A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Biocad
- 入组人数
- 252
- 试验地点
- 14
- 主要终点
- Overall response rate according to IMWG (International Myeloma Working Group) criteria
研究概览
简要总结
The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed consent form.
- •Age ≥ 18 years at the time of signing of the informed consent form.
- •Documented diagnosis of multiple myeloma according to IMWG criteria
- •Measurable disease at screening:
- •M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
- •light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio .
- •At least a partial response according to IMWG criteria to at least 1 prior line of therapy.
- •Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy
- •ECOG score 0-
- •Not pregnant and willing to use contraception.
- •Consent to bone marrow biopsy in the study.
排除标准
- •Prior treatment with daratumumab or other anti-CD38 therapy.
- •Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
- •Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
- •Allogeneic hematopoietic stem cell transplantation, regardless of timing.
- •Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
- •Plasma cell leukemia, POEMS syndrome or amyloidosis.
- •Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement.
- •A history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the Investigator's opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years.
- •Plasmapheresis within 28 days prior to randomization.
- •Clinical signs of meningeal involvement of multiple myeloma.
- •Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab.
研究组 & 干预措施
BCD-264
Blinded period: BCD-264 (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.
Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks
干预措施: BCD-264 (Drug)
Darzalex
Blinded period: Darzalex (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.
Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks
干预措施: Darzalex (Drug)
结局指标
主要结局
Overall response rate according to IMWG (International Myeloma Working Group) criteria
时间窗: up to 24 weeks
次要结局
- Duration of response(up to 3 years)
- Progression-free survival(up to 3 years)
- Time to response(up to 3 years)
- Stringent complete response rate according to IMWG criteria(up to 3 years)
- Complete response (CR) rate according to IMWG criteria(up to 3 years)
- Very good partial response (VGPR) rate according to IMWG criteria(up to 3 years)
- Time to progression(up to 3 years)
- Overall survival(up to 3 years)