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Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma

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

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Site contact updatedv9
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2025 to Oct 9, 2025 · Site details revisedv8 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2025 to Oct 9, 2025
    • Site details revised
  4. Start date: May 2025 to Jul 2025v7
  5. Start date: Mar 2025 to May 2025v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Jan 2025 to Mar 2025v5
  2. Start date: Nov 2024 to Jan 2025v4
  3. Start date: Sep 2024 to Nov 2024 Primary completion date: Sep 2026 to Nov 2026 · Completion date: Sep 2027 to Nov 2027v3 Show 2 more changesShow less
    • Primary completion date: Sep 2026 to Nov 2026
    • Completion date: Sep 2027 to Nov 2027
  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
University of Utah
302 trials monitored
See 17 trials at risk
Leukemia
2,566 trials monitored
See 143 trials at risk
Multiple Myeloma
1,231 trials monitored
See 77 trials at risk
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.
Trial Details
NCT Number NCT06517017
Lead Sponsor University of Utah
Collaborators: Sanofi
Conditions Multiple Myeloma, Plasma Cell Leukemia
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov