NCT07099391 A Study of Dara-RVd and Teclistamab-RVd in People With Multiple Myeloma
| NCT ID | NCT07099391 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2025-07-24 |
| Primary Completion | 2029-07-24 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to find out whether Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone) after 3 treatment Cycles of Dara-RVd (daratumumab, lenalidomide, bortezomib, and dexamethasone) is a safe treatment for people with newly diagnosed multiple myeloma (MM).
Eligibility Criteria
Inclusion Criteria: 1. Documented multiple myeloma satisfying the International Myeloma Working Group (IMWG) diagnostic criteria36 (evidence of myeloma defining event attributed to underlying plasma cell disorder) with measurable disease defined as: 1. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma 2. Measurable disease within the past 4 weeks defined by any of the following: * IgG myeloma: Serum monoclonal protein ≥ 1.0 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or * IgA, IgM, IgD, IgE multiple myeloma: serum M-protein ≥ 0.5 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or * Light chain multiple myeloma: Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum free kappa/lambda light chain ratio * Measurable plasmacytomas seen on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm). If this is the primary marker of measurable disease, patients will need a biopsy at screening. * Bone marrow plasma cells ≥ 30% as d