Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinat

Trial Details

NCT ID
NCT05561387
Phase
PHASE3
Sponsor
SWOG Cancer Research Network
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Bortezomib
  • Daratumumab and Hyaluronidase-fihj
  • Dexamethasone
  • Lenalidomide
  • Quality-of-Life Assessment
  • Questionnaire Administration
Locations (sample)
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Fort Smith, Arkansas, United States|35.38592,-94.39855
  • Little Rock, Arkansas, United States|34.74648,-92.28959

Key Eligibility Criteria

  • Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 day…
  • Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
  • Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>= 0.5 gram/deciliter \[g/dL\] or urine M-protein level \>= 200 mi…
  • IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR

For full eligibility, visit ClinicalTrials.gov.

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