Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Active, not recruiting · Phase 3 · NCT04270409
Conditions: Plasma Cell Myeloma
At a glance
- Research payments reported, 2025
- $421,316
- U.S. investigators named
- 9
- Sites paid
- 7
- Planned or actual enrollment
- 337
About the trial
- Sponsor
- Sanofi
- Tested
- Isatuximab SAR650984 (drug), Lenalidomide (drug), Dexamethasone (drug), Montelukast or equivalent (drug), Acetaminophen (drug), Diphenhydramine or equivalent (drug), Methylprednisolone or equivalent (drug)
- Dates
- Started 2020-06-16; completion 2033-10-21
- Results posted
- Not yet
Primary Objectives: * Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in Part: * To assess overall response rate (ORR) * To assess duration of response (DOR) * To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or …
From ClinicalTrials.gov, last updated 2025-12-12. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $421,316 in research payments for this study in 2025 (82 payments).
Products named: Sarclisa
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Sarah M. Larson, M.D. Hematology & Oncology · Los Angeles, CA
- Henning H. Schade, M.D. Hematology & Oncology · Denver, CO
- Dickran G. Kazandjian, M.D. Hematology & Oncology · Miami, FL
- Mehdi M. Moezi, MD Hematology & Oncology · Fleming Island, FL
- Irene M. Ghobrial, M.D. Medical Oncology · Boston, MA
- Franklin L. Chen, M.D. Hematology · Winston Salem, NC
- Jesus G. Berdeja, M.D. Hematology & Oncology · Nashville, TN
- Elisabet Manasanch, M.D. Medical Oncology · Houston, TX
- Krina K. Patel, M.D. Internal Medicine · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ut MD Anderson Cancer Center $107,743
- Ronald Reagan UCLA Medical Center, CA $91,076
- Office of Research Administration $54,341
- Sarah Cannon Research Inst LLC $49,671
- Dana Farber Mass General Brigham Ca Care Inc $45,633
- Forsyth Memorial Hospital Inc $36,651
- Cancer Specialists Llc $36,202
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.