NCT05160584招募中不适用
A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
Janssen Pharmaceutica N.V., Belgium153 个研究点 分布在 9 个国家目标入组 300 人开始时间: 2021年11月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 153
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
- •For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or
- •For Period 3: Have ECOG performance status of 0,1 or 2
- •For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
- •For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
- •For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
- •For Period 1 and 2: Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible
- •For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
- •Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
- •For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain >= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (>=1 lesion has 2 diameters >= 1 centimeter [cm])
排除标准
- 未提供
研究组 & 干预措施
Participants with Relapsed/Refractory Multiple Myeloma
Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.
干预措施: No intervention (Other)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 52 months
Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).
次要结局
- Very Good Partial Response (VGPR) Rate(Up to 52 months)
- Time to Response (TTR)(Up to 52 months)
- Complete Response (CR) Rate(Up to 52 months)
- Minimal Residual Disease (MRD) Negative Rate(Up to 52 months)
- Stringent Complete Response (sCR) Rate(Up to 52 months)
- Clinical Benefit Rate (CBR)(Up to 52 months)
- Duration of Response (DOR)(Up to 52 months)
- Time to Best Response(Up to 52 months)
- Time to Next Treatment (TTNT)(Up to 52 months)
- Progression-free Survival (PFS)(Up to 52 months)
- Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)(Up to 52 months)
- Overall Survival (OS)(Up to 52 months)
- Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score(Baseline up to 52 months)
- Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)(Baseline up to 52 months)
- Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39(Baseline up to 52 months)
- Number of Participants with Adverse Events (AEs)(Up to 52 months)
- Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)(Up to 52 months)
- Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Up to 52 months)
- Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)(Up to 52 months)
- Period 3: Percentage of Participants with Overall Response to Subsequent Therapies(Up to 52 months)
研究者
研究点 (153)
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