Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Public ClinicalTrials.gov record NCT04270409. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT04270409
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 337 participants
Conditions and interventions
Conditions
Interventions
- Acetaminophen Drug
- Dexamethasone Drug
- Diphenhydramine or equivalent Drug
- Isatuximab SAR650984 Drug
- Lenalidomide Drug
- Methylprednisolone or equivalent Drug
- Montelukast or equivalent Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 15, 2020
- Primary completion
- Oct 13, 2030
- Completion
- Oct 20, 2033
- Last update posted
- Dec 11, 2025
2020 – 2033
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Site Number : 8400010 | Los Angeles | California | 90024 | — |
| Colorado Blood Cancer Institute Site Number : 8400007 | Denver | Colorado | 80218 | — |
| Cancer Specialist of North Florida Site Number : 8400011 | Jacksonville | Florida | 32256 | — |
| University of Miami Site Number : 8400012 | Miami | Florida | 33136 | — |
| Dana Farber Cancer Institute Site Number : 8400001 | Boston | Massachusetts | 02115 | — |
| Presbyterian Hospital Site Number : 8400015 | Charlotte | North Carolina | 28204 | — |
| Novant Health Forsyth Medical Center Site Number : 8401015 | Winston-Salem | North Carolina | 27103 | — |
| Tennessee Oncology Site Number : 8400006 | Nashville | Tennessee | 37203 | — |
| ~University of Texas - MD Anderson Cancer Center Site Number : 8400002 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04270409, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2025 · Synced May 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04270409 live on ClinicalTrials.gov.