Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07463807
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo urine and blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and/or aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and/or aspiration
  • Carfilzomib — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo FDG PET/CT
  • Dexamethasone — DRUG
    Given PO or IV
  • FDG-Positron Emission Tomography — PROCEDURE
    Undergo FDG PET/CT
  • Fludeoxyglucose F-18 — OTHER
    Given FDG
  • Pomalidomide — DRUG
    Given PO
  • Teclistamab — DRUG
    Given SC

Study Details

This phase Ib/II trial compares the effect of teclistamab and pomalidomide to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), 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. Carfilzomib blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. It is a type of proteasome inhibitor. 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. Giving teclistamab and pomalidomide may be safe, tolerable and improve response by lowering myeloma cells to undetectable levels when compared to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with relapsed multiple myeloma.

Key Dates

Start date
Jun 26, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

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

Arms

  • Active Comparator: Arm D (carfilzomib, pomalidomide, dexamethasone)
    Patients receive carfilzomib IV on days 1, 2, 8, and 15 of cycle 1, on days 1, 8, and 15 of cycle 2, then on days 1 and 15 of subsequent cycles, pomalidomide PO QD on days 1-21 and dexamethasone PO or IV on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo urine and blood sample collection, FDG PET/CT, and bone marrow biopsy and/or aspiration throughout the study.
  • Experimental: Arms A and B (teclistamab, pomalidomide)
    Patients teclistamab SC on days 1, 4, 7, 14, and 21 of cycle 1, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, then on day 1 of remaining cycles. Starting with cycle 2, patients receive pomalidomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo urine and blood sample collection, FDG PET/CT, and bone marrow biopsy and/or aspiration throughout the study.
  • Experimental: Arms C (teclistamab, pomalidomide)
    Patients teclistamab SC on days 1, 4, 7, 14, and 21 of cycle 1, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, then on day 1 of subsequent cycles. Starting with cycle 2, patients receive pomalidomide PO QD on days 1-21 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo urine and blood sample collection, FDG PET/CT, and bone marrow biopsy and/or aspiration throughout the study.

Primary Outcome Measure

Incidence of dose limiting toxicities (Phase Ib) [ Time Frame: During cycle 2 (cycle length = 28 days) ]

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