EUCTR2020-003024-16-GR进行中（未招募）1 期
Phase 1-2 UMBRELLA trial evaluating isatuximab with or without dexamethasone in combination with novel agents in relapsed or refractory multiple myeloma (RRMM) - Master protocol
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 147 人开始时间: 2020年12月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participant must be 18 years of age inclusive or older
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •- Participants with relapsed or refractory MM who have received at least
- •3 prior lines of therapy for MM, including PIs and IMiDs or at least 2
- •prior lines if at least one of these lines consisted of 2 or more multiagent
- •regimens (eg, Induction regimen with autologous stem cell transplant
- •followed by maintenance)
- •- RRMM with measurable disease:
- •->Serum M protein =0.5 g/dL measured using serum protein
- •immunoelectrophoresis and/or
- •->Urine M protein =200 mg/24 hours measured using urine protein
- •immunoelectrophoresis and/or
- •->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 01, 02(Terminated), 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
- •-Substudy 04: Anti-CD38 and anti-BCMA therapy prior exposed participants with RRMM.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •Medical conditions:
- •- Primary systemic amyloid light chain amyloidosis, plasma cell
- •leukemia, monoclonal gammopathy of undetermined significance, or
- •smoldering myeloma
- •- Uncontrolled infection within 14 days prior to first study intervention administration.
- •- 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 randomization
- •Prior concomitant therapy:
- •- Any anti-MM drug treatment within 14 days before randomization,
- •including dexamethasone
- •- Participants with a contraindication to treatment
- •- Vaccination with a live vaccine 4 weeks before the start of the study
- •Criteria diagnostic assessment:
- •- Hemoglobin <8 g/dL
- •- Platelets <50 × 109/L
- •- Absolute neutrophil count <1.5 × 109/L
- •- Creatinine clearance <30 mL/min
- •- 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
- •Substudy 01:
- •-> Malabsorption syndrome or any condition that can significantly
- •impact the absorption of pomalidomide
- •-Substudy02(terminated):History of resected/ablated basal or squamous cell carcinoma(SCC)of the skin or carcinoma in situ of the cervix, or other local tumors, even if considered cured by local treatment.Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior to the first dose of SAR439459. Prothrombin time or INR >1.5 × upper limit of normal (ULN).
- •- Substudy 03:
- •Current corneal epithelial disease except mild punctate keratopathy
- •Patients who have received prior therapy with belantamab mafodotin
- •-Substudy04:Central nervous system or leptomeningeal disease.
- •Medical history of seizure.Participants currently receiving hepatically metabolized narrow therapeutic index drugs (eg,digoxin, warfarin) if cannot be closely monitored.
研究者
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