drugset / Trial / NCT03224507
Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma
Phase 2
Completed
123 enrolled
University of Alabama at Birmingham
Amgen · collabJanssen Scientific Affairs, LLC · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic malignancy in the U.S. No standard curative therapy has yet been found. A variety of therapeutic measures including high dose melphalan, induction therapy, and continuous therapy have been used but the goal of complete response without relapse has not been achieved. More active treatment regimens and better tools for response assessment are needed.
Timeline
- Start
- 2018-03-14
- Primary completion
- 2023-05-01
- Completion
- 2023-06-30
Publications
- Giri S, Dhakal B, Callander NS, Medvedova E, Godby K, Dholaria BR, Bal S, Ravi G, Chhabra S, Silbermann RW, Costa L. Optimal MRD-based end point to support response-adapted treatment cessation in newly diagnosed multiple myeloma. Blood. 2025 Aug 7;146(6):707-716. doi: 10.1182/blood.2024027674.
- Callander NS, Silbermann R, Kaufman JL, Godby KN, Laubach J, Schmidt TM, Sborov DW, Medvedova E, Reeves B, Dhakal B, Rodriguez C, Chhabra S, Chari A, Bal S, Anderson LD Jr, Dholaria BR, Nathwani N, Hari P, Shah N, Bumma N, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Pei H, Cortoos A, Patel S, Lin TS, Giri S, Costa LJ, Usmani SZ, Richardson PG, Voorhees PM. Daratumumab-based quadruplet therapy for transplant-eligible newly diagnosed multiple myeloma with high cytogenetic risk. Blood Cancer J. 2024 Apr 22;14(1):69. doi: 10.1038/s41408-024-01030-w.
- Costa LJ, Chhabra S, Medvedova E, Dholaria BR, Schmidt TM, Godby KN, Silbermann R, Dhakal B, Bal S, Giri S, D'Souza A, Hall AC, Hardwick P, Omel J, Cornell RF, Hari P, Callander NS. Minimal residual disease response-adapted therapy in newly diagnosed multiple myeloma (MASTER): final report of the multicentre, single-arm, phase 2 trial. Lancet Haematol. 2023 Nov;10(11):e890-e901. doi: 10.1016/S2352-3026(23)00236-3. Epub 2023 Sep 27.
- Costa LJ, Chhabra S, Medvedova E, Dholaria BR, Schmidt TM, Godby KN, Silbermann R, Dhakal B, Bal S, Giri S, D'Souza A, Hall A, Hardwick P, Omel J, Cornell RF, Hari P, Callander NS. Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone With Minimal Residual Disease Response-Adapted Therapy in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2022 Sep 1;40(25):2901-2912. doi: 10.1200/JCO.21.01935. Epub 2021 Dec 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |