Talquetamab 与其他抗癌疗法在多发性骨髓瘤患者中的研究 (MonumenTAL-2)
Talquetamab 与其他抗癌疗法在多发性骨髓瘤患者中的多臂 1b 期研究
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Brussels、比利时、1200
- Cliniques Universitaires St-Luc
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Edegem、比利时、2650
- UZA
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Ghent、比利时、9000
- UZ Gent
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Leuven、比利时、3000
- UZ Leuven
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Nantes、法国、44093
- CHU Nantes
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Pessac、法国、33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Rennes、法国、35000
- Chu Rennes Hopital Pontchaillou
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Toulouse、法国、31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Fitzroy、澳大利亚、3065
- St Vincents Hospital Melbourne
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Melbourne、澳大利亚、3004
- Alfred Health
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Southport、澳大利亚、4215
- Gold Coast University Hospital
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Wollongong、澳大利亚、2500
- Wollongong Hospital
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama Birmingham
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California
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San Francisco、California、美国、94143
- University of California San Francisco
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Colorado
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Denver、Colorado、美国、80218
- Colorado Blood Cancer Institute
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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New York
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New York、New York、美国、10065
- Weill Cornell Medical College
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New York、New York、美国、10029
- Mt. Sinai School of Medicine
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North Carolina
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Charlotte、North Carolina、美国、28204
- Levine Cancer Institute
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville、Tennessee、美国、37203
- Tennessee Oncology
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College Of Wisconsin
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London、英国、W1T 7HA
- University College Hospital London
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Manchester、英国、M20 4BX
- The Christie Nhs Foundation Trust
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Oxford、英国、OX3 7LE
- Churchill Hospital
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Surrey、英国、SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Groningen、荷兰、9713 GZ
- UMCG
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Maastricht、荷兰、6229 HX
- Maastricht University Medical Centre
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Utrecht、荷兰、3584 CX
- UMCU
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion Criteria:
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
- History of stroke or seizure within 6 months prior to the first dose of study treatment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment Regimen A: Talquetamab + Carfilzomib
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
Talquetamab will be administered subcutaneously.
其他名称：
Carfilzomib will be administered as an IV infusion. |
|
实验性的：Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
Talquetamab will be administered subcutaneously.
其他名称：
Carfilzomib will be administered as an IV infusion. Daratumumab will be administered subcutaneously. |
|
实验性的：Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
Talquetamab will be administered subcutaneously.
其他名称：
Lenalidomide will be self-administered orally. |
|
实验性的：Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
Talquetamab will be administered subcutaneously.
其他名称：
Daratumumab will be administered subcutaneously. Lenalidomide will be self-administered orally. |
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实验性的：Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
Talquetamab will be administered subcutaneously.
其他名称：
Pomalidomide will be self-administered orally. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
大体时间：Up to 1 year and 10 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 1 year and 10 months
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Number of Participants with AEs by Severity
大体时间：Up to 1 year and 10 months
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. |
Up to 1 year and 10 months
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
大体时间：Up to 1 year and 6 months
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Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. |
Up to 1 year and 6 months
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Number of Participants with Dose Limiting Toxicity (DLT)
大体时间：Up to 49 days
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Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity. |
Up to 49 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Response Rate (ORR)
大体时间：Up to 1 year and 10 months
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ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria. |
Up to 1 year and 10 months
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Very Good Partial Response (VGPR) or Better Response Rate
大体时间：Up to 1 year and 10 months
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VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Complete Response (CR) or Better Response Rate
大体时间：Up to 1 year and 10 months
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CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Stringent Complete Response (sCR)
大体时间：Up to 1 year and 10 months
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sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. |
Up to 1 year and 10 months
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Duration of Response
大体时间：Up to 1 year and 10 months
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Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. |
Up to 1 year and 10 months
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Time to Response
大体时间：Up to 1 year and 10 months
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Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. |
Up to 1 year and 10 months
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Serum Concentration of Talquetamab
大体时间：Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 1 year and 10 months
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Serum Concentration of Daratumumab
大体时间：Up to 1 year and 10 months
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Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Talquetamab
大体时间：Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to talquetamab will be reported. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Daratumumab
大体时间：Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. |
Up to 1 year and 10 months
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Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
大体时间：Up to 1 year and 10 months
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Number of participants with anti-drug antibodies to rHuPH20 will be reported. |
Up to 1 year and 10 months
|
合作者和调查者
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR108946
- 2020-004502-55 (EudraCT编号)
- 64407564MMY1004 (其他标识符：Janssen Research & Development, LLC)
- 2023-503620-60-00 (注册表标识符：EUCT number)
- 2023 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.