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 - MonumenTAL-6
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
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
研究者
相似试验
招募中
3 期
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy10018865Multiple MyelomaNL-OMON53729Janssen-Cilag25
招募中
1 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 LenalidomideRelapsed or Refractory MyelomaMedDRA version: 21.1Level: PTClassification code: 10035226Term: Plasma cell myeloma Class: 100000004864CTIS2022-502446-27-00Janssen - Cilag International827
招募中
1 期
A Randomized Study Comparing Talquetamab in Combination WithDaratumumab and Pomalidomide or Talquetamab in Combination WithDaratumumab Versus Daratumumab, Pomalidomide and Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of TherapyMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple MyelomaEUCTR2021-000202-22-NLJanssen-Cilag International NV810
进行中（未招募）
1 期
A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of TherapyRelapsed or Refractory Multiple MyelomaMedDRA version: 21.1Level: PTClassification code: 10035226Term: Plasma cell myeloma Class: 100000004864CTIS2023-503467-41-00Janssen - Cilag International813
进行中（未招募）
1 期
A Randomized Study Comparing Talquetamab in Combination WithDaratumumab and Pomalidomide or Talquetamab in Combination WithDaratumumab Versus Daratumumab, Pomalidomide and Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of TherapyMultiple MyelomaEUCTR2021-000202-22-FRJanssen-Cilag International NV810