A Phase 1/2 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 23
- 主要终点
- Phase 1: Number of Participants with Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
- •Participant must have measurable disease defined by any of the following: Serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); Urine M-protein level >= 200 milligrams per 24 hours (mg/24 hours); or Light chain MM, for participants without measurable disease in the serum or urine: serum Ig-free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa-lambda FLC ratio; or if central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25 percent (%)
- •Participant must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory MM or be intolerant to established MM therapies and a candidate for teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitors (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody in any order during the course of treatment. Participants who could not tolerate PI, immunomodulatory drugs, or anti-CD38 antibody are allowed
- •Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study treatment administration
- •Woman of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (beta-human chorionic gonadotropin [beta-hCG]) or urine
排除标准
- •Prior treatment with any B cell maturation antigen (BCMA)-targeted therapy
- •Toxicities from previous anticancer therapies that have not resolved to baseline levels or to less than or equal to (<=) Grade 1 except for alopecia or peripheral neuropathy
- •Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication)
- •Stem cell transplantation: An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease; Received an autologous stem cell transplant less than or equal (<=) 12 weeks before the first step-up dose of study treatment
- •Central nervous system involvement or clinical signs of meningeal involvement of MM. If either is suspected, whole brain magnetic resonance imaging (MRI) and lumbar cytology are required during screening
研究组 & 干预措施
Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM)
Japanese participants will receive Teclistamab subcutaneously (SC) at four dose levels. Cohort 1 will receive Teclistamab at Dose 1 and 2 (step-up doses) prior to first treatment dose on Day 1 followed by Dose 3 weekly (that is, on Days 1,8, and 15 of a 21-day cycle). Cohort 2 will receive Teclistamab at Dose 1 and 4 (step up doses) prior to first treatment dose on Day 1 followed by Dose 5 weekly. Cohort 3 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 6 weekly. Cohort 4 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 7 weekly for (2 cycles), then biweekly (cycle 3 to 6) on Days 1 and 15 and monthly (cycle 7) on Day 1 of 1 28-day cycle. In Phase 2 , participants will receive Teclistamab SC at Dose 1 and 4 (step up doses) up to 8 days prior to first treatment dose on Day 1 followed by Dose 5 on Days 1,8,15, and 22 of a 28-day cycle.
干预措施: Teclistamab (Drug)
结局指标
主要结局
Phase 1: Number of Participants with Serious Adverse Events (SAE)
时间窗: Up to 1 year and 5 months
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)
时间窗: Up to 28 days
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Phase 1: Number of Participants with Adverse Events (AE)
时间窗: Up to 1 year and 5 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore 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.
Phase 2: Overall response rate (ORR)
时间窗: Up to 1 year and 5 months
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the 2016 International Myeloma Working Group (IMWG) response criteria.
次要结局
- Phase 2: Number of Participants with SAEs by Severity(Up to 1 year and 5 months)
- Phase 2: 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) Score(Up to 1 year and 5 months)
- Phase 1 and Phase 2: Serum Concentration of Teclistamab(Up to 1 year and 5 months)
- Phase 1: Systemic Cytokine Concentrations(Up to 1 year and 5 months)
- Phase 1 and Phase 2: Number of Participants with Anti-teclistamab Antibodies(Up to 1 year and 5 months)
- Phase 1: Objective Response Rate(Up to 1 year and 5 months)
- Phase 2: Change from Baseline in EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) Scale(Up to 1 year and 5 months)
- Phase 2: Overall survival (OS)(Up to 1 year and 5 months)
- Phase 2: Minimal Residual Disease (MRD)-negative Rate(Up to 1 year and 5 months)
- Phase 2: Number of Participants with AEs(Up to 1 year and 5 months)
- Phase 2: Number of Participants with AEs by Severity(Up to 1 year and 5 months)
- Phase 2: Number of Participants with SAEs(Up to 1 year and 5 months)
- Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values(Up to 1 year and 5 months)
- Phase 1 and Phase 2: Duration of Response (DOR)(Up to 1 year and 5 months)
- Phase 1 and Phase 2: Time to Response (TTR)(Up to 1 year and 5 months)
- Phase 2: Very Good Partial Response (VGPR) or Better Response Rate (Stringent Complete Response [sCR]+ Complete Response [CR]+VGPR)(Up to 1 year and 5 months)
- Phase 2: Complete Response (CR) or Better Response Rate(Up to 1 year and 5 months)
- Phase 2: Stringent Complete Response (sCR) Rate(Up to 1 year and 5 months)
- Phase 2: Progression-free Survival (PFS)(Up to 1 year and 5 months)
- Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values by Severity(Up to 1 year and 5 months)
- Phase 2: Change from Baseline in Patient Global Impression of Severity (PGIS) Scale(Up to 1 year and 5 months)