2024-514992-16-00招募中2 期
Phase 1/2 trial evaluating isatuximab in combination with SAR445761 (belumosudil) and dexamethasone in relapsed or refractory multiple myeloma (RRMM)
Sanofi-Aventis Recherche & Developpement13 个研究点 分布在 6 个国家目标入组 17 人开始时间: 2024年4月24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
- 17
- 试验地点
- 13
- 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（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
- •Substudy 05: Participants with RRMM with at least 1 cycle of prior exposure to anti- CD38 therapy. For participants to whom BCMA targeted therapy is available (ie, approved in their region and can be reimbursed), at least 2 cycles of prior exposure to a BCMA targeted agent is mandatory
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 05:Unable to swallow tablets.
- •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
SAR445761 - belumosudil
Test
干预措施: SAR445761 - belumosudil (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
- Time to Best Response (TTBR) in each treatment arm
- Part 1 (dose finding, experimental substudies): ORR
- 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
- 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
- Maximum concentration observed after the first infusion (Cmax) for Belumosudil - Substudy 05
- Time to reach Cmax (tmax) for Belumosudil - Substudy 05
- Area under the concentration versus time curve calculated using the trapezoidal method from 0 to 8h (AUC0-8h) for Belumosudil - Substudy 05
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (13)
Loading locations...
相似试验
招募中
2 期
A Phase 2 Study of Isatuximab in combination with Pomalidomide and Dexamethasone in MM Patients who received one prior line of therapy containing Lenalidomide and a Proteasome Inhibitor2024-516060-28-00Hellenic Society Of Hematology108
招募中
2 期
A Phase 2 Study of Isatuximab in combination with Bortezomib, Cyclophosphamide and Dexamethasone followed by isatuximab and lenalidomide maintenance in Newly Diagnosed Patients with Multiple Myeloma and severe Renal Impairment2024-516061-36-00Hellenic Society Of Hematology51
招募中
3 期
A study to investigate the clinical benefit of isatuximab in combination with bortezomib, lenalidomide and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplantCancer2024-514417-34-00Sanofi-Aventis Recherche & Developpement308
招募中
2 期
Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)2024-515581-13-00Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH138
尚未招募
2 期
A study to compare two drugs (Rituximab and Tacrolimus) for treatment of difficult to treat kidney disease in childrenCTRI/2025/10/096742Dr Anannya Biswas60