Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma
Open accessAbstract
BACKGROUND: Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival. RESULTS: A prespecified interim analysis showed that the rate of progression-free survival was significantly higher in the daratumumab group than in the control group; the 12-month rate of progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group. After a median follow-up period of 7.4 months, the median progression-free survival was not reached in the daratumumab group and was 7.2 months in the control group (hazard ratio for progression or death with daratumumab vs. control, 0.39; 95% confidence interval, 0.28 to 0.53; P<0.001). The rate of overall response was higher in the daratumumab group than in the control group (82.9% vs. 63.2%, P<0.001), as were the rates of very good partial response or better (59.2% vs. 29.1%, P<0.001) and complete response or better (19.2% vs. 9.0%, P=0.001). Three of the most common grade 3 or 4 adverse events reported in the daratumumab group and the control group were thrombocytopenia (45.3% and 32.9%, respectively), anemia (14.4% and 16.0%, respectively), and neutropenia (12.8% and 4.2%, respectively). Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients in the daratumumab group; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of the patients), and in 98.2% of these patients, they occurred during the first infusion. CONCLUSIONS: Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than bortezomib and dexamethasone alone and was associated with infusion-related reactions and higher rates of thrombocytopenia and neutropenia than bortezomib and dexamethasone alone. (Funded by Janssen Research and Development; ClinicalTrials.gov number, NCT02136134.).
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Daratumumab targets CD38 (a receptor highly expressed on myeloma cells) and has become a favorite for later line induction regimens.
“The recently approved monoclonal antibody, daratumumab, which targets CD38 (a receptor highly expressed on myeloma cells), has become a favorite for later line induction regimens [35,36].”
From Epidemiology, Staging, and Management of Multiple Myeloma (2021) · cites this paper as [35]
The ABSTRACT (pp. 1–2) says daratumumab targets CD38, which is highly expressed on myeloma cells, and reports its approval for certain previously treated patients. The Discussion (p. 11) reports benefits in relapsed multiple myeloma, but the paper does not establish that daratumumab had become a favored later-line induction regimen. (LLM, conf=0.88)
Experimental — accuracy not yet measuredDaratumumab is a cornerstone of standard-of-care multiple myeloma regimens with demonstrated survival benefit across all lines.
“Daratumumab, an anti-CD38–targeting monoclonal antibody (mAb), is a cornerstone of standard-of-care MM regimens with demonstrated survival benefit across all lines.9–14”
From Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma (2026) · cites this paper as [11]
The Background (p. 1) identifies daratumumab as an anti-CD38 monoclonal antibody, and the Discussion (p. 11) reports improved progression-free survival when it was added to bortezomib and dexamethasone for relapsed multiple myeloma. But the Discussion explicitly says the trial could not assess an overall-survival benefit, and the paper does not establish benefit across all lines of therapy or daratumumab's status as a cornerstone of standard care. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the CASTOR study, daratumumab plus bortezomib and dexamethasone (DVd) produced a higher overall response rate (85% vs 63%) and longer progression-free survival (16.7 vs 7.1 months) than bortezomib plus dexamethasone (Vd) in patients with relapsed/refractory multiple myeloma.
“In the CASTOR study, daratumumab in combination with bortezomib and dexamethasone (DVd) demonstrated superior outcomes compared to bortezomib plus dexamethasone (Vd) in patients with RRMM. The overall response rate (ORR) was significantly higher with DVd (85%) compared to Vd (63%). The PFS was also significantly longer with DVd (16.7 months) compared to Vd (7.1 months) [159].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [159]
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 measuredAfter the implementation of guidelines from other studies of daratumumab regarding the management of infusion-related reactions, infusion-related reactions were consistent with daratumumab monotherapy and combination therapy, were mostly of grade 1 or 2, and usually occurred during the first infusion.
“After the implementation of guidelines from other studies of daratumumab regarding the management of infusion-related reactions, infusion-related reactions were consistent with daratumumab monotherapy 9,10 and combination therapy, 18,19,32 were mostly of grade 1 or 2, and usually occurred during the first infusion.”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [18]
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 measuredA phase 3 trial of bortezomib and dexamethasone, with or without daratumumab, met its primary end point at the interim analysis and showed a significantly higher rate of progression-free survival, with a 61% lower risk of progression or death in the daratumumab group than in the control group.
“A phase 3 trial of bortezomib and dexamethasone, with or without daratumumab, met its primary end point at the interim analysis and showed a significantly higher rate of progression-free survival, with a 61% lower risk of progression or death in the daratumumab group than in the control group.18”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [18]
In the CASTOR trial, the addition of daratumumab to a standard-of-care regimen of bortezomib and dexamethasone was associated with a significantly lower risk of disease progression or death.
“As in our trial (POLLUX), the addition of daratumumab to a standard-of-care regimen of bortezomib and dexamethasone in the CASTOR trial was associated with a significantly lower risk of disease progression or death.18”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [18]
Treatment responses and disease progression were determined according to the International Myeloma Working Group criteria with the use of a validated computer algorithm.
“Treatment responses and disease progression were determined according to the International Myeloma Working Group criteria 16 with the use of a validated computer algorithm. 19”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [19]
In relapsed mantle cell lymphoma, single-agent lenalidomide produced a significant increase in median PFS (8.7 versus 5.2 months; HR 0.61; p=0.004) compared with provider's choice chemotherapy in patients with relapsed or refractory disease, leading to its FDA approval in 2013.
“In relapsed mantle cell lymphoma single agent lenalidomide produced a significant increase in median PFS (8.7 versus 5.2 months; HR 0.61; p=0.004) compared to provider’s choice chemotherapy in patients with relapsed or refractory disease, leading to its FDA approval in 201373,74.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [73]
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“Datain E , F ,and G are presented as the mean±SEM of three biological replicates.”
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- Authors
- Palumbo, A., Chanan-Khan, A., Weisel, K., Nooka, A. K., Masszi, T., Beksac, M., Spicka, I., Hungria, V., Munder, M., Mateos, M. V., Mark, T. M., Qi, M., Schecter, J., Amin, H., Qin, X., Deraedt, W., Ahmadi, T., Spencer, A., & Sonneveld, P.
- Affiliations
- Semmelweis University (HU)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-08-25
- Volume
- 375
- Issue
- 8
- Pages
- 754-766
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2512106959
- Semantic Scholar
- 4b6955b411cfca27b45ad1343fedbdf3587c213d
- Cited by
- 1,522
- References
- 36
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- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
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- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Minerva Access (University of Melbourne) (submittedVersion)
- CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- daratumumab, bortezomib, dexamethasone, relapsed multiple myeloma, refractory multiple myeloma, anti-CD38 monoclonal antibody, progression-free survival, overall response rate, combination therapy, thrombocytopenia, infusion reactions, adverse events, treatment safety, newly diagnosed multiple myeloma
- MeSH terms
- Bortezomib, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Multiple Myeloma, Recurrence, Disease-Free Survival, Drug Resistance, Neoplasm, ADP-ribosyl Cyclase 1
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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