SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06622005
Phase
PHASE1
Status
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

  • Cxcr1/2 Inhibitor SX-682 — DRUG
    Given PO
  • Daratumumab and Recombinant Human Hyaluronidase — DRUG
    Given SC
  • Carfilzomib — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo Blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo Bone Marrow Aspiration
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become "free" to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells through a subcutaneous injection. Dexamethasone is in a class of medications called corticosteroids. It is known to kill myeloma cells and is also used to reduce inflammation and lower the body's immune response to monoclonal antibodies like dratumumab and help lessen its side effects. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma

Key Dates

Start date
Apr 10, 2025
Status verified
Apr 2026
Primary completion
Apr 10, 2027
Completion
Apr 10, 2030

Study Design

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

Arms

  • Experimental: Treatment
    Patients receive SX-682 PO BID on days 1-21 of each cycle. Patients also receive daratumumab-hyaluronidase SC once weekly on cycles 1 and 2 and once every 2 weeks on cycles 3-6 and carfilzomib IV on days 1, 8 and 15 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. Patients with sustained response after 6 cycles may continue to receive SX-682 PO BID on days 1-21, daratumumab-hyaluronidase SC on day 1, carfilzomib IV on days 1, 8, and 15 and dexamethasone PO 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 blood sample collection, BM aspiration, ECHO and PET/CT or MRI on study.

Primary Outcome Measure

Incidence of dose-limiting toxicity [ Time Frame: WIthin the first 28 days of start of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-

Find similar trials in Buffalo, NY

By research site
Roswell Park Comprehensive Cancer Center· Buffalo, NY

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