Actively Recruiting
SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Led by Roswell Park Cancer Institute · Updated on 2026-04-21
15
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed relapsed or refractory multiple myeloma
- Measurable disease with at least one of the following: serum M-protein 63 0.5 g/dL, urine M-protein 63 200 mg/24h, involved free light chain level 63 100 mg/L with abnormal ratio, or 63 10% bone marrow plasma cells
- At least 1 prior line of therapy
- Planned treatment with carfilzomib, daratumumab, and dexamethasone regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count 63 3 x 10^9/L
- Platelets 63 75 x 10^9/L
- Hemoglobin 63 7 g/dL
- Total bilirubin 64 1.5 x upper limit of normal (ULN), or 64 3.0 x ULN for Gilbert's syndrome
- AST/ALT 64 3 x ULN
- Estimated creatinine clearance 63 45 mL/min
- Left ventricular ejection fraction of at least 50%
- Participants of child-bearing potential must agree to use contraception during and for 6 months after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Non-secretory myeloma, systemic light chain amyloidosis, or plasmacytoma
- Intolerance to SX-682 or any treatment components
- Refractory to prior carfilzomib or daratumumab (relapse or progression within 60 days after treatment)
- Use of strong CYP3A4 inhibitors/inducers or QT prolonging drugs unless essential
- ECG showing corrected QT interval > 470 msec or congenital long QT syndrome
- Recent (within 6 months) coronary artery bypass, angioplasty, stent, myocardial infarction, angina, or congestive heart failure
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or severe psychiatric illness
- History of hepatitis B, hepatitis C, or HIV
- Active tuberculosis infection
- Pregnant or nursing females
- Unable or unwilling to follow protocol requirements
- Any condition making participant unsuitable for study drug in investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
A
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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