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 will be 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 will receive at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants were randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants are 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
- Isatuximab IV Drug
- Isatuximab SC Drug
- Dexamethasone Drug
- Pomalidomide Drug
- Montelukast Drug
- Paracetamol / Acetaminophen Drug
- Diphenhydramine Drug
- Methylprednisolone 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 23, 2022 (Actual)
- Primary completion
- Nov 6, 2024 (Actual)
- Completion
- Oct 22, 2027 (Estimated)
- Last update posted
- Sep 2, 2026
2022 – 2027
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021 | Aurora | Colorado | 80012 | — |
| Mayo Clinic in Florida- Site Number : 8400008 | Jacksonville | Florida | 32224 | — |
| Boca Raton Clinical Research Associates- Site Number : 8400030 | Plantation | Florida | 33322 | — |
| Hattiesburg Clinic- Site Number : 8400006 | Hattiesburg | Mississippi | 39401 | — |
| Atlantic Health System- Site Number : 8400005 | Morristown | New Jersey | 07962 | — |
| New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017 | Albany | New York | 12206 | — |
| Novant Health Neurology & Sleep- Site Number : 8400014 | Charlotte | North Carolina | 28207 | — |
| Gabrail Cancer Center- Site Number : 8400027 | Canton | Ohio | 44718 | — |
| Oncology Hematology Care - Fairfield- Site Number : 8400016 | Fairfield | Ohio | 45014 | — |
| Spartanburg Regional Medical Center- Site Number : 8400002 | Spartanburg | South Carolina | 29303 | — |
| University of Texas - Southwestern Medical Center- Site Number : 8400024 | Dallas | Texas | 75390 | — |
| Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020 | San Antonio | Texas | 78240 | — |
| Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011 | Salt Lake City | Utah | 84108 | — |
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 115 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 Sep 2, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05405166 live on ClinicalTrials.gov.