2024-514989-40-00招募中2 期
Phase 1/2 trial evaluating isatuximab in combination with belantamab mafodotin and dexamethasone in relapsed or refractory multiple myeloma (RRMM)
Sanofi-Aventis Recherche & Developpement3 个研究点 分布在 3 个国家目标入组 3 人开始时间: 2021年11月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 3
- 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, controlled experimental substudies): -To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of rate of very good partial response (VGPR) or better.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ 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.
- •Substudies 03: Anti-CD38 therapy naïve or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose. “Refractory” is defined as progressing within 60 days of last dose of anti-CD38 targeting 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 03:Current corneal epithelial disease except mild punctate keratopathy
- •Substudy 03:Patients who have received prior therapy with belantamab mafodotin.
- •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
Dexamethason 8 mg JENAPHARM®, Dexamethason 4 mg JENAPHARM®
Test
干预措施: Dexamethason 8 mg JENAPHARM® (Drug)
Dexamethason 8 mg JENAPHARM®, Dexamethason 4 mg JENAPHARM®
Test
干预措施: Dexamethason 4 mg JENAPHARM® (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, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)
Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)
次要结局
- 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
- Part 2 (expansion, controlled experimental substudies): ORR
- Part 1 (dose finding, experimental substudies): VGPR or better
- Clinical Benefit Rate (CBR) in each treatment arm
- Duration of Response (DOR) in each treatment arm
- 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
- To assess patient-reported visual functioning for experimental arm only (Substudy 03)
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (3)
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