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Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 8 to 10
  2. Study sites: 7 to 8
  3. Trial sites expanded: 2 → 7 locations Eligibility criteria expanded, about 47 words · Secondary endpoints: details revised at 3 of 3 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
  4. Study sites revised (2)v6 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 1 to 2v5
  6. Re-verified, no change to tracked fieldsv4
  7. Recruitment opened Start date: Jul 29, 2026 to Apr 20, 2027 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Start date: Jul 29, 2026 to Apr 20, 2027
    • Study sites: 0 to 1
  8. Start date: Jul 1, 2026 to Jul 29, 2026v2
  9. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. 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. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. 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. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.
Trial Details
NCT Number NCT07605416
Lead Sponsor National Cancer Institute (NCI)
Conditions Plasma Cell Leukemia
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov