A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 81
- 主要终点
- Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line
- •Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
- •Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
- •A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
排除标准
- •Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
- •Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- •Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
- •Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required
- •Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study
研究组 & 干预措施
Arm B: Post-change Teclistamab
Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to DA-LTE phase to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary.
干预措施: Teclistamab (Drug)
Arm A: Pre-change Teclistamab
Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to Drug Access Long-term Extension (DA-LTE) phase and will continue to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary.
干预措施: Teclistamab (Drug)
结局指标
主要结局
Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose
时间窗: Cycle 1 (28 days cycle): Predose to Day 7 postdose
AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).
Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1
时间窗: Cycle 3 (28 days cycle): Day 1
Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.
Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab
时间窗: Cycle 1 (28 days cycle): Predose to Day 7 postdose
Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).
次要结局
- Number of Participants with Anti-drug Antibodies (ADAs)(Up to approximately 3 years)
- Percentage of Participants With Complete Response (CR) or Better Response(Up to approximately 3 years)
- Number of Participants with Adverse Events (AEs) by Severity(Up to approximately 3 years)
- Number of Participants with Serious Adverse Events (SAEs)(Up to approximately 3 years)
- Number of Participants with Abnormal Laboratory Results(Up to approximately 3 years)
- Percentage of Participants With Overall Response (Partial Response [PR] or Better)(Up to approximately 3 years)
- Percentage of Participants With Very Good Partial Response (VGPR) or Better Response(Up to approximately 3 years)