Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?

Trial Details

NCT ID
NCT06182774
Phase
PHASE3
Sponsor
Canadian Cancer Trials Group
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Daratumumab
  • Lenalidomide
  • Dexamethasone
  • Isatuximab
Locations (sample)
  • Kelowna, British Columbia, Canada|49.88307,-119.48568
  • Vancouver, British Columbia, Canada|49.24966,-123.11934
  • Winnipeg, Manitoba, Canada|49.8844,-97.14704
  • Moncton, New Brunswick, Canada|46.09454,-64.7965
  • Saint John, New Brunswick, Canada|45.27076,-66.05616

Key Eligibility Criteria

  • Participants with newly diagnosed multiple myeloma that are transplant-ineligible
  • Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum monoclonal protein (M-protein) ≥ 5 g/L; Ur…
  • Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.
  • Obtained at least a partial response per the standard 2016 IMWG criteria

For full eligibility, visit ClinicalTrials.gov.

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