An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The rate of achievement of bone marrow minimal residual disease (MRD) negativity
研究概览
简要总结
This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- •Age ≥18 years at the time of consent.
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •Subjects with Multiple Myeloma.
排除标准
- •Active infection requiring systemic therapy or other serious infection within 14 days prior to study treatment.
- •Pregnant or breastfeeding.
研究组 & 干预措施
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Subjects with newly diagnosed multiple myeloma (NDMM) are eligible for standard-of-care autologous stem cell transplantation (ASCT) and receive daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd).
干预措施: Lenalidomide (Drug)
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Subjects with newly diagnosed multiple myeloma (NDMM) are eligible for standard-of-care autologous stem cell transplantation (ASCT) and receive daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd).
干预措施: Daratumumab (Biological)
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Subjects with newly diagnosed multiple myeloma (NDMM) are eligible for standard-of-care autologous stem cell transplantation (ASCT) and receive daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd).
干预措施: Bortezomib (Drug)
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Subjects with newly diagnosed multiple myeloma (NDMM) are eligible for standard-of-care autologous stem cell transplantation (ASCT) and receive daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The rate of achievement of bone marrow minimal residual disease (MRD) negativity
时间窗: At completion of stem cell transplantation (60 days)
The rate of achievement of bone marrow minimal residual disease (MRD) negativity will be defined as the percentage of subjects achieving MRD negativity as determined by next-generation flow cytometry.
次要结局
- Stringent complete response (sCR)(At completion of stem cell transplantation (60 days))
- Therapeutic discontinuation(Up to 2 years)
- Time to best response(Up to 2 years)
- Maximum depth of response (from PR to CR, including sCR)(Up to 2 years)
- Overall response rate (ORR)(Up to 2 years)
- Progression Free Survival (PFS )(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Time to first response(Up to 2 years)