Status:
ACTIVE_NOT_RECRUITING
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Lead Sponsor:
Sanofi
Conditions:
Plasma Cell Myeloma Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 RR...
Detailed Description
Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Eligibility Criteria
Inclusion
- 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)).
Exclusion
- 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.
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2027
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT05405166
Start Date
June 23 2022
End Date
March 23 2027
Last Update
November 14 2025
Active Locations (146)
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1
Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028
Bullhead City, Arizona, United States, 86442
2
Arizona Oncology Associates, PC - HAL- Site Number : 8400015
Prescott Valley, Arizona, United States, 86314
3
Rocky Mountain Cancer Centers, LLP- Site Number : 8400021
Aurora, Colorado, United States, 80012
4
Mayo Clinic- Site Number : 8400008
Jacksonville, Florida, United States, 32224