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NCT05405166 · ClinicalTrials.gov registry record · Phase 3
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
A Phase 3 study of Plasma Cell Myeloma Recurrent, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 531
- Enrollment target
- 20
- Study locations
NCT05405166 is a Phase 3 study of Plasma Cell Myeloma Recurrent that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 531 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT05405166, a Phase 3 study of Plasma Cell Myeloma Recurrent, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 531 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Isatuximab SC
- DRUG Isatuximab IV
Study Locations (20)
Texas
- Texas Oncology Baylor Sammons- Site Number : 8400022 - Dallas
- University of Texas Southwestern- Site Number : 8400024 - Dallas
- Lumi Research- Site Number : 8400029 - Kingwood
Arizona
- Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028 - Bullhead City
- Arizona Oncology Associates, PC - HAL- Site Number : 8400015 - Prescott Valley
Florida
- Mayo Clinic- Site Number : 8400008 - Jacksonville
- BRCR Medical Center Inc Site Number : 8400030 - Plantation
North Carolina
- Novant Health- Site Number : 8400014 - Charlotte
- Novant Health Forsyth Medical Center Site Number : 8400114 - Winston-Salem
Ohio
- Gabrail Cancer Center Site Number : 8400027 - Canton
- Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016 - Cincinnati
Colorado
- Rocky Mountain Cancer Centers, LLP- Site Number : 8400021 - Aurora
Maryland
- Centre for Cancer and Blood Disorders- Site Number : 8400026 - Bethesda
Mississippi
- Hattiesburg Clinic Site Number : 8400006 - Hattiesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2027-03-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05405166
The ClinicalTrials.gov registry entry for NCT05405166 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 531 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Plasma Cell Myeloma Recurrent appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT05405166 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05405166 about?
NCT05405166 is a clinical study titled "SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM". 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 lenali...
What is the current status of trial NCT05405166?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2022-06-23. Estimated completion is 2027-03-23.
What conditions does trial NCT05405166 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma Recurrent.
What interventions are being tested in trial NCT05405166?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab SC (DRUG), Isatuximab IV (DRUG).
Who is sponsoring clinical trial NCT05405166?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05405166 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Maryland, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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