drugset / Trial / NCT04108195
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.
Timeline
- Start
- 2020-02-21
- Primary completion
- 2027-04-07
- Completion
- 2027-04-07
Publications
- Chari A, van de Donk NWCJ, Dholaria B, Weisel K, Mateos MV, Goldschmidt H, Martin TG, Morillo D, Reece D, Rodriguez-Otero P, Bhutani M, D'Souza A, Oriol A, Rosinol L, Bahlis NJ, Vishwamitra D, Skerget S, Verona RI, Bakshi K, Kang L, Prior TJ, Vandenberk L, Tolbert J, Lee S, Smit MD, Wasch R. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025 Dec 11;146(24):2902-2913. doi: 10.1182/blood.2025029360.
- Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | — |
| Subject | Pomalidomide | Other / unclassified | — | — |
| Subject | Talquetamab | Monoclonal antibody | 0.4 mg/kg | Subcutaneous |
| Subject | Talquetamab | Monoclonal antibody | 0.8 mg/kg | Subcutaneous |
| Subject | Teclistamab | Monoclonal antibody | — | — |