Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma (NCT04270409)
A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma
🩺 Plain-English Summary (8th-Grade Level)
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 complete response (CR) * To assess time to diagnostic (SLiM CRAB) progression or death * To assess time to first-line treatment for multiple myeloma (MM) * To assess the potential immunogenicity of isatuximab * Impact of abnormal chromosomal subtype on participant outcome Randomized Phase 3 Part: Key Secondary Objectives: To compare between the arms * MRD negativity * Sustained MRD negativity * Second progression-free survival (PFS2) * Overall survival Other Secondary Objectives: To evaluate in both arms * CR rate * ORR * DOR * Time to diagnostic (SLiM CRAB) progression * Time to biochemical progression * Time to first-line treatment for MM * Impact of abnormal chromosomal subtype on participant outcome * Safety and tolerability * Pharmacokinetics (PK) * Potential of isatuximab immunogenicity * Clinical outcome assessments (COAs)
Who can join: Review the eligibility criteria below.
Location: UCLA Site Number : 8400010 — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (105 Sites)
Showing the first 25 of 105 sites.
- UCLA Site Number : 8400010 — Los Angeles, California
- Colorado Blood Cancer Institute Site Number : 8400007 — Denver, Colorado
- Cancer Specialist of North Florida Site Number : 8400011 — Jacksonville, Florida
- University of Miami Site Number : 8400012 — Miami, Florida
- Dana Farber Cancer Institute Site Number : 8400001 — Boston, Massachusetts
- Presbyterian Hospital Site Number : 8400015 — Charlotte, North Carolina
- Novant Health Forsyth Medical Center Site Number : 8401015 — Winston-Salem, North Carolina
- Tennessee Oncology Site Number : 8400006 — Nashville, Tennessee
- ~University of Texas - MD Anderson Cancer Center Site Number : 8400002 — Houston, Texas
- Investigational Site Number :0360008 — Liverpool, New South Wales
- Investigational Site Number :0360005 — Waratah, New South Wales
- Investigational Site Number :0360001 — Wollongong, New South Wales
- Investigational Site Number :0360002 — Fitzroy, Victoria
- Investigational Site Number :0360007 — Heidelberg West, Victoria
- Investigational Site Number :0360004 — Richmond, Victoria
- Investigational Site Number :0360006 — Nedlands, Western Australia
- Investigational Site Number :0760002 — São Paulo, São Paulo
- Investigational Site Number :1240004 — Edmonton, Alberta
- Investigational Site Number :1240005 — Moncton, New Brunswick
- Investigational Site Number :1240001 — Montreal, Quebec
- Investigational Site Number :1560002 — Hangzhou,
- Investigational Site Number :1560003 — Hangzhou,
- Investigational Site Number :1560006 — Nanchang,
- Investigational Site Number :1560004 — Shanghai,
- Investigational Site Number :1560005 — Shenyang,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma — Anchorage, Alaska
- Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma — Atlanta, Georgia
- Lenalidomide Maintenance in Plasma Cell Myeloma — Basking Ridge, New Jersey
- Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma — Duarte, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.