EUCTR2020-003024-16-DE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 229 人开始时间: 2021年5月25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
- 229
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 0-1
- •- 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
- •->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, 06: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 6 months after the last dose.
- •Exposure is defined as at least 2 cycles of therapy.
- •- Substudy 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-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.
- •-Substudy 05: Participants with RRMM with at least 2 cycles 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.
- •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 first study intervention administration.
- •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
- •- Seasonal flu and COVID-19 vaccines that do not contain live virus are
- •Criteria diagnostic assessment:
- •- Hemoglobin <8 g/dL
- •- Platelets <50 × 109/L
- •- Absolute neutrophil count <1.5 × 109/L
- •- Creatinine clearance <30 mL/min / 1.73m2
- •- 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
- •-> For the first 10 participants: Body weight =70 kg
- •- Substudy 03 (Terminated):
- •Current corneal epithelial disease except mild punctate keratopathy
- •Patients who have received prior therapy with belantamab mafodotin
- •- Substudy 04:
- •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.
- •-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.
- •-Prior allogeneic hematopoietic stem cell transplant (allo-HSCT)
- •Substudy 05:
- •- Participant unable to swallow tablets
- •Substudy 06:
- •- History of active autoimmune disorders
- •- History of autoimmune hemolyt
研究者
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