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

2상 진행 중(모집 완료) NCT04140162

대상 질환Multiple Myeloma
임상 단계2상
스폰서University of Michigan Rogel Cancer Center
상태진행 중(모집 완료)
참여자 수57 명
중재(약물)Daratumumab, Lenalidomide, Bortezomib, Dexamethasone
시작일2020년 10월 5일
완료일2024년 5월 2일
결과 공개일2026년 7월 28일

요약

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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