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

Part of paid clinical trials in Buffalo, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07605416
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Plasma Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo autoHSCT
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Carfilzomib — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and/or CT
  • Daratumumab and Recombinant Human Hyaluronidase — DRUG
    Given SC
  • Dexamethasone — DRUG
    Given PO
  • Fludeoxyglucose F-18 — OTHER
    Undergo FDG PET/CT
  • Lenalidomide — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Melphalan — DRUG
    Given IV
  • Plerixafor — DRUG
    Given SC
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Recombinant Granulocyte Colony-Stimulating Factor — BIOLOGICAL
    Given SC
  • Stem Cell Isolation — PROCEDURE
    Undergo stem cell collection
  • Teclistamab — DRUG
    Given SC
  • Transthoracic Echocardiography Test — PROCEDURE
    Undergo TTE

Study Details

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.

Key Dates

First listed
May 26, 2026
Start date
Apr 20, 2027
Status verified
Aug 2026
Primary completion
Nov 6, 2032
Completion
Nov 6, 2032

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1 (induction, autoHSCT, D-KRd, maintenance)
    See Detailed Description.
  • Experimental: Arm 2 (induction, autoHSCT, teclistamab, maintenance)
    See Detailed Description.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From randomization to the time of death due to any cause, assessed up to 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Site Public Contact
[email protected]
800-767-9355
Hamza Hassan (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Site Public Contact
[email protected]
888-424-2100
Douglas W. Sborov (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NYHuntsman Cancer Institute/University of Utah· Salt Lake City, UT

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