Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

Summary

The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

Timeline

Start

2015-02-16

Primary completion

2018-09-24

Completion

2024-10-02

Publications

• Bahlis N, Facon T, San-Miguel J, Usmani SZ, Dimopoulos MA, Moreau P, Zweegman S, Perrot A, Manier S, Chari A, Raje N, Orlowski RZ, Goldschmidt H, Basu S, Hulin C, Weisel K, Mohty M, Leleu X, Plesner T, Jakubowiak A, Cook G, Quach H, Venner CP, Cavo M, Ngo M, Bolyard K, Carson R, Borgsten F, Mateos MV, Kumar SK. Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE. Blood Adv. 2026 Jul 14;10(13):4541-4550. doi: 10.1182/bloodadvances.2025019323.
• Facon T, Moreau P, Weisel K, Goldschmidt H, Usmani SZ, Chari A, Plesner T, Orlowski RZ, Bahlis N, Basu S, Hulin C, Quach H, O'Dwyer M, Perrot A, Jacquet C, Venner CP, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Cook G, Wang G, Pei H, Krevvata M, Carson R, Borgsten F, Kumar SK. Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia. 2025 Apr;39(4):942-950. doi: 10.1038/s41375-024-02505-2. Epub 2025 Feb 27.
• Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, Wang G, Gupta-Werner N, Kaila S, Pei H, Matt K, Gries KS, Carson R, Borgsten F, Weisel K. Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Treated With Daratumumab, Lenalidomide, and Dexamethasone: MAIA Final Analysis of Patient-Reported Outcomes. Eur J Haematol. 2025 May;114(5):883-889. doi: 10.1111/ejh.14392. Epub 2025 Feb 14.
• Moreau P, Facon T, Usmani SZ, Bahlis N, Raje N, Plesner T, Orlowski RZ, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Tiab M, Macro M, Frenzel L, Leleu X, Wang G, Pei H, Krevvata M, Carson R, Borgsten F, Kumar SK. Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: analysis of key subgroups of the MAIA study. Leukemia. 2025 Mar;39(3):710-719. doi: 10.1038/s41375-024-02506-1. Epub 2025 Jan 15.
• Almansour SA, Alqudah MAY, Abuhelwa Z, Al-Shamsi HO, Alhuraiji A, Semreen MH, Bustanji Y, Alzoubi KH, Modi ND, Mckinnon RA, Sorich MJ, Hopkins AM, Abuhelwa AY. Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials. Ther Adv Med Oncol. 2024 Sep 2;16:17588359241275387. doi: 10.1177/17588359241275387. eCollection 2024.
• Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, Perrot A, Weisel K, Raje N, Macro M, Frenzel L, Leleu X, Wang J, Rampelbergh RV, Uhlar CM, Vermeulen J, Duran J, Borgsten F, Usmani SZ. Plain language summary of the MAIA study of daratumumab plus lenalidomide and dexamethasone for the treatment of people with newly diagnosed multiple myeloma. Future Oncol. 2023 Apr;19(13):887-895. doi: 10.2217/fon-2023-0082. Epub 2023 May 22.
• Mateos MV, Rigaudeau S, Basu S, Spicka I, Schots R, Wrobel T, Cook G, Beksac M, Gries KS, Kudva A, Tromp B, Van Rampelbergh R, Pei H, Wroblewski S, Carson R, Delioukina M, White D. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma. J Oncol Pharm Pract. 2023 Jul;29(5):1172-1177. doi: 10.1177/10781552221103551. Epub 2022 Sep 6.
• Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.
• Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.
• San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.
• Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.
• Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.

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Indications