Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy

• Status: Recruiting
• Trial end date: 2025-10-01

Summary

This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy.

This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.

• Phase: Phase 2

Details

• Lead Sponsor: University of Michigan Rogel Cancer Center
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone acetate; Lenalidomide