A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 55
- 主要终点
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Carfilzomib (Drug)
Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
干预措施: Daratumumab SC (Drug)
Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
干预措施: Talquetamab (Drug)
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.
干预措施: Daratumumab SC (Drug)
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.
干预措施: Talquetamab (Drug)
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.
干预措施: Carfilzomib (Drug)
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.
干预措施: Talquetamab (Drug)
Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
干预措施: Talquetamab (Drug)
Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
干预措施: Lenalidomide (Drug)
Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
干预措施: Lenalidomide (Drug)
Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
干预措施: Talquetamab (Drug)
Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
干预措施: Pomalidomide (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Up to 1 year and 10 months
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.
Number of Participants with AEs by Severity
时间窗: Up to 1 year and 10 months
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.
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
时间窗: Up to 1 year and 6 months
Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
Number of Participants with Dose Limiting Toxicity (DLT)
时间窗: Up to 49 days
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.
次要结局
- Overall Response Rate (ORR)(Up to 1 year and 10 months)
- Very Good Partial Response (VGPR) or Better Response Rate(Up to 1 year and 10 months)
- Complete Response (CR) or Better Response Rate(Up to 1 year and 10 months)
- Stringent Complete Response (sCR)(Up to 1 year and 10 months)
- Duration of Response(Up to 1 year and 10 months)
- Time to Response(Up to 1 year and 10 months)
- Serum Concentration of Talquetamab(Up to 1 year and 10 months)
- Serum Concentration of Daratumumab(Up to 1 year and 10 months)
- Number of Participants with Anti-Drug Antibodies to Talquetamab(Up to 1 year and 10 months)
- Number of Participants with Anti-Drug Antibodies to Daratumumab(Up to 1 year and 10 months)
- Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)(Up to 1 year and 10 months)