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

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 treatm

Trial Details

NCT ID
NCT06517017
Phase
PHASE2
Sponsor
University of Utah
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Isatuximab
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • Male or female subject aged ≥ 18 years.
  • Histologically confirmed myeloma and/or Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.
  • For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical ster…
  • Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and ha…

For full eligibility, visit ClinicalTrials.gov.

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