CTRI/2024/02/063266招募中3 期
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 795
- 试验地点
- 3
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Documented multiple myeloma as defined by the criteria below: a. multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria b. measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to greater than equal to 0.5 gram per deciliter; or (ii) urine M-protein level greater than equal 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain (FLC) greater than equal 10 milligrams per deciliter and abnormal serum Ig kappa lambda FLC ratio -Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than 60 days after cessation of treatment. b) Refractory disease is defined as less than 25 percent reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to 60 days after cessation of treatment.
- •Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen- Have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment -A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment.
排除标准
- •Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- •Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF).
- •Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- •A maximum cumulative dose of corticosteroids of greater than equal 140 mg of prednisone or equivalent within 14-day period before the first dose of study drug.
- •Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 7 years 2 months
次要结局
- Overall Response Rate (ORR)(Up to 7 years 2 months)
- Complete Response (CR) or Better Rate(Up to 7 years 2 months)
- Very Good Partial Response (VGPR) or Better Rate(Up to 7 years 2 months)
- Minimal Residual Disease (MRD)-negative CR Rate(Up to 7 years 2 months)
- Overall Survival (OS)(Up to 7 years 2 months)
- Progression Free Survival on Next-line Therapy (PFS2)(Up to 7 years 2 months)
- Time to Next Treatment (TTNT)(Up to 7 years 2 months)
- Serum Concentration of Talquetamab and Teclistamab(p to 7 years 2 months)
- Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab(Up to 7 years 2 months)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)(Up to 7 years 2 months)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30(Up to 7 years 2 months)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)(Up to 7 years 2 months)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression –Severity (PGI-S)(Up to 7 years 2 months)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey(Up to 7 years 2 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q(Up to 7 years 2 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30(Up to 7 years 2 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L(Up to 7 years 2 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S(Up to 7 years 2 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste SurveyChange from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey(Up to 7 years 2 months)
- Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30(Up to 7 years 2 months)
研究者
Dr Sanish Davis
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
研究点 (3)
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