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Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 93 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 22 to 23
  2. Study sites: 21 to 22
  3. Study sites: 19 to 21
  4. Trial sites expanded: 14 → 17 locations
  5. Trial sites expanded: 1 → 14 locations
  6. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 26, 2026 to May 22, 2027 · Study sites: 0 to 14 Show 2 more changesShow less
    • Start date: Aug 26, 2026 to May 22, 2027
    • Study sites: 0 to 14
  7. Changed Recruitment opened
  8. Re-verified, no change to tracked fieldsv87
  9. Start date: Apr 29, 2026 to Aug 26, 2026v86
  10. 39 versions Re-verified since Feb 14, 2026, no change to tracked fieldsv47-v85
  11. Primary and study completion dates: Feb 28, 2026 to Feb 28, 2028 Start date: Jan 29, 2026 to Apr 29, 2026v46 Show 1 more changeShow less
    • Start date: Jan 29, 2026 to Apr 29, 2026
  12. 2 versions Re-verified since Feb 10, 2026, no change to tracked fieldsv44-v45
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.
Trial Details
NCT Number NCT06948084
Lead Sponsor National Cancer Institute (NCI)
Conditions Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov