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

Summary

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

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

DRUG

Cxcr1/2 Inhibitor SX-682

Given PO

DRUG

Daratumumab and Recombinant Human Hyaluronidase

Given SC

DRUG

Carfilzomib

Given IV

DRUG

Dexamethasone

Given PO

PROCEDURE

Biospecimen Collection

Undergo Blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo Bone Marrow Aspiration

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Sponsors & Collaborators

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Jens Hillengass, MD · Roswell Park

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-10

Primary Completion

2027-04-10

Completion

2030-04-10

FDA Drug

Yes

Countries

• United States

Study Locations