drugset / Trial / NCT06974786
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
Phase 2
Recruiting
100 enrolled
SCRI Development Innovations, LLC
Pfizer · collabcoMMit, Myeloma Trials, Innovated · collab
RandomizedSequentialOpen-labelTreatment
Summary
This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).
Timeline
- Start
- 2025-08-08
- Primary completion
- 2032-11
- Completion
- 2033-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elranatamab | Monoclonal antibody | — | Subcutaneous |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Background | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |