drugset / Trial / NCT06353022
Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma
Phase 2
Active not recruiting
103 enrolled
Nantes University Hospital
Janssen Pharmaceutica · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively). The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.
Timeline
- Start
- 2024-06-26
- Primary completion
- 2028-04-26
- Completion
- 2030-06-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Talquetamab | Monoclonal antibody | — | Subcutaneous |
| Subject | Teclistamab | Monoclonal antibody | — | Subcutaneous |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Background | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |