Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
| 대상 질환 | Multiple Myeloma |
|---|---|
| 임상 단계 | 2상 |
| 스폰서 | University of Michigan Rogel Cancer Center |
| 상태 | 진행 중(모집 완료) |
| 참여자 수 | 57 명 |
| 중재(약물) | Daratumumab, Lenalidomide, Bortezomib, Dexamethasone |
| 시작일 | 2020년 10월 5일 |
| 완료일 | 2024년 5월 2일 |
| 결과 공개일 | 2026년 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.
| Dara-Rd Followed by Dara-RVd | 15 Participants |
|---|
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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