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

StatusEnrolling by Invitation
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Nov 30, 2026 → Nov 30, 2028
See other at-risk trials from Sanofi

Record History

  1. Primary and study completion pushed from Nov 30, 2026 to Nov 30, 2028 Trial status changed: Active, Not Recruiting → Enrolling by Invitationv25 Show 1 more changeShow less
    • Trial status changed: Active, Not Recruiting → Enrolling by Invitation
  2. Re-verified, no change to tracked fieldsv24
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 35 to 37v23 Show 1 more changeShow less
    • Study sites: 35 to 37
  4. Study sites: 34 to 35v22
  5. Study sites: 31 to 34v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 25 to 31v20
  2. Study sites: 24 to 25v19
  3. Study sites: 23 to 24v18
  4. Primary and study completion dates: Sep 21, 2026 to Nov 30, 2026 Interventions: Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab IV (SAR650984) (Drug), Isatuximab SC (SAR650984) (Drug), Lenalidomide… to Carfilzomib (Drug), Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab intravenous (IV) (Drug), Isatuximab subcutaneous (SC)… · Eligibility criteria revisedv17 Show 2 more changesShow less
    • Interventions: Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab IV (SAR650984) (Drug), Isatuximab SC (SAR650984) (Drug), Lenalidomide… to Carfilzomib (Drug), Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab intravenous (IV) (Drug), Isatuximab subcutaneous (SC)…
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 19 to 23v16
  6. Site details revised at 2 of 19 sitesv15
  7. Study sites revised (19)v14 See this version in full on ClinicalTrials.gov ↗
  8. Re-verified, no change to tracked fieldsv13
  9. Primary and study completion dates: Sep 2026 to Sep 21, 2026 Interventions: Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab (SAR650984) (Drug), Lenalidomide (Drug), Pomalidomide (Drug) to Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab IV (SAR650984) (Drug), Isatuximab SC (SAR650984) (Drug), Lenalidomide…v12 Show 1 more changeShow less
    • Interventions: Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab (SAR650984) (Drug), Lenalidomide (Drug), Pomalidomide (Drug) to Cemiplimab (SAR439684) (Drug), Dexamethasone (Drug), Isatuximab IV (SAR650984) (Drug), Isatuximab SC (SAR650984) (Drug), Lenalidomide…
  10. Study sites: 18 to 19v11
  11. Study sites: 12 to 18v10
  12. Site details revised at 2 of 12 sitesv9
  13. Study sites: 7 to 12v8
  14. Study sites: 4 to 7v7
  15. Phase: Phase 4 to Phase 2v6
  16. Study sites: 2 to 4v5
  17. Study sites: 1 to 2 Start date changed from estimate of Mar 17, 2023 to Apr 5, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of Mar 17, 2023 to Apr 5, 2023
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  19. Start date: Jan 2023 to Mar 17, 2023 Primary and study completion dates: Jul 2026 to Sep 2026v2 Show 1 more changeShow less
    • Primary and study completion dates: Jul 2026 to Sep 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
Multiple Myeloma
1,231 trials monitored
See 77 trials at risk
* 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.
Trial Details
NCT Number NCT05669989
Lead Sponsor Sanofi
Conditions Plasma Cell Myeloma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov