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ACTIVE NOT RECRUITING Phase 2

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

NCT05669989 · View on ClinicalTrials.gov ↗

Study Summary

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Pomalidomide
  • DRUG Isatuximab intravenous (IV)
  • DRUG Cemiplimab (SAR439684)

Study Locations (20)

Other

  • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001 — Rio de Janeiro
  • Investigational Site Number : 1520001 — Temuco
  • Investigational Site Number : 1560001 — Tianjin
  • Investigational Site Number : 2030002 — Brno
  • Investigational Site Number : 2030003 — Ostrava
  • Investigational Site Number : 2030001 — Prague
  • Investigational Site Number : 2460001 — Helsinki
  • Investigational Site Number : 2500002 — Nantes
  • Investigational Site Number : 3000004 — Athens
  • Investigational Site Number : 3000003 — Athens
  • Investigational Site Number : 3000001 — Pátrai

New South Wales

  • Investigational Site Number : 0360006 — Blacktown
  • Investigational Site Number : 0360001 — Saint Leonards
  • Investigational Site Number : 0360003 — Wollongong

Victoria

  • Investigational Site Number : 0360004 — Melbourne
  • Investigational Site Number : 0360005 — Melbourne
  • Investigational Site Number : 0360002 — Richmond

Missouri

  • Washington University- Site Number : 8400001 — St Louis

Rio Grande do Sul

  • Hospital Mae de Deus- Site Number : 0760003 — Porto Alegre

São Paulo

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002 — São Paulo

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-04-05
Est. Completion 2026-11-30
Phase Phase 2

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05669989

The ClinicalTrials.gov registry entry for NCT05669989 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 70 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 appearing as the primary indexed condition, and to 5 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: NCT05669989 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, New South Wales, Victoria. 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 NCT05669989 about?

NCT05669989 is a clinical study titled "International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab". * This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued acces...

What is the current status of trial NCT05669989?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-04-05. Estimated completion is 2026-11-30.

What conditions does trial NCT05669989 study?

This clinical trial studies the following conditions: Plasma Cell Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05669989?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Pomalidomide (DRUG), Isatuximab intravenous (IV) (DRUG), Cemiplimab (SAR439684) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05669989?

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 NCT05669989 being conducted?

This trial has 20 study locations across Missouri, New South Wales, Victoria, Rio Grande do Sul, São Paulo. 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