Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Recruiting now · Phase 1/Phase 2

Conditions studied: Plasma Cell Myeloma Refractory

In brief

The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

Key facts

Study ID

NCT04643002

Run by

Sanofi

People needed

258

Starts

2021-01-25

Expected to finish

2028-04-20

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 12 months after the last dose. "Exposure" is defined as at least 2 cycles of therapy.
• Substudies 02, 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.

You may not qualify if…

• 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.
• Any anti-MM drug treatment within 14 days before first study intervention administration, 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 permitted.
• Hemoglobin <8 g/dL.
• Platelets <50 × 10\^9/L.
• Absolute neutrophil count <1.0 × 10\^9/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.
• Substudy 02:
• 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).

Where it is running

• Investigational Site Number : 4100003 — Seoul, Seoul-teukbyeolsi, South Korea (enrolling)
• Winship Cancer Institute of Emory University- Site Number : 8400010 — Atlanta, Georgia, United States (enrolling)
• University of Michigan Health System - Ann Arbor- Site Number : 8400004 — Ann Arbor, Michigan, United States (enrolling)
• Roswell Park Cancer Institute- Site Number : 8400008 — Buffalo, New York, United States (enrolling)
• The Ohio State University- Site Number : 8400012 — Columbus, Ohio, United States (enrolling)
• Investigational Site Number : 0360006 — Wollongong, New South Wales, Australia (enrolling)
• Investigational Site Number : 0360002 — Melbourne, Victoria, Australia (enrolling)
• Investigational Site Number : 0360001 — Richmond, Victoria, Australia (enrolling)
• Investigational Site Number : 2500003 — Paris, Washington, France (enrolling)
• Investigational Site Number : 2500002 — Lille, France (enrolling)
• Investigational Site Number : 2500001 — Nantes, France (enrolling)
• Investigational Site Number : 2500004 — Paris, France (enrolling)
• Investigational Site Number : 2760006 — Frankfurt, Germany (enrolling)
• Investigational Site Number : 2760008 — Lübeck, Germany (enrolling)
• Investigational Site Number : 3000002 — Athens, Greece (enrolling)
• Investigational Site Number : 3000001 — Athens, Greece (enrolling)
• Investigational Site Number : 3760002 — Jerusalem, Israel (enrolling)
• Investigational Site Number : 3760003 — Ramat Gan, Israel (enrolling)
• Investigational Site Number : 3760001 — Tel Aviv, Israel (enrolling)
• Investigational Site Number : 3800001 — Meldola, Reggio Emilia, Italy (enrolling)
• Investigational Site Number : 5780001 — Oslo, Norway (enrolling)
• Puerto Rico Medical Research Center- Site Number : 8400005 — Hato Rey, Puerto Rico, Puerto Rico (enrolling)
• Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea (enrolling)
• Investigational Site Number : 4100004 — Seoul, Seoul-teukbyeolsi, South Korea (enrolling)
• Investigational Site Number : 4100002 — Seoul, Seoul-teukbyeolsi, South Korea (enrolling)

Full record on ClinicalTrials.gov

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