NCT05243797招募中3 期
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,594
- 试验地点
- 399
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
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
- •Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
- •Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
- •Must not be intolerant to the starting dose of lenalidomide.
- •Must not have received any maintenance therapy.
- •Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- •Have clinical laboratory values within prespecified range.
排除标准
- •Received any prior BCMA-directed therapy.
- •Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
- •Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
- •Progressed on multiple myeloma therapy at any time prior to screening.
- •Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
- •Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.
研究组 & 干预措施
Arm A: Teclistamab-Lenalidomide (Tec-Len)
Experimental
Teclistamab will be administered via a subcutaneous injection (SC)
干预措施: Teclistamab (Drug)
Arm B Lenalidomide Alone (Len)
Active Comparator
Lenalidomide orally.
干预措施: Lenalidomide (Drug)
Arm A: Teclistamab-Lenalidomide (Tec-Len)
Experimental
Teclistamab will be administered via a subcutaneous injection (SC)
干预措施: Lenalidomide (Drug)
Arm C Teclistamab-Alone (Tec)
Experimental
Teclistamab will be administered via a subcutaneous injection (SC)
干预措施: Teclistamab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: from randomization to the date of disease progression or death (approximately up to 8 years)
PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD)-negative Complete Response (CR)
时间窗: at month 12
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation flow cytometry (NGF) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy, whichever is earlier, and who also achieve CR of better, according to IMWG criteria.
次要结局
- MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms(baseline up to 8 years)
- PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms(baseline up to week 24)
- Overall Survival (OS)(from the date of from randomization to the date the subject's death, assessed up to 8 years])
- EQ-5D-5L health utility values and the difference between-treatment arms(baseline up to 8 years)
- PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms(baseline up to 8 years)
- Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms(baseline up to 8 years)
- Comparison of efficacy(from randomization to the date of disease progression or death (approximately up to 8 years))
研究者
研究点 (399)
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