Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT07082270
Phase
PHASE1
Status
Withdrawn

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 blood sample collection
  • 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
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Selvigaltin — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of selvigaltin when given together with standard of care treatment (daratumumab-hyaluronidase, carfilzomib, dexamethasone) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Selvigaltin works by blocking the activity of a protein called galectin-3. Galectin-3 is involved in various cellular processes, including inflammation and tissue scarring, which is associated with worse outcomes in several forms of cancer. By blocking the activity of galectin-3, selvigaltin may help reduce inflammation and tissue scarring. Daratumumab-hyaluronidase is a drug composed of daratumumab and hyaluronidase. 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. Hyaluronidase helps deliver the daratumumab to CD38-expressing cancer cells. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (selvigaltin, Dara-KD)
    See Detailed Description.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NY

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