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NCT05669989 · ClinicalTrials.gov registry record · Phase 2
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
A Phase 2 study of Plasma Cell Myeloma, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT05669989: Active Phase 2 study of Plasma Cell Myeloma, sponsored by Sanofi.
NCT05669989 is a Phase 2 study of Plasma Cell Myeloma that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 70 participants, below the 206-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05669989, a Phase 2 study of Plasma Cell Myeloma, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 2 |
What the registry record for NCT05669989 still lists
NCT05669989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 206-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (66% lower).
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.
NCT05669989 names 20 study sites across 6 states, led by Other, New South Wales, Victoria.
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.
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).
Who is sponsoring clinical trial NCT05669989?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05669989's enrollment target sits among peer trials
70 18th of 32 higher than 15 of 32 other Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plasma Cell Myeloma 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.
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