SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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)
1 other identifier
interventional
15
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2025
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 10, 2030
April 21, 2026
April 1, 2026
2 years
September 30, 2024
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
WIthin the first 28 days of start of treatment
Secondary Outcomes (4)
Percentage of Overall response rate
Up to 3 years after last patient is enrollled
Percentage of Progression-free survival
Up to 3 years after last patient is enrolled
Percentage of Overall Survival
Up to 3 years after last patient is enrolled
Incidence of Adverse Events (AE's_
Within the first 6 months of treatment
Study Arms (1)
Treatment
EXPERIMENTALPatients receive SX-682 PO BID on days 1-21 of each cycle. Patients also receive daratumumab-hyaluronidase SC once weekly on cycles 1 and 2 and once every 2 weeks on cycles 3-6 and carfilzomib IV on days 1, 8 and 15 and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with sustained response after 6 cycles may continue to receive SX-682 PO BID on days 1-21, daratumumab-hyaluronidase SC on day 1, carfilzomib IV on days 1, 8, and 15 and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, BM aspiration, ECHO and PET/CT or MRI on study.
Interventions
Given SC
Given PO
Eligibility Criteria
You may qualify if:
- Confirmed relapsed/ refractory multiple myeloma
- Measurable disease including at least one of the following criteria:
- 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
- Bone marrow plasma cells ≥ 10% total bone marrow cells
- ≥ 1 prior line of therapy
- Planned treatment with a carfilzomib/daratumumab/dexamethasone regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count: ≥ 3 x 10\^9/L
- Platelets: ≥ 75 x 10\^9/L
- Hemoglobin: ≥ 7 g/dL
- Total bilirubin: ≤ 1.5 x upper limit of normal (ULN): ≤ 3.0 x ULN for Gilbert's syndrome
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 x ULN
- Renal Function: Estimated creatinine clearance ≥ 45 mL/min (Cockroft-Gault)
- +3 more criteria
You may not qualify if:
- 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)
- Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, or (b) QT prolonging as defined in the drug's approved label, with the exception of drugs that are considered absolutely essential for the care of the subject or if the investigator believes that beginning therapy with such medication is vital to an individual subject's care while on study, and in either case, there is no alternative medication
- Electrocardiogram (ECG) demonstrating a corrected QT (QTc) interval \> 470 msec or patients with congenital long QT syndrome
- Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, class III or IV heart failure (New York Heart Association functional classification system) or psychiatric illness/social situations that would limit compliance with study requirements
- History of hepatitis B, C or HIV
- Known active bacillus tuberculosis infection
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Hillengass, MD
Roswell Park
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 1, 2024
Study Start
April 10, 2025
Primary Completion (Estimated)
April 10, 2027
Study Completion (Estimated)
April 10, 2030
Last Updated
April 21, 2026
Record last verified: 2026-04