NCT02874742已完成2 期
Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Percentage of Participants With Stringent Complete Response (sCR)
研究概览
简要总结
The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR), as defined by the International Myeloma Working Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Considered by the investigator to be eligible for high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT) according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory studies
- •Has not had prior systemic therapy for multiple myeloma. An emergency course of steroids (defined as no greater than 40 milligram [mg] of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •Woman of childbearing potential must have 2 negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) during screening, the first one within 10 to 14 days prior to the first dose of any component of study treatment and the second within 24 hours prior to the first dose of any component of study treatment
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (including during dose interruptions), and for 4 weeks following discontinuation of lenalidomide, and if receiving daratumumab, for 3 months after the last dose
排除标准
- •Diagnosed or treated for malignancy other than multiple myeloma, except: a) Malignancy treated with curative intent and with no known active disease present for more than equal to (>= )3 years before randomization; b) Adequately treated non-melanoma skin cancer, lentigo maligna or in situ malignancies (including but not limited to, cervical, breast) with no evidence of disease
- •Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma
- •Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) less than (<)50 percent (%) of predicted normal
- •Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
- •Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C. Participants who completed treatment for hepatitis C at least 6 months prior to screening and have no detectable circulating hepatitis C virus (HCV) at screening, may participate in the study. Such participants will be required to undergo regular assessment for HCV reactivation during their participation in the study. Participants who test positive for HCV at any time during these assessments will be withdrawn from the study
研究组 & 干预措施
Lenalidomide+Bortezomib+Dexamethasone (RVd)
Experimental
Participants will receive lenalidomide, bortezomib and dexamethasone.
干预措施: Lenalidomide (Drug)
Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd)
Experimental
Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab.
干预措施: Lenalidomide (Drug)
Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd)
Experimental
Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab.
干预措施: Bortezomib (Drug)
Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd)
Experimental
Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab.
干预措施: Dexamethasone (Drug)
Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd)
Experimental
Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab.
干预措施: Daratumumab (Drug)
Lenalidomide+Bortezomib+Dexamethasone (RVd)
Experimental
Participants will receive lenalidomide, bortezomib and dexamethasone.
干预措施: Bortezomib (Drug)
Lenalidomide+Bortezomib+Dexamethasone (RVd)
Experimental
Participants will receive lenalidomide, bortezomib and dexamethasone.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Percentage of Participants With Stringent Complete Response (sCR)
时间窗: From randomization to post-ASCT consolidation (after Cycle 6) before maintenance treatment (up to 10 months)
Percentage of participants who had achieved sCR as determined by the validated computer algorithm according to the International Myeloma Working Group (IMWG) criteria, by the end of post-autologous stem cell transplantation (post-ASCT) consolidation treatment were reported. Complete response (CR) is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.
次要结局
- Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better(From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance period of 24 months (overall duration up to 34 months))
- Duration of Stringent Complete Response (sCR)(From randomization to the date of first documented evidence of progressive disease or relapse from sCR (up to 5 years))
- Time to Stringent Complete Response (sCR)(From randomization to the date of initial documentation of sCR (up to 5 years))
- Time to Progression (TTP)(From randomization to the date of first documented evidence of progressive disease (up to 5 years))
- Overall Survival (OS)(From randomization to the date of initial documentation of participant's death (up to 5 years))
- Time to Complete Response or Better(From randomization to the date of initial documentation of CR (up to 5 years))
- Time to Partial Response (PR) or Better(From randomization to the date of initial documentation of PR or better (up to 5 years))
- Percentage of Participants With Complete Response (CR) or Better(From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance period of 24 months (overall duration up to 34 months))
- Percentage of Participants With Overall Stringent Complete Response (sCR)(From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance treatment of 24 months (overall duration up to 34 months))
- Percentage of Participants With Negative Minimal Residual Disease (MRD)(From randomization to end of following: induction treatment, post-ASCT consolidation (after Cycle 6) (up to 4.5 months), and at the end of maintenance period of 24 months (overall duration up to 34 months))
- Duration of Complete Response or Better(From randomization to the date of first documented evidence of progressive disease or relapse from CR (up to 5 years))
- Time to Very Good Partial Response (VGPR) or Better(From randomization to the date of initial documentation of VGPR or better (up to 5 years))
- Progression-free Survival (PFS)(From randomization to the date of first documented evidence of progressive disease or death (up to 5 years))
- Percentage of Participants With Overall Response Rate (ORR)(From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance treatment of 24 months (overall duration up to 34 months))
- Duration of Response(From the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive (up to 5 years))
研究者
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