Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06627751
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extramedullary Disease in Multiple Myeloma
  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Mezigdomide — BIOLOGICAL
    Given PO
  • Carfilzomib — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given PO
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Computed Tomography Assisted Biopsy — PROCEDURE
    Undergo CT guided tumor Biopsy
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood and saliva sample collection

Study Details

This phase II trial studies how well mezigdomide/carfilzomib/dexamethasone (MeziKD) works in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and have tumors from myeloma cells outside the bone marrow in the soft tissues or organs of the body (extramedullary disease \[EMD\]). Mezigdomide blocks important processes in myeloma cells and may lead to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a type of corticosteroid and is used to kill myeloma cells. It is used with other drugs to treat multiple myeloma. Giving MeziKD may kill more cancer cells in patients with relapsed/refractory multiple myeloma (RRMM) with EMD.

Key Dates

Start date
May 1, 2025
Status verified
Jan 2026
Primary completion
May 1, 2027
Completion
May 1, 2030

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment - MeziKD
    Patients receive mezigdomide PO QD on days 1-21 of each cycle, carfilzomib IV over 30 minutes on days 1, 8, and 15 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles of study treatment, patients showing a response to therapy may continue the treatment regimen as part of standard of care per physician's discretion. Additionally, patients undergo ECHO, PET/CT, MRI, CT guided tumor biopsy, bone marrow aspiration and biopsy, and blood and saliva sample collection throughout the study,

Primary Outcome Measure

Overall Response Rate [ Time Frame: At the end of cycle 6 (each cycle is 28 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Ask RPCI
[email protected]
800-767-9355
Jens Hillengass (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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