Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
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
Arms & interventions
- DrugCxcr1/2 Inhibitor SX-682
Given PO
- DrugDaratumumab and Recombinant Human Hyaluronidase
Given SC
- DrugCarfilzomib
Given IV
- DrugDexamethasone
Given PO
- ProcedureBiospecimen Collection
Undergo Blood sample collection
- ProcedureBone Marrow Aspiration
Undergo Bone Marrow Aspiration
- ProcedureEchocardiography
Undergo ECHO
- ProcedurePositron Emission Tomography
Undergo PET/CT
- ProcedureComputed Tomography
Undergo PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Outcome measures
Primary
Incidence of dose-limiting toxicity
Dose limiting toxicities will be summarized using frequencies and relative frequencies. Estimates of the dose-limiting toxicity rates will be obtained with 90% credible regions obtained by Jeffrey's prior method. The summary will be performed by dose level, if applicable.
Time frame: WIthin the first 28 days of start of treatment
Secondary
Percentage of Overall response rate
Time frame: Up to 3 years after last patient is enrollled
Percentage of Progression-free survival
Time frame: Up to 3 years after last patient is enrolled
Percentage of Overall Survival
Time frame: Up to 3 years after last patient is enrolled
Incidence of Adverse Events (AE's_
Time frame: Within the first 6 months of treatment
Eligibility criteria
Study locations (1)
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263