ISRCTN12220131进行中（未招募）3 期
A Phase III 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 one prior line of therapy
Janssen (Netherlands)0 个研究点目标入组 810 人开始时间: 2023年2月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 810
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 20/05/2024:
- •1. Documented multiple myeloma as defined:
- •1.1. Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •1.2. Measurable disease at screening as defined by any of the following:
- •1.2.1. Serum M-protein level =0.5 g/dL (central laboratory)
- •1.2.2. Urine M-protein level =200 mg/24 hours (central laboratory)
- •1.2.3. Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain =10 mg/dL (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •2. Relapsed or refractory disease as defined by:
- •2.1. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment
- •2.2. Refractory disease is defined as less than (<) 25% reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- •3. Received at least one prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only one prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received =2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
- •4. Documented evidence of progressive disease based on the investigator’s determination of response by the IMWG criteria on or after their last regimen
- •5. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- •Previous inclusion criteria:
- •1. Documented multiple myeloma as defined:
- •1.1. Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •1.2. Measurable disease at screening as defined by any of the following:
- •1.2.1. Serum M-protein level =0.5 g/dL (central laboratory)
- •1.2.2. Urine M-protein level =200 mg/24 hours (central laboratory)
- •1.2.3. Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain =10 mg/dL (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •2. Relapsed or refractory disease as defined:
- •2.1. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment
- •2.2. Refractory disease is defined as <25% reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to 60 days after cessation of treatment
- •3. Received at least one prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only one prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received =2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
- •4. Documented evidence
排除标准
- •Current exclusion criteria as of 20/05/2024:
- •1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
- •2. Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
- •3. Received prior pomalidomide therapy
- •4. A maximum cumulative dose of corticosteroids to =140 mg of prednisone or equivalent within the 14-day period before the first dose of the study drug
- •5. 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
- •6. Plasma cell leukaemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
- •Previous exclusion criteria as of 07/11/2023:
- •1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
- •2. Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
- •3. A maximum cumulative dose of corticosteroids to =140 mg of prednisone or equivalent within the 14-day period before the first dose of the study drug
- •4. 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
- •5. Plasma cell leukaemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
- •Previous exclusion criteria:
- •1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
- •2. Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
- •3. A maximum cumulative dose of corticosteroids to =140 mg of prednisone or equivalent within the 14-day period before the first dose of the study drug
- •4. 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
- •5. Plasma cell leukaemia at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
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