A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 111
- 主要终点
- Part 1: Number of participants with dose limiting toxicity (DLT)
研究概览
简要总结
The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide.
There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma.
Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement.
All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle.
Participants will receive study medicine until:
- their disease progresses or,
- they experience unacceptable side effects or,
- they choose to no longer take part in the study.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Prior diagnosis of multiple myeloma as defined by IMWG criteria
- •Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- •Serum M-protein ≥0.5 g/dL by SPEP
- •Urinary M-protein excretion ≥200 mg/24 hour by UPEP
- •Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65)
- •Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
- •Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
- •ECOG performance status 0-1
- •Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
排除标准
- •Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
- •Impaired cardiovascular function or clinically significant cardiovascular diseases
- •Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- •Participants with any active, uncontrolled bacterial, fungal, or viral infection
- •Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- •Previous treatment with:
- •BCMA-directed or CD3 redirecting therapy
- •Iberdomide (CC-220) or Mezigdomide
- •Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
- •Administration with an investigational product within 30 days preceding the first dose of study intervention
- •Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
研究组 & 干预措施
Part 1 Dose Escalation
Non-randomized elranatamab plus iberdomide
干预措施: Elranatamab (Drug)
Part 2 Dose Randomization
Randomized elranatamab plus iberdomide
干预措施: Elranatamab (Drug)
Part 2 Dose Randomization
Randomized elranatamab plus iberdomide
干预措施: Iberdomide (Drug)
Part 1 Dose Escalation
Non-randomized elranatamab plus iberdomide
干预措施: Iberdomide (Drug)
结局指标
主要结局
Part 1: Number of participants with dose limiting toxicity (DLT)
时间窗: Cycle 1, about 28 days
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants
Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
时间窗: Assessed from baseline up to 90 days after last dose of study treatment
Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.
次要结局
- Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)(Assessed for approximately 2 years)
- Part 1 and Part 2: Time to Response (TTR)(Assessed for approximately 2 years)
- Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities(Assessed from baseline up to 90 days after last dose of study treatment)
- Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)(Assessed for approximately 2 years)
- Part 1 and Part 2: Duration of Complete Response (DOCR)(Assessed for approximately 2 years)
- Part 1 and Part 2: Concentrations of elranatamab(Assessed for approximately 2 years)
- Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment(Assessed from baseline up to 90 days after last dose of study treatment)
- Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity(Assessed from baseline up to 90 days after last dose of study treatment)
- Part 1 and Part 2: Time of Overall Survival (OS)(Assessed for approximately 2 years)
- Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate(Assessed for approximately 2 years)
- Part 1 and Part 2: Concentrations of iberdomide(Assessed for approximately 4 months)
- Part 1 and Part 2: Time of Progression Free Survival (PFS)(Assessed for approximately 2 years)
- Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab(Assessed for approximately 2 years)
- Part 1 and Part 2: Duration of Response (DOR)(Assessed for approximately 2 years)