2022-501515-14-00招募中3 期
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 464
- 试验地点
- 91
- 主要终点
- PFS, defined as the time from randomization to the first documentation of progressive disease according to International Myeloma Working Group (IMWG) Uniform Response Criteria for MM or death due to any cause, whichever occurs first
研究概览
简要总结
To compare the efficacy of iberdomide to that of lenalidomide in participants with NDMM after ASCT, as measured by PFS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •At the time of diagnosis: Participants with confirmed diagnosis of symptomatic MM, defined as monoclonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy-proven plasmacytoma and documented MM satisfying at least 1 of the myeloma-defining events as detailed in the IMWG criteria for the diagnosis of myeloma.
- •At enrollment: Eastern Cooperative Oncology Group performance status performance status score of 0, 1, or
- •Participant has received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory compound (IMiD) with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide and dexamethasone and followed by a single or tandem ASCT. Post-stem cell transplant consolidation is permitted. Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction who achieved at least a partial response after ASCT with or without consolidation, according to IMWG 2016 criteria.
- •For participants who have not received consolidation therapy, the participant must be within 120 days of the last transplant at the time of randomization.
- •For participants treated with consolidation therapy, the participant must be within 30-60 days of the last dose of consolidation therapy at the time of randomization and within 180 days of the last transplant at the time of randomization.
排除标准
- •Participant has progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT or is not responsive to primary therapy.
- •Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities (POEMS syndrome); or Waldenstrom’s macroglobulinemia.
- •Participant has smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- •Participant has known central nervous system/meningeal involvement of MM.
- •Participant has any of the following laboratory test result abnormalities: absolute neutrophil count < 1,000/μL; Platelet count: < 75,000/μL; Hemoglobin < 8 g/dL (<4.9 mmol/L; Creatinine clearance < 30 mL/min or requiring dialysis; Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L); Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal (ULN) or serum total bilirubin > 1.5 × ULN.
- •Peripheral neuropathy of Grade ≥
- •Received any prior B-cell maturation antigen directed therapy.
- •Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells).
结局指标
主要结局
PFS, defined as the time from randomization to the first documentation of progressive disease according to International Myeloma Working Group (IMWG) Uniform Response Criteria for MM or death due to any cause, whichever occurs first
PFS, defined as the time from randomization to the first documentation of progressive disease according to International Myeloma Working Group (IMWG) Uniform Response Criteria for MM or death due to any cause, whichever occurs first
次要结局
- Achieving MRD negativity (at a threshold of 10–5 by next-generation flow) in participants who are in a response of CR or better at 12 (±3) months post start of maintenance treatmen
- OS, defined as the time from randomization to deathdue to any cause
- Recommended iberdomide dose for Stage 2
- PK of iberdomide
- Safety (type, frequency, seriousness, and severity of AEs), and relationship of AEs to study treatment
- PFS2 is defined as the time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first
- Achieving MRD negativity (at a threshold of 10-5 by next-generation flow) in participants with a response of CR or better at any time after the date of randomization
- Conversion from MRD-positive to MRD-negative in participants with a response of CR or better (at a threshold of 10-5 by next-generation flow)
- Achievement of a response of CR or better and maintaining MRD-negative status (at a threshold of 10-5 by next-generation flow) in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments
- TTP, defined as the time from randomization to the first documentation of disease progression according to IMWG Uniform Response Criteria for MM
- TTNT is defined as the time from randomization to the start of the participant receiving any anti myeloma treatment other than study treatment
- Best response achieved (including VGPR, CR, and sCR) prior to PD
- Subscale and total scores in patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30, EORTC QLQ-MY20
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (91)
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