Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

This research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to avoid or possibly reduce any unwanted side effects commonly associated with these drugs. Using lower doses of the combination isatuximab, lenalidomide and dexamethasone, has not been approved by the Food and Drug Administration (FDA) for the treatment of newly diagnosed MM.

Trial Details

NCT ID
NCT05145400
Phase
PHASE2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Isatuximab
  • Lenalidomide
  • Dexamethasone
Locations (sample)
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584
  • Charlotte, North Carolina, United States|35.22709,-80.84313
  • Durham, North Carolina, United States|35.99403,-78.89862
  • Wilmington, North Carolina, United States|34.23556,-77.94604
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for rel…
  • Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator or protocol desig…
  • Predicted high risk for severe toxicity from intensive induction regimens, such as standard (full-dose) Bortezomib, cyclophosphamide, dexamethasone…
  • Score ≥ 2 (indicating "frail") on the International Myeloma Working Group instrument (IMWG; Palumbo et al. \[Blood 2015\]),

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

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