NCT05317416进行中（未招募）3 期
A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 854
- 试验地点
- 347
- 主要终点
- Minimal Residual Disease negativity rate
研究概览
简要总结
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
详细描述
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
- •Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
- •History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
- •Partial Response or better according to IMWG criteria at the time of randomization
- •Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
- •ECOG performance status ≤1
- •Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
- •Not pregnant and willing to use contraception
排除标准
- •Plasma cell leukemia
- •Amyloidosis, Waldenström's macroglobulinemia
- •POEMS syndrome
- •Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- •Previous MM maintenance treatment
- •Prior treatment with BCMA targeted therapy
- •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
- •Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
- •Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
研究组 & 干预措施
Arm B - Part 2
Active Comparator
Lenalidomide
干预措施: Lenalidomide (Drug)
Arm C - Part 2
Experimental
Elranatamab
干预措施: Elranatamab (Drug)
Arm A - Part 1
Experimental
Elranatamab
干预措施: Elranatamab (Drug)
Arm B - Part 1
Active Comparator
Lenalidomide
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Minimal Residual Disease negativity rate
时间窗: 12 months after randomization
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Progression Free Survival
时间窗: Assessed for up to approximately 5 years
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
次要结局
- Minimal residual disease Negative rate(12 months after randomization)
- Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants(Assessed up to approximately 5 years)
- PFS by BICR per IMWG in IMWG 2025 standard-risk participant(Assessed up to approximately 5 years)
- MRD-negative rate per IMWG 2025(12 months after randomization)
- Overall Survival(Assessed for up to approximately 5 years)
- Sustained MRD negative rate(24 months after randomization)
- Progression Free Survival(Assessed for up to approximately 5 years)
- Overall minimal residual disease negative rate(Assessed for up to approximately 5 years)
- Duration of minimal residual disease negativity(Assessed for up to approximately 5 years)
- Sustained minimal residual disease negativity rate(Assessed for up to approximately 5 years)
- Complete response rate(Assessed for up to approximately 5 years)
- Duration of complete response(Assessed for up to approximately 5 years)
- Frequency of adverse events(Up to 90 days after last dose)
- Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome(Assessed for up to approximately 5 years)
- Frequency of laboratory abnormalities(Assessed for up to approximately 5 years)
- Pre-dose concentrations of elranatamab(Assessed for up to approximately 5 years)
- Post-dose concentrations of elranatamab(Assessed for up to approximately 5 years)
- Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab(Assessed for up to approximately 5 years)
- Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30(Assessed for up to approximately 5 years)
- Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20(Assessed for up to approximately 5 years)
- Progression Free Survival 2(Assessed for up to approximately 5 years)
研究者
研究点 (347)
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