A Multi-arm Phase 1b Study of Teclistamab 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
- 140
- 试验地点
- 27
- 主要终点
- Number of Participants with Abnormalities in Laboratory Values
研究概览
简要总结
The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
- •Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- •A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment
排除标准
- •Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
- •Live, attenuated vaccine within 30 days 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
研究组 & 干预措施
Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Participants will receive teclistamab plus daratumumab plus pomalidomide.
干预措施: Teclistamab (Drug)
Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Participants will receive teclistamab plus daratumumab plus pomalidomide.
干预措施: Daratumumab (Drug)
Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Participants will receive teclistamab plus daratumumab plus pomalidomide.
干预措施: Pomalidomide (Drug)
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
干预措施: Teclistamab (Drug)
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
干预措施: Daratumumab (Drug)
Treatment Regimen C: Teclistamab + Nirogacestat
Participants will receive teclistamab plus nirogacestat.
干预措施: Teclistamab (Drug)
Treatment Regimen D: Teclistamab + Lenalidomide
Participants will receive teclistamab plus lenalidomide.
干预措施: Teclistamab (Drug)
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
干预措施: Lenalidomide (Drug)
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
干预措施: Bortezomib (Drug)
Treatment Regimen C: Teclistamab + Nirogacestat
Participants will receive teclistamab plus nirogacestat.
干预措施: Nirogacestat (Drug)
Treatment Regimen D: Teclistamab + Lenalidomide
Participants will receive teclistamab plus lenalidomide.
干预措施: Lenalidomide (Drug)
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
Participants will receive teclistamab plus daratumumab plus lenalidomide.
干预措施: Lenalidomide (Drug)
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
干预措施: Teclistamab (Drug)
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
Participants will receive teclistamab plus daratumumab plus lenalidomide.
干预措施: Teclistamab (Drug)
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
Participants will receive teclistamab plus daratumumab plus lenalidomide.
干预措施: Daratumumab (Drug)
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
干预措施: Daratumumab (Drug)
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
干预措施: Lenalidomide (Drug)
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Number of Participants with Abnormalities in Laboratory Values
时间窗: Up to 2 year and 5 months
Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Number of Participants with Dose-Limiting Toxicity (DLT)
时间窗: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Number of Participants with Incidence of Adverse Events (AEs)
时间窗: Up to 2 year and 5 months
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of Participants with AEs by Severity
时间窗: Up to 2 year and 5 months
Number of participants with AEs by severity will be reported.
次要结局
- Complete Response (CR) or Better Response Rate(Up to 2 year and 5 months)
- Stringent Complete Response (sCR) Rate(Up to 2 year and 5 months)
- Overall Response Rate (ORR)(Up to 2 year and 5 months)
- Duration of Response(Up to 2 year and 5 months)
- Time to Response(Up to 2 year and 5 months)
- Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab(Up to 2 year and 5 months)
- Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab(Up to 2 year and 5 months)
- Very Good Partial Response (VGPR) or Better Response Rate(Up to 2 year and 5 months)
- Serum Concentrations of Teclistamab(Up to 2 year and 5 months)
- Serum Concentrations of Nirogacestat(Up to 2 year and 5 months)
- Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)(Up to 2 year and 5 months)
- Serum Concentrations of Daratumumab(Up to 2 year and 5 months)