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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: Active Phase 3 study of Plasma Cell Myeloma Recurrent, sponsored by Sanofi.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-
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 |
What the registry record for NCT05405166 still lists
NCT05405166 is an interventional study that assigns participants to a tested intervention. The registered 531 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05405166's enrollment target sits among peer trials
531 704th of 2000 higher than 1,296 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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