CTIS2024-514139-50-00招募中1 期
C1071006 – An Open-Label, 2-Arm, Multicenter, Randomized Phase 3 Study To Evaluate The Efficacy And Safety of Elranatamab (PF-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone in Transplant-Ineligible Participants With Newly-Diagnosed Multiple Myeloma - C1071006
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 1,090
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
- •Participants must meet the following inclusion criteria to be eligible for enrollment into the study. Criteria are for both Part 1 and Part 2 unless otherwise specified: Age and Sex:Participant's age =18 years (or the minimum country specific age of consent if >18) at Visit 1 (Screening)., Part 2 only: Participant has NDMM and is transplant-ineligible as defined by age =65 years or is transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant., Eastern Cooperative Oncology Group (ECOG) performance status =2., Adequate hepatic, renal, and bone marrow (BM) function (absolute neutrophil count [ANC], platelet count, hemoglobin)., Corrected serum calcium =14 mg/dL (=3.5 mmol/L), or free ionized calcium =6.5 mg/dL (=1.6 mmol/L)., Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1., Type of Participant and Disease Characteristics: Diagnosis of multiple myeloma (MM) as defined according to IMWG criteria., Measurable disease based on IMWG criteria as defined by at least 1 of the following (as assessed by the central laboratory for Part 2), Serum M-protein =0.5 g/dL, Involved free light chain (FLC) =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)., Part 1 only: Participant with NDMM or RRMM. NDMM participant must be transplant-ineligible as defined by age =65 years or transplantineligible as defined by age <65 years with comorbidities impacting the possibility of transplant. Participants with RRMM must have received 1-2 prior lines of MM therapy including at least one immunomodulatory drug (IMiD) and one proteasome inhibitor (PI).
排除标准
- •Medical Conditions: Smoldering MM., Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator., Participants with known or suspected hypersensitivity to the study interventions or any of their excipients., Participants with known or suspected central nervous system (CNS) or clinical signs of myelomatous meningeal involvement., Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study., Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed (assuming no drug interaction potential)., Monoclonal gammopathy of undetermined significance (MGUS)., Plasma cell leukemia., Waldenströms Macroglobulinemia., Systemic light chain amyloidosis., Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities (POEMS) Syndrome., Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment., Ongoing Grade 3 or higher peripheral sensory or motor neuropathy, history of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade >3 peripheral motor polyneuropathy., Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) coronavirus disease 2019 (COVID-19)/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. Active infections must be resolved at least 21 days prior to enrollment. Participants treated with systemic anti-infective agents within 28 days prior to enrollment are not eligible. Prophylactic use of systemic agents is permitted.
研究者
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