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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 397 sitesv10
  2. Primary completion date: Mar 31, 2030 to May 30, 2031 Completion date: Apr 15, 2030 to May 30, 2031v9 Show 1 more changeShow less
    • Completion date: Apr 15, 2030 to May 30, 2031
  3. Study sites: 279 to 397v8
  4. Start date: Jun 1, 2023 to Oct 12, 2023 Study sites: 193 to 279v7 Show 1 more changeShow less
    • Study sites: 193 to 279
  5. Study sites: 1 to 193v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Not Yet Recruiting to Recruiting Start date: May 1, 2023 to Jun 1, 2023 · Study sites: 0 to 1v4 Show 2 more changesShow less
    • Start date: May 1, 2023 to Jun 1, 2023
    • Study sites: 0 to 1
  3. Start date: Feb 1, 2023 to May 1, 2023v3
  4. Start date: Dec 1, 2022 to Feb 1, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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 combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Trial Details
NCT Number NCT05561387
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Conditions Plasma Cell Myeloma
Enrollment 510 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov