About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed relapsed/ refractory multiple myeloma
Serum M-protein ≥ 0.5 g/dL
Urine M-protein ≥ 200 mg/24h
Serum free light chain assay: involved free light chain (FLC) level greater or equal to 100 mg/L provided serum free light chain ratio is abnormal
Disqualifiers
Patients with non-secretory myeloma, systemic light chain amyloidosis or, plasmacytoma
Intolerance to SX-682 or any other of the treatment components
Refractory to prior carfilzomib (i.e. relapse or progression on or within 60 days after completion of treatment)
Refractory to prior daratumumab (i.e. relapse or progression on or within 60 days after completion of treatment)
Trial design
Single group
Treatments tested in this trial
Cxcr1/2 Inhibitor SX-682
DrugGiven PO
Daratumumab and Recombinant Human Hyaluronidase
DrugGiven SC
Carfilzomib
DrugGiven IV
Dexamethasone
DrugGiven PO
Biospecimen Collection
Procedure/SurgeryUndergo Blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo Bone Marrow Aspiration
Echocardiography
Procedure/SurgeryUndergo ECHO
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Percentage of Overall response rate
Obtained using Jeffrey's prior method
Percentage of Progression-free survival
Determined using Kaplan-Meier estimates
Percentage of Overall Survival
Determined using Kaplan-Meier estimates
Incidence of Adverse Events (AE's_
AE's will be grading using CTCAE v.5.
Sponsors and contacts
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