, BCMA, progression-free survival, overall response rate, cytokine release syndrome, neurotoxicity, heavily pretreated patients, treatment efficacy and safety
- MeSH terms
- Antineoplastic Agents, Immunological, Receptors, Chimeric Antigen, Progression-Free Survival, Adult, Antineoplastic Combined Chemotherapy Protocols, Humans, Multiple Myeloma, Recurrence, Immunotherapy, Adoptive
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