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ACTIVE NOT RECRUITING Phase 3

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

NCT05405166 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 531 participants
Start Date 2022-06-23
Est. Completion 2027-03-23
Phase Phase 3

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05405166 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05405166?

The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab SC (DRUG), Isatuximab IV (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05405166?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial