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Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma
Open accessAbstract
BACKGROUND: Multiple myeloma cells uniformly overexpress CD38. We studied daratumumab, a CD38-targeting, human IgG1κ monoclonal antibody, in a phase 1-2 trial involving patients with relapsed myeloma or relapsed myeloma that was refractory to two or more prior lines of therapy. METHODS: In part 1, the dose-escalation phase, we administered daratumumab at doses of 0.005 to 24 mg per kilogram of body weight. In part 2, the dose-expansion phase, 30 patients received 8 mg per kilogram of daratumumab and 42 received 16 mg per kilogram, administered once weekly (8 doses), twice monthly (8 doses), and monthly for up to 24 months. End points included safety, efficacy, and pharmacokinetics. RESULTS: No maximum tolerated dose was identified in part 1. In part 2, the median time since diagnosis was 5.7 years. Patients had received a median of four prior treatments; 79% of the patients had disease that was refractory to the last therapy received (64% had disease refractory to proteasome inhibitors and immunomodulatory drugs and 64% had disease refractory to bortezomib and lenalidomide), and 76% had received autologous stem-cell transplants. Infusion-related reactions in part 2 were mild (71% of patients had an event of any grade, and 1% had an event of grade 3), with no dose-dependent adverse events. The most common adverse events of grade 3 or 4 (in ≥ 5% of patients) were pneumonia and thrombocytopenia. The overall response rate was 36% in the cohort that received 16 mg per kilogram (15 patients had a partial response or better, including 2 with a complete response and 2 with a very good partial response) and 10% in the cohort that received 8 mg per kilogram (3 had a partial response). In the cohort that received 16 mg per kilogram, the median progression-free survival was 5.6 months (95% confidence interval [CI], 4.2 to 8.1), and 65% (95% CI, 28 to 86) of the patients who had a response did not have progression at 12 months. CONCLUSIONS: Daratumumab monotherapy had a favorable safety profile and encouraging efficacy in patients with heavily pretreated and refractory myeloma. (Funded by Janssen Research and Development and Genmab; ClinicalTrials.gov number, NCT00574288.).
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“Daratumumab, a human IgGκ monoclonal antibody that targets CD38, 8 has shown substantial single-agent efficacy and a manageable safety profile in phase 1-2 studies involving patients with heavily pretreated relapsed or refractory multiple myeloma, with reported overall response rates of 29% and 36%.9,10”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [10]
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“Elotuzumab targets SLAMF7; daratumumab and isatuximab target CD38 respectively.84–87”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [85]
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“Daratumumab is active in relapsed, refractory multiple myeloma.85”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [85]
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“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 [10]
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“Daratumumab with lenalidomide and dexamethasone was associated with clinically manageable adverse events that were consistent with the known toxic effects of lenalidomide and dexamethasone 27,28,30,31 and of daratumumab.9,10”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [10]
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Latif, A., Kapoor, V., Sipra, Q. U. A. R., Malik, S. U., Bilal, J., Riaz, I. B., & Faiz, A. (2018) · Cureus · doi:10.7759/cureus.2438 · Cited by 9
Multiple Myeloma: Possible Cure from the Sea
Capalbo, A., & Lauritano, C. (2022) · Cancers · doi:10.3390/cancers14122965 · Cited by 9
L’Imperio, V., Cazzaniga, G., Vergani, B., Smith, A. J., Alberici, F., & Pagni, F. (2022) · Kidney Diseases · doi:10.1159/000527056 · Cited by 9
A Critical Analysis of the FDA’s Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity
Niazi, S. K. (2023) · Pharmaceuticals · doi:10.3390/ph16111556 · Cited by 10
Niazi, S. K. (2023) · Clinical Pharmacology in Drug Development · doi:10.1002/cpdd.1349 · Cited by 9
Peclat, T., Agorrody, G., Colman, L., Kashyap, S., Zeidler, J. D., Chini, C. C. S., Warner, G. M., Thompson, K. L., Dalvi, P., Beckedorff, F., et al. (2024) · Cardiovascular Research · doi:10.1093/cvr/cvae025 · Cited by 9
Novel Combination Treatments in Multiple Myeloma.
Nooka, A. K., & Lonial, S. (2016) · PubMed · Cited by 9
Suto, Y., Sato, M., Fujimori, K., Kitabatake, S., Okayama, M., Ichikawa, D., Matsushita, M., Yamagiwa, N., Iwasaki, G., Kiuchi, F., et al. (2017) · Bioorganic & Medicinal Chemistry Letters · doi:10.1016/j.bmcl.2017.08.054 · Cited by 9
Present and Future of Immunotherapy in the Management of Multiple Myeloma
Baljević, M., & Holstein, S. A. (2018) · Journal of Oncology Practice · doi:10.1200/jop.18.00111 · Cited by 9
Dose Selection for Multiple Myeloma in Modern Era
Wang, S., Salgado, L. R., Adler, A., Chang, S., Ru, M., Moshier, E. L., Dharmarajan, K. V., Cho, H. J., & Bakst, R. L. (2019) · Practical Radiation Oncology · doi:10.1016/j.prro.2019.02.009 · Cited by 9
Rifkin, R. M., Singer, D., Aguilar, K. M., Baidoo, B., & Maiese, E. M. (2019) · Clinical Therapeutics · doi:10.1016/j.clinthera.2019.03.013 · Cited by 9
Daratumumab subcutaneous formulation for the treatment of multiple myeloma
Paul, B. A., Hamadeh, I. S., Atrash, S., Bhutani, M., Voorhees, P. M., & Usmani, S. Z. (2020) · Expert Opinion on Biological Therapy · doi:10.1080/14712598.2020.1806231 · Cited by 9
Lu, H., Molony, R. D., Chen, D., Jang, S., Wolf, B., Ewert, S., Flaherty, M. M., Xu, F., Isim, S., Shim, Y., et al. (2020) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-19-0003 · Cited by 9
Monoclonal antibodies as an addition to current myeloma therapy strategies
Jullien, M., Touzeau, C., & Moreau, P. (2020) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2021.1837627 · Cited by 10
Monoclonal Antibodies: Leading Actors in the Relapsed/Refractory Multiple Myeloma Treatment
Morè, S., Petrucci, M. T., Corvatta, L., Fazio, F., Offidani, M., & Olivieri, A. (2020) · Pharmaceuticals · doi:10.3390/ph13120426 · Cited by 9
New regimens and directions in the management of newly diagnosed multiple myeloma
Bal, S., Giri, S., Godby, K. N., & Costa, L. J. (2021) · American Journal of Hematology · doi:10.1002/ajh.26080 · Cited by 9
Cook, G., Corso, A., Streetly, M. J., Mendeleeva, L. P., Ptushkin, V. V., Chan, E. S., Ukropec, J., Iraqi, W., Al-Akabawi, A., Pei, H., et al. (2021) · Oncology and Therapy · doi:10.1007/s40487-020-00137-x · Cited by 9
Huynh, T., Corre, E., Lemonnier, M.-P., Duléry, R., Marjanovic, Z., Jaff, N., Lapusan, S., Mohty, M., Garderet, L., & Coppo, P. (2021) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.1080/10428194.2021.1907373 · Cited by 9
Genomic Instability and Replicative Stress in Multiple Myeloma: The Final Curtain?
Botrugno, O. A., & Tonon, G. (2021) · Cancers · doi:10.3390/cancers14010025 · Cited by 9
Wang, K., Lee, E., Kenis, S., Hallam, S. L., Haroon, A., Wan, S., Rabin, N. K., Rojas‐García, A., Padhani, A. R., & Adeleke, S. M. (2022) · European Radiology · doi:10.1007/s00330-021-08311-z · Cited by 9
Non-coding RNAs and exosomal ncRNAs in multiple myeloma: An emphasis on molecular pathways
Hashemi, M., Roshanzamir, S. M., Paskeh, M. D. A., Karimian, S. S., Mahdavi, M. S., Kheirabad, S. K., Naeemi, S., Taheriazam, A., Salimimoghadam, S., Entezari, M., et al. (2023) · European Journal of Pharmacology · doi:10.1016/j.ejphar.2022.175380 · Cited by 10
Management of Multiple Myeloma with Second-Generation Antibody-Drug Conjugates
Robak, P. J., & Robak, T. (2016) · BioDrugs · doi:10.1007/s40259-016-0165-6 · Cited by 9
Treatment of Relapsed/Refractory Multiple Myeloma
Neri, P. E., Bahlis, N. J., Paba‐Prada, C. E., & Richardson, P. G. G. (2016) · Cancer treatment and research · doi:10.1007/978-3-319-40320-5_10 · Cited by 10
Self-citationShould minimal residual disease negativity be the end point of myeloma therapy?
Anderson, K. C. (2017) · Blood Advances · doi:10.1182/bloodadvances.2016000117 · Cited by 9
Current and developing synthetic pharmacotherapy for treating relapsed/refractory multiple myeloma
Podar, K., & Pecherstorfer, M. (2017) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2017.1340942 · Cited by 9
Metadata
- Authors
- Lokhorst, H. M., Plesner, T., Laubach, J. P., Nahi, H., Gimsing, P., Hansson, M., Minnema, M. C., Lassen, U., Krejcik, J., Palumbo, A., van de Donk, N. W. C. J., Ahmadi, T., Khan, I., Uhlar, C. M., Wang, J., Sasser, A. K., Losic, N., Lisby, S., Basse, L., Brun, N., & Richardson, P. G.
- Affiliations
- University of Copenhagen (DK)
- University of Southern Denmark (DK)
- Harvard University (US)
- Karolinska University Hospital (SE)
- Lund University (SE)
- University Medical Center Utrecht (NL)
- University of Turin (IT)
- Janssen Research & Development (United States) (US)
- Genmab (Denmark) (DK)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-09-24
- Volume
- 373
- Issue
- 13
- Pages
- 1207-1219
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1902692042
- Semantic Scholar
- c731f1036338cb22a95a42420cb4ccf650d6c359
- Cited by
- 1,117
- References
- 27
- Citations by year
- 2026: 39 · 2025: 57 · 2024: 63 · 2023: 87 · 2022: 83 · 2021: 134 · 2020: 131 · 2019: 108 · 2018: 129 · 2017: 125 · 2016: 143 · 2015: 14
- FWCI
- 107.52
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Janssen Research and Development
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Keywords
- multiple myeloma, daratumumab, CD38, monoclonal antibodies, relapsed/refractory multiple myeloma, monotherapy, dose escalation, progression-free survival, overall response rate, infusion reactions, pharmacokinetics, autologous stem cell transplantation, lenalidomide-refractory disease, bortezomib-refractory disease, pneumonia, thrombocytopenia, complete response, very good partial response
- MeSH terms
- Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Multiple Myeloma, Pneumonia, Thrombocytopenia, 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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