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

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.

NCT Number	NCT04140162
Lead Sponsor	University of Michigan Rogel Cancer Center Collaborators: Janssen Scientific Affairs, LLC
Conditions	Multiple Myeloma
Enrollment	57 participants
Start Date	2020-10-05
Primary Completion	2024-05-02 (estimated)
Study Completion	2026-09-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-28