CTIS2022-500861-29-00招募中1 期
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2 - CA057-008
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 493
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participant has documented diagnosis of multiple myeloma (MM) and measurable disease, defined as any of the following: a.M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP) or b.M-protein = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, c.For participants without measurable disease in sPEP or uPEP: sFLC levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal ?/? FLC ratio., Participant has received at least 1 prior line of anti-myeloma therapy., Participant must have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody., Participant achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy., Participant must have documented disease progression during or after their last anti-myeloma regimen., Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
排除标准
- •Participant who has had prior treatment with mezigdomide or carfilzomib., Participant who has had any investigational agents within 28 days or 5 half-lives (whichever is shorter) of initiating study intervention., Participant has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study intervention., Participant with known central nervous system (CNS) involvement with myeloma., Participant has any of the following laboratory abnormalities: i) Absolute neutrophil count (ANC) < 1,000/µL. It is not permissible to administer GCSF to achieve minimum ANC levels within 7 days prior to the complete blood count (CBC), which will be used to determine eligibility (or within 14 days prior for pegfilgrastim). ii) Platelet count: < 75,000/µL for participants in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for participants in whom = 50% of bone marrow nucleated cells are plasma cells. Platelet transfusions are not permitted within 7 days prior to the complete blood count (CBC), which will be used to determine eligibility. iii) Not applicable per Protocol Amendment 02. iv) Estimated glomerular filtration rate (eGFR) < 30 mL/min or requiring dialysis. eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) formula (see Appendix 8). v) Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) vi) Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5× upper limit of normal (ULN) vii) Serum total bilirubin > 1.5× ULN; < 3.0 mg/dL is allowed for participants with documented Gilbert’s syndrome., Participant with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may significantly alter the absorption of mezigdomide and/or other oral study intervention., Participant has prior history of malignancies, other than MM, unless the participant has been free of the disease for = 5 years with the exception of certain noninvasive malignancies., Participant has impaired cardiac function or clinically significant cardiac disease, including any of the following: a.Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure New York Heart Association Class III-IV) or pericardial disease. b.Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities, including prolongation of QT interval on Screening ECG as defined by a QTc interval > 470 msec using Fridericia’s QT correction formula. c.Left ventricular ejection fraction < 40% as assessed by transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA).
研究者
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