2024-514990-23-00已完成2 期
Phase 1/2 trial evaluating isatuximab in combination with pegenzileukin in relapsed or refractory multiple myeloma (RRMM) previously exposed to anti-CD38 and anti-BCMA
Sanofi-Aventis Recherche & Developpement12 个研究点 分布在 6 个国家目标入组 27 人开始时间: 2023年9月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 12
- 主要终点
- Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab
研究概览
简要总结
• Part 1 (dose finding, experimental substudies): -To determine or confirm the recommended dose of novel agents when combined with isatuximab with or without dexamethasone in participants with RRMM. • Part 2 (expansion, independent experimental substudies): -To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of overall response rate (ORR).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 years of age inclusive or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line).
- •RRMM with measurable disease: Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- •RRMM with measurable disease: Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- •RRMM with measurable disease: Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio <0.26 or >1.65).
- •Men or woman or childbearing potential should agree to use contraception.
- •Substudy 04: Anti-CD38 and anti-B cell maturation antigen (BCMA) therapy (if available) prior exposed participants with RRMM. For anti-CD38, “Exposure” is defined as at least 2 cycles of therapy. For anti-BCMA therapy if available, exposure is defined by at least 2 cycles of therapy.
排除标准
- •Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
- •Participants with a contraindication to treatment.
- •Vaccination with a live vaccine 4 weeks before the start of the study.
- •Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- •Hemoglobin <8 g/dL.
- •Platelets <50 × 10^9/L
- •Absolute neutrophil count <1.0 × 10^9/L
- •Creatinine clearance <30 mL/min/1.73m
- •Total bilirubin >1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN.
- •Aspartate aminotransferase and/or alanine aminotransferase >3 × ULN.
- •Patients with grade 3 or 4 hypercalcemia.
- •Uncontrolled infection within 14 days prior to first study intervention administration.
- •Substudy 04:Central nervous system or leptomeningeal disease
- •Substudy 04:Medical history of seizure.
- •Substudy 04:Participants currently receiving hepatically metabolized narrow therapeutic index drugs (eg, digoxin, warfarin) if cannot be closely monitored.
- •Substudy 04:Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), except controlled by replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc). The following are not exclusionary: vitiligo, childhood asthma that has resolved, psoriasis that does not require systemic treatment.
- •Substudy 04:Prior allogeneic hematopoietic stem cell transplant (allo-HSCT).
- •Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg, myocardial infarction, unstable angina, coronary (eg, coronary artery bypass graft, percutaneous coronary intervention) or peripheral artery revascularization, left ventricular ejection fraction <40%, heart failure New York Heart Association Classes III and IV, stroke, transient ischemic attack, pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0).
- •Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A
- •Uncontrolled or active hepatitis B virus (HBV) infection.
- •Active hepatitis C virus (HCV) infection.
- •Any of the following within 3 months prior to first study intervention administration: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease.
- •Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma, unless they are successfully treated with curative intent for more than 3 years before first study intervention administration.
- •Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone.
研究组 & 干预措施
PEGENZILEUKIN
Test
干预措施: PEGENZILEUKIN (Drug)
Isatuximab, Isatuximab
Test
干预措施: Isatuximab (Drug)
结局指标
主要结局
Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab
Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab
Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies
Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies
次要结局
- Part 1 (dose finding, experimental substudies): VGPR or better
- Part 2 (expansion, independent experimental substudies): VGPR or better
- Clinical Benefit Rate (CBR) in each treatment arm
- Duration of Response (DOR) in each treatment arm
- Time to First Response (TT1R) in each treatment arm
- Time to Best Response (TTBR) in each treatment arm
- Part 1 (dose finding, experimental substudies): ORR
- Number of participants with treatment emergent adverse events and serious adverse events in each treatment arm
- Progression-free survival (PFS) in each treatment arm
- Overall Survival (OS) in each treatment arm
- Immunogenicity of isatuximab and novel agents
- Concentration of novel agents (experimental arms) and isatuximab (Ctrough)
- Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
- Disease and treatment-related quality of life will be assessed using the EORTC multiple myeloma module (QLQ-MY20) questionnaire
- Global impact of side effects will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) (GP5)
- Estimate/Confirm established clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores using the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (12)
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