SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Running, not enrolling · Phase 3

Conditions studied: Plasma Cell Myeloma Recurrent

In brief

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Key facts

Study ID

NCT05405166

Run by

Sanofi

People needed

531

Starts

2022-06-23

Expected to finish

2027-03-23

Last updated by the study team

2025-11-14

Who can join

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

You may qualify if…

• Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
• Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).

You may not qualify if…

• Primary refractory multiple myeloma participants
• Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
• Prior therapy with pomalidomide
• Participants with inadequate biological tests.
• Significant cardiac dysfunction
• Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
• Concomitant plasma cell leukemia
• Active primary amyloid light -chain amyloidosis
• Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
• Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
• Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Arizona Oncology Associates, PC - HAL- Site Number : 8400015 — Prescott Valley, Arizona, United States
• Rocky Mountain Cancer Centers, LLP- Site Number : 8400021 — Aurora, Colorado, United States
• Mayo Clinic- Site Number : 8400008 — Jacksonville, Florida, United States
• BRCR Medical Center Inc Site Number : 8400030 — Plantation, Florida, United States
• Centre for Cancer and Blood Disorders- Site Number : 8400026 — Bethesda, Maryland, United States
• Hattiesburg Clinic Site Number : 8400006 — Hattiesburg, Mississippi, United States
• Comprehensive Cancer Centers of Nevada- Site Number : 8400019 — Las Vegas, Nevada, United States
• Atlantic Health System Site Number : 8400005 — Morristown, New Jersey, United States
• New York Oncology Hematology, P.C.- Site Number : 8400017 — Albany, New York, United States
• Novant Health- Site Number : 8400014 — Charlotte, North Carolina, United States
• Novant Health Forsyth Medical Center Site Number : 8400114 — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center Site Number : 8400027 — Canton, Ohio, United States
• Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016 — Cincinnati, Ohio, United States
• Oncology Associates Of Oregon, P.C.- Site Number : 8400018 — Eugene, Oregon, United States
• Spoknwrd Clinical Trials Inc. Site Number : 8400023 — Easton, Pennsylvania, United States
• Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400002 — Spartanburg, South Carolina, United States
• Texas Oncology Baylor Sammons- Site Number : 8400022 — Dallas, Texas, United States
• University of Texas Southwestern- Site Number : 8400024 — Dallas, Texas, United States
• Lumi Research- Site Number : 8400029 — Kingwood, Texas, United States
• Texas Oncology - San Antonio- Site Number : 8400020 — San Antonio, Texas, United States
• George E. Wahlen Salt Lake City VA Medical Center- Site Number : 8400011 — Salt Lake City, Utah, United States
• UW Cancer Center at ProHealth Care Site Number : 8400001 — Waukesha, Wisconsin, United States
• Investigational Site Number : 0320007 — CABA, Buenos Aires, Argentina
• Investigational Site Number : 0320001 — CABA, Buenos Aires, Argentina
• Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028 — Bullhead City, Arizona, United States

Full record on ClinicalTrials.gov

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