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Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

Study acronym: MODIFY
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2029 to Nov 2032
    • Study sites: 0 to 2
    • Study completion date: Sep 30, 2030 to Nov 2032
    • Start date changed from estimate of Mar 31, 2025 to Jun 2, 2025
  2. Minor Interventions: Dexamethasone (Drug), Ibderomide (Drug), Isatuximab (Drug) to Dexamethasone (Drug), Iberdomide (Drug), Isatuximab (Drug)v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma. The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.
Trial Details
NCT Number NCT06762769
Lead Sponsor University College, London
Collaborators: Sanofi, Bristol Myers Squibb Pharmaceuticals Limited
Conditions
(from sponsor)
Smouldering Myeloma
Related terms Smoldering Multiple Myeloma
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov