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 "title": "Daratumumab regimen",
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 "excerpt": "A daratumumab regimen is a multiple myeloma treatment combining the CD38 antibody daratumumab with backbone drugs such as dexamethasone, bortezomib, or lenalidomide, across newly diagnosed and relapsed disease.",
 "snippet": "A daratumumab regimen is a multiple myeloma treatment combining the CD38 antibody daratumumab with backbone drugs such as dexamethasone, bortezomib, or lenalidomide, across newly diagnosed and relapsed disease.",
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 "markdown": "# Daratumumab regimen\n\nA daratumumab regimen is a multiple myeloma treatment that combines daratumumab, a human IgG1κ monoclonal antibody against CD38, with backbone drugs such as dexamethasone, a proteasome inhibitor (bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide, pomalidomide, or thalidomide), melphalan, or selinexor. The named regimens now span newly diagnosed disease (DVMP, D-Rd, D-VRd, D-VTd), relapsed/refractory disease (DVd, DRd, DKd, DPd)<sup>[1](https://www.mdpi.com/2072-6694/15/19/4894)</sup>, post-transplant maintenance, and light-chain amyloidosis.<sup>[2](https://link.springer.com/article/10.1007/s00277-022-04917-5)</sup>\n\n| Key fact | Detail |\n|---|---|\n| Target and drug class | Human IgG1κ monoclonal antibody binding CD38, a 48 kDa glycoprotein on clonal plasma cells<sup>[3](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b)</sup><sup> • </sup><sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup> |\n| Intravenous dose | 16 mg/kg actual body weight by infusion<sup>[3](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b)</sup> |\n| Subcutaneous dose | 1,800 mg daratumumab with 30,000 units hyaluronidase over about 3 to 5 minutes<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup> |\n| Relapsed disease benefit | CASTOR: HR 0.39 for progression or death with DVd vs Vd<sup>[5](https://www.nejm.org/doi/full/10.1056/NEJMoa1606038)</sup>; CANDOR: median PFS 28.4 vs 15.2 months for DKd vs Kd<sup>[6](https://pmc.ncbi.nlm.nih.gov/articles/PMC10368773/)</sup> |\n| Newly diagnosed benefit | ALCYONE: 18-month PFS 71.6% vs 50.2% (HR 0.50)<sup>[7](https://www.nejm.org/doi/full/10.1056/NEJMoa1714678)</sup>; PERSEUS: 48-month PFS 84.3% vs 67.7% (HR 0.42)<sup>[8](https://chi.scholasticahq.com/article/133682-consensus-guidelines-and-recommendations-for-the-cd38-monoclonal-antibody-based-quadruplet-therapy-and-management-in-clinical-practice-for-newly-diagn)</sup> |\n| Blood-bank interference | Positive indirect Coombs test for up to 6 months after the last dose; managed with DTT-treated cells or genotyping<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup> |\n\n## How it works\n\nCD38 is a transmembrane glycoprotein (48 kDa) expressed on hematopoietic cells, including the clonal plasma cells of multiple myeloma.<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup> [Daratumumab](https://www.edgepedia.org/daratumumab) kills CD38-expressing tumor cells by inducing apoptosis directly through Fc-mediated cross-linking and by immune-mediated lysis.<sup>[3](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b)</sup> The immune effector mechanisms are antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC).<sup>[9](https://pmc.ncbi.nlm.nih.gov/articles/PMC10760401/)</sup> CDC appears to be a more prominent effector mechanism for daratumumab than for the related antibody isatuximab, and patients progressing on daratumumab showed elevated complement inhibitors CD55 and [CD59](https://www.edgepedia.org/cd59).<sup>[2](https://link.springer.com/article/10.1007/s00277-022-04917-5)</sup>\n\nImmunomodulation is a second layer of activity. Daratumumab depletes CD38-expressing immunosuppressive regulatory T and B cells and myeloid-derived suppressor cells.<sup>[9](https://pmc.ncbi.nlm.nih.gov/articles/PMC10760401/)</sup> CD38's ectoenzyme activity also generates immunosuppressive adenosine, so the antibody may support T-cell responses by reducing adenosine production.<sup>[9](https://pmc.ncbi.nlm.nih.gov/articles/PMC10760401/)</sup>\n\n## How it is done\n\nIntravenous daratumumab is dosed at 16 mg/kg actual body weight.<sup>[3](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b)</sup> The subcutaneous formulation (Darzalex Faspro) is given as a fixed 1,800 mg dose with 30,000 units hyaluronidase over approximately 3 to 5 minutes.<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup> For most combinations and for monotherapy, daratumumab is given weekly for weeks 1 to 8, every two weeks for weeks 9 to 24, then every four weeks from week 25.<sup>[2](https://link.springer.com/article/10.1007/s00277-022-04917-5)</sup><sup> • </sup><sup>[10](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s035lbl.pdf)</sup> With carfilzomib, week 1 uses two divided daratumumab doses of 8 mg/kg on days 1 and 2 before moving to 16 mg/kg weekly<sup>[11](https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf)</sup><sup> • </sup><sup>[12](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2820%2930734-0/abstract)</sup>; the first intravenous dose can similarly be split over two days in other regimens.<sup>[13](https://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Lymphoma-Myeloma/MYDARCBDF_Protocol.pdf)</sup>\n\nBackbone drugs run on their own cycles. In ALCYONE, daratumumab 16 mg/kg was combined with bortezomib 1.3 mg/m² subcutaneously, melphalan 9 mg/m², and prednisone 60 mg/m² on days 1 to 4 of each 42-day cycle, with dexamethasone 20 mg.<sup>[7](https://www.nejm.org/doi/full/10.1056/NEJMoa1714678)</sup> Typically the partners stop after a fixed number of cycles while daratumumab continues: in a subcutaneous DVd protocol, bortezomib and dexamethasone stop after 8 cycles and daratumumab continues until progression<sup>[14](https://www.kmcc.nhs.uk/s3/assets/haem-myel-041-daratumumab-sc-in-combination-with-bortezomib-%28d1,-4,-8-&-11%29-and-dexamethasone-v4.pdf)</sup>; in the BMP-daratumumab regimen, the 42-day combination runs for 9 cycles, then daratumumab monotherapy continues every 28 days until progression or unacceptable toxicity.<sup>[15](https://www.cancercareontario.ca/en/system/files_force/BMPDARA_HEM_MY_P.pdf?download=1)</sup>\n\n## Variants\n\nIntravenous daratumumab infusions average 7 hours for initial doses and 3 to 4 hours for subsequent doses; the subcutaneous formulation, first approved in May 2020 (FDA) and June 2020 (EMA), is co-formulated with recombinant human hyaluronidase PH20 and injected as an 1,800 mg flat dose over about 3 to 5 minutes.<sup>[9](https://pmc.ncbi.nlm.nih.gov/articles/PMC10760401/)</sup> Subcutaneous administration lowers the infusion-reaction rate to about 15%, versus 27.7% for intravenous daratumumab in ALCYONE.<sup>[2](https://link.springer.com/article/10.1007/s00277-022-04917-5)</sup><sup> • </sup><sup>[7](https://www.nejm.org/doi/full/10.1056/NEJMoa1714678)</sup> Non-inferiority was shown in the COLUMBA and PLEIADES trials<sup>[2](https://link.springer.com/article/10.1007/s00277-022-04917-5)</sup>, and PLEIADES evaluated the subcutaneous formulation plus weekly carfilzomib 70 mg/m² and dexamethasone 40 mg in relapsed disease.<sup>[16](https://www.nature.com/articles/s41408-023-00805-x)</sup>\n\nIn the phase 2 GEM-SELIBORDARA study of selinexor plus DVd, part 1 (patients with at least three prior lines, 24 patients) had an overall response rate of 50% and median PFS of 7 months, while part 2 (at least one prior line, 33 patients) had a response rate of 82%, CR or better in 33%, and median PFS of 24 months.<sup>[17](https://haematologica.org/article/view/haematol.2023.284089)</sup> A National Cancer Institute-sponsored phase 2 trial (NCT06169215) started in July 2024 compares Dara-SVD (daratumumab, selinexor, bortezomib, dexamethasone) against Dara-RVD in high-risk newly diagnosed myeloma; all five drugs are FDA-approved for myeloma, but selinexor only for relapsed disease.<sup>[18](https://clinicaltrials.gov/study/NCT06169215)</sup>\n\n## Applications\n\n**Relapsed/refractory disease.** In CASTOR, adding daratumumab to bortezomib-dexamethasone gave a hazard ratio for progression or death of 0.39<sup>[5](https://www.nejm.org/doi/full/10.1056/NEJMoa1606038)</sup>; at a median follow-up of 72.6 months, median overall survival was 49.6 months for DVd versus 38.5 months for Vd (HR 0.74).<sup>[19](https://www.eviq.org.au/haematology/multiple-myeloma/4396-multiple-myeloma-dvd-daratumumab-subcutaneou)</sup>\n\n**Newly diagnosed, transplant-ineligible.** In ALCYONE (706 patients, VMP with or without daratumumab), 18-month PFS was 71.6% versus 50.2% (HR 0.50), overall response rate 90.9% versus 73.9%, and MRD negativity (no detectable minimal residual disease remaining) at 10⁻⁵ 22.3% versus 6.2%.<sup>[7](https://www.nejm.org/doi/full/10.1056/NEJMoa1714678)</sup>\n\n**Transplant-eligible and quadruplet frontline.** In CASSIOPEIA, adding daratumumab to VTd improved MRD negativity (64% vs 44%); in GRIFFIN, D-VRd improved MRD negativity (64% vs 30%) and, at median follow-up of 49.6 months, 4-year PFS was 87.2% versus 70.0% (HR 0.45).<sup>[8](https://chi.scholasticahq.com/article/133682-consensus-guidelines-and-recommendations-for-the-cd38-monoclonal-antibody-based-quadruplet-therapy-and-management-in-clinical-practice-for-newly-diagn)</sup> Post-transplant daratumumab maintenance in CASSIOPEIA reduced the risk of progression or death by 51% versus observation (HR 0.49), with median PFS not reached at six years versus 45.8 months.<sup>[20](https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-based-regimens-significantly-improve-clinical-outcomes-in-both-transplant-eligible-and-ineligible-patients-who-are-newly-diagnosed-with-multiple-myeloma)</sup> In PERSEUS, D-VRd achieved CR-or-better rates of 87.9% versus 70.1% and MRD negativity of 75.2% versus 47.5%, with 48-month PFS of 84.3% versus 67.7% (HR 0.42).<sup>[8](https://chi.scholasticahq.com/article/133682-consensus-guidelines-and-recommendations-for-the-cd38-monoclonal-antibody-based-quadruplet-therapy-and-management-in-clinical-practice-for-newly-diagn)</sup> In CEPHEUS (transplant-ineligible or transplant-deferred patients), D-VRd produced MRD negativity of 60.9% versus 39.4% and a 43% lower risk of progression or death (HR 0.57).<sup>[21](https://www.nature.com/articles/s41591-024-03485-7)</sup>\n\nA network meta-analysis of 17 trials (7,261 patients) estimated an overall PFS hazard ratio of 0.53 and overall survival hazard ratio of 0.68 for daratumumab-based regimens, identifying Dara-VRd, Dara-KRD, Dara-Rd, and Dara-CRD as optimal frontline options.<sup>[22](https://link.springer.com/article/10.1186/s13643-025-02804-4)</sup> Monotherapy is reserved for heavily pretreated patients: in trials such as GEN501 and SIRIUS, single-agent daratumumab gave an overall response rate of 31% and median overall survival of 20.1 months.<sup>[5](https://www.nejm.org/doi/full/10.1056/NEJMoa1606038)</sup><sup> • </sup><sup>[23](https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.624661/full)</sup>\n\n## Limitations and alternatives\n\nGrade 3 or 4 infections affected 23.1% of daratumumab-treated patients versus 14.7% of controls in ALCYONE<sup>[7](https://www.nejm.org/doi/full/10.1056/NEJMoa1714678)</sup>, and DVd in CASTOR was associated with higher rates of thrombocytopenia and neutropenia than Vd alone.<sup>[5](https://www.nejm.org/doi/full/10.1056/NEJMoa1606038)</sup> Antiviral prophylaxis against herpes zoster reactivation should be considered.<sup>[15](https://www.cancercareontario.ca/en/system/files_force/BMPDARA_HEM_MY_P.pdf?download=1)</sup>\n\nDaratumumab binds CD38 on red blood cells and causes a positive indirect antiglobulin (Coombs) test, with pan-reactivity that can persist up to 6 months after the last dose, masking antibodies to minor antigens in antibody screening and cross-matching.<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup><sup> • </sup><sup>[2](https://link.springer.com/article/10.1007/s00277-022-04917-5)</sup> Mitigation uses reagent red cells treated with dithiothreitol (DTT) to disrupt daratumumab binding, or genotyping; because the Kell system is DTT-sensitive, K-negative units must be supplied after DTT-based testing.<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup> Patients should be typed and screened before starting therapy, and in emergencies non-cross-matched ABO/RhD-compatible red cells may be given per local blood-bank practice.<sup>[4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)</sup>\n\nPublished comparisons establish daratumumab's benefit against its own backbone therapies. Daratumumab has not been approved for transplant-eligible newly diagnosed disease in China or Australia as of the 2025 meta-analysis<sup>[22](https://link.springer.com/article/10.1186/s13643-025-02804-4)</sup>, while Dara-VRd has been included in NCCN Guidelines Version 1.2025 for primary treatment.<sup>[8](https://chi.scholasticahq.com/article/133682-consensus-guidelines-and-recommendations-for-the-cd38-monoclonal-antibody-based-quadruplet-therapy-and-management-in-clinical-practice-for-newly-diagn)</sup>\n\n## References\n\n1. [Efficacy and Safety of Daratumumab, Pomalidomide, and Dexamethasone (DPd) Compared to Daratumumab, Bortezomib, and Dexamethasone (DVd) in Daratumumab-Naive Relapsed Multiple Myeloma](https://www.mdpi.com/2072-6694/15/19/4894)\n2. [Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: differential mechanisms of action and recent clinical trial outcomes (Annals of Hematology)](https://link.springer.com/article/10.1007/s00277-022-04917-5)\n3. [DARZALEX (daratumumab) FDA prescribing information](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b)\n4. [DailyMed - DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0)\n5. [Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma (CASTOR)](https://www.nejm.org/doi/full/10.1056/NEJMoa1606038)\n6. [Final analysis of carfilzomib, dexamethasone, and daratumumab vs carfilzomib and dexamethasone in the CANDOR study](https://pmc.ncbi.nlm.nih.gov/articles/PMC10368773/)\n7. [Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma (ALCYONE)](https://www.nejm.org/doi/full/10.1056/NEJMoa1714678)\n8. [Consensus Guidelines for CD38 Monoclonal Antibody-based Quadruplet Therapy in Newly Diagnosed Multiple Myeloma (Pan-Pacific MM Working Group, Clinical Hematology International)](https://chi.scholasticahq.com/article/133682-consensus-guidelines-and-recommendations-for-the-cd38-monoclonal-antibody-based-quadruplet-therapy-and-management-in-clinical-practice-for-newly-diagn)\n9. [Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab](https://pmc.ncbi.nlm.nih.gov/articles/PMC10760401/)\n10. [DARZALEX FASPRO Full Prescribing Information (FDA, 2025)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s035lbl.pdf)\n11. [DARZALEX (IV) Full Prescribing Information](https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf)\n12. [abstract (thelancet.com)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2820%2930734-0/abstract)\n13. [BC Cancer Protocol MYDARCBDF: Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone for previously untreated transplant-ineligible myeloma](https://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Lymphoma-Myeloma/MYDARCBDF_Protocol.pdf)\n14. [haem myel 041 daratumumab sc in combination with bortezomib (d1, 4, 8 & 11) and dexamethasone v4 (kmcc.nhs.uk)](https://www.kmcc.nhs.uk/s3/assets/haem-myel-041-daratumumab-sc-in-combination-with-bortezomib-%28d1,-4,-8-&-11%29-and-dexamethasone-v4.pdf)\n15. [BMP+DARA Regimen (Cancer Care Ontario protocol)](https://www.cancercareontario.ca/en/system/files_force/BMPDARA_HEM_MY_P.pdf?download=1)\n16. [Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS](https://www.nature.com/articles/s41408-023-00805-x)\n17. [Selinexor, daratumumab, bortezomib and dexamethasone for relapsed or refractory multiple myeloma: GEM-SELIBORDARA phase II study](https://haematologica.org/article/view/haematol.2023.284089)\n18. [A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Diagnosed Multiple Myeloma](https://clinicaltrials.gov/study/NCT06169215)\n19. [Multiple myeloma DVd (daratumumab subcutaneous bortezomib dexamethasone) weekly overview | eviQ](https://www.eviq.org.au/haematology/multiple-myeloma/4396-multiple-myeloma-dvd-daratumumab-subcutaneou)\n20. [Janssen (Johnson & Johnson) press release on PERSEUS and CASSIOPEIA data (June 3, 2024)](https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-based-regimens-significantly-improve-clinical-outcomes-in-both-transplant-eligible-and-ineligible-patients-who-are-newly-diagnosed-with-multiple-myeloma)\n21. [Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS trial](https://www.nature.com/articles/s41591-024-03485-7)\n22. [Optimal daratumumab-based regimen for patients with newly diagnosed and previously untreated multiple myeloma: systematic review and component network meta-analysis](https://link.springer.com/article/10.1186/s13643-025-02804-4)\n23. [Daratumumab for the Management of Newly Diagnosed and Relapsed/Refractory Multiple Myeloma: Current and Emerging Treatments](https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.624661/full)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Medicines and therapeutics › Cancer chemotherapy and regimens › Multiple myeloma and hematologic regimens*\n\n*Initially written Sep 29, 2026 · Edited: Oct 15, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n",
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 "speakable": "A daratumumab regimen is a multiple myeloma treatment combining the CD38 antibody daratumumab with backbone drugs such as dexamethasone, bortezomib, or lenalidomide, across newly diagnosed and relapsed disease."
}