BENITIONSClinical Trial Intelligence

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

Phase 2 Active, not recruiting NCT04140162

ConditionMultiple Myeloma
PhasePhase 2
SponsorUniversity of Michigan Rogel Cancer Center
StatusActive, not recruiting
Enrollment57 participants
InterventionsDaratumumab, Lenalidomide, Bortezomib, Dexamethasone
Start dateOct 5, 2020
Completion dateMay 2, 2024
Results postedJul 28, 2026

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.

Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation.

At the end of week 36 (post-consolidation therapy) · Participants

Dara-Rd Followed by Dara-RVd15 Participants

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