Actively Recruiting
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
Led by Roswell Park Cancer Institute · Updated on 2026-04-21
15
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and side effects of an investigational drug called SX-682 when combined with standard treatments carfilzomib, daratumumab-hyaluronidase, and dexamethasone in patients with relapsed or refractory multiple myeloma. This is a phase 1 trial focused on patients whose disease has returned or not responded to previous therapies. SX-682 is designed to help the immune system better attack tumor cells by blocking specific sites that suppress immune activity, while the other drugs work by stopping tumor growth and supporting immune response. Participants receive SX-682 by mouth twice daily on days 1 through 21 of each 28-day cycle. They also receive daratumumab-hyaluronidase as a subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three through six. Carfilzomib is given intravenously on days 1, 8, and 15, and dexamethasone is taken orally on days 1, 8, 15, and 22 of each cycle. Treatment cycles may continue up to six cycles if tolerated without disease progression, and patients with sustained response may continue these medications on the same schedule. During the study, participants undergo blood sample collection, bone marrow aspiration, echocardiograms, and imaging scans such as PET/CT or MRI to monitor their condition. Researchers measure side effects including dose-limiting toxicity in the first 28 days, as well as overall response, progression-free survival, overall survival, and adverse events over time. The trial aims to assess the safety of this drug combination and its effects on the disease over a follow-up period extending up to three years after the last patient enrollment.
CONDITIONS
Brief 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 ≥ 0.5 g/dL, urine M-protein ≥ 200 mg/24h, involved free light chain level ≥ 100 mg/L with abnormal ratio, or bone marrow plasma cells ≥ 10%
- At least 1 prior line of therapy
- Planned treatment with carfilzomib, daratumumab, and dexamethasone
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count ≥ 3 x 10^9/L
- Platelets ≥ 75 x 10^9/L
- Hemoglobin ≥ 7 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (≤ 3.0 times for Gilbert's syndrome)
- AST and ALT ≤ 3 times upper limit of normal
- Estimated creatinine clearance ≥ 45 mL/min
- Left ventricular ejection fraction of at least 50%
- Use of effective contraception before and for 6 months after treatment if of childbearing potential
- 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 medications strongly affecting CYP3A4 or causing QT prolongation unless essential
- ECG showing corrected QT interval over 470 msec or congenital long QT syndrome
- Recent (within 6 months) serious heart conditions such as bypass, angioplasty, myocardial infarction, angina, or heart failure
- Uncontrolled illness including active infection, severe heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- History of hepatitis B, C, or HIV
- Active tuberculosis infection
- Pregnant or nursing women
- Unwillingness or inability to follow study protocol
- Any condition making the participant unsuitable for study drug per investigator's judgment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each, with possible extension
Participants receive SX-682 orally twice daily on days 1-21 of each 28-day cycle. They also receive daratumumab-hyaluronidase subcutaneously once weekly during cycles 1 and 2 and once every two weeks during cycles 3 to 6. Carfilzomib is given intravenously on days 1, 8, and 15, and dexamethasone is given orally on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 6 cycles unless disease progresses or toxicity occurs. Participants with sustained response after 6 cycles may continue treatment with the same schedule.
Weekly visits during cycles 1 and 2; visits every 2 weeks during cycles 3 to 6; visit frequency may vary in extension phase
Duration - Throughout the treatment period
Participants undergo blood sample collection, bone marrow aspiration, echocardiography, and PET/CT or MRI scans as part of the study assessments during treatment.
Assessments occur periodically during treatment visits
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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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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