Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
Summary
This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists. This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.
Timeline
- Start
- 2026-07
- Primary completion
- 2027-05
- Completion
- 2029-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | Subcutaneous |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Lenalidomide | Other / unclassified | — | Oral |