SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Public ClinicalTrials.gov record NCT05405166. 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 Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05405166
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 531 participants
Conditions and interventions
Conditions
Interventions
- Dexamethasone Drug
- Diphenhydramine Drug
- Isatuximab IV Drug
- Isatuximab SC Drug
- Methylprednisolone Drug
- Montelukast Drug
- Paracetamol / Acetaminophen Drug
- Pomalidomide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 22, 2022
- Primary completion
- Nov 5, 2024
- Completion
- Mar 22, 2027
- Last update posted
- Nov 13, 2025
2022 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028 | Bullhead City | Arizona | 86442 | — |
| Arizona Oncology Associates, PC - HAL- Site Number : 8400015 | Prescott Valley | Arizona | 86314 | — |
| Rocky Mountain Cancer Centers, LLP- Site Number : 8400021 | Aurora | Colorado | 80012 | — |
| Mayo Clinic- Site Number : 8400008 | Jacksonville | Florida | 32224 | — |
| BRCR Medical Center Inc Site Number : 8400030 | Plantation | Florida | 33322 | — |
| Centre for Cancer and Blood Disorders- Site Number : 8400026 | Bethesda | Maryland | 20817 | — |
| Hattiesburg Clinic Site Number : 8400006 | Hattiesburg | Mississippi | 39401 | — |
| Comprehensive Cancer Centers of Nevada- Site Number : 8400019 | Las Vegas | Nevada | 89169 | — |
| Atlantic Health System Site Number : 8400005 | Morristown | New Jersey | 07960 | — |
| New York Oncology Hematology, P.C.- Site Number : 8400017 | Albany | New York | 12206 | — |
| Novant Health- Site Number : 8400014 | Charlotte | North Carolina | 28207 | — |
| Novant Health Forsyth Medical Center Site Number : 8400114 | Winston-Salem | North Carolina | 27103 | — |
| Gabrail Cancer Center Site Number : 8400027 | Canton | Ohio | 44718 | — |
| Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016 | Cincinnati | Ohio | 45236 | — |
| Oncology Associates Of Oregon, P.C.- Site Number : 8400018 | Eugene | Oregon | 97401 | — |
| Spoknwrd Clinical Trials Inc. Site Number : 8400023 | Easton | Pennsylvania | 18045 | — |
| Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400002 | Spartanburg | South Carolina | 29303 | — |
| Texas Oncology Baylor Sammons- Site Number : 8400022 | Dallas | Texas | 75246 | — |
| University of Texas Southwestern- Site Number : 8400024 | Dallas | Texas | 75390 | — |
| Lumi Research- Site Number : 8400029 | Kingwood | Texas | 77339 | — |
| Texas Oncology - San Antonio- Site Number : 8400020 | San Antonio | Texas | 78240 | — |
| George E. Wahlen Salt Lake City VA Medical Center- Site Number : 8400011 | Salt Lake City | Utah | 84148 | — |
| UW Cancer Center at ProHealth Care Site Number : 8400001 | Waukesha | Wisconsin | 53188 | — |
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 123 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05405166, 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 Nov 13, 2025 · Synced Jul 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05405166 live on ClinicalTrials.gov.