SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

April 16, 2026 updated by: Roswell Park Cancer Institute

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • Left ventricular ejection fraction of at least 50%
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months following the last dose of the investigational drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Participant must understand the investigational nature of this study and sign an Independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Patients 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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI Scan
Drug: Dexamethasone
Given PO
Other Names:
  • Adexone
  • Baycadron
  • Cortidexason
  • Decadrol
  • Fluorodelta
  • Loverine
Procedure: Echocardiography
Undergo ECHO
Other Names:
  • EC
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT Scan
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • PET
  • PET Scan
Drug: Carfilzomib
Given IV
Other Names:
  • CFZ
  • PR 171
Drug: Daratumumab and Recombinant Human Hyaluronidase
Given SC
Other Names:
  • Daratumumab and hyaluronidase
Drug: Cxcr1/2 Inhibitor SX-682
Given PO
Other Names:
  • SX-682
Procedure: Biospecimen Collection
Undergo Blood sample collection
Procedure: Bone Marrow Aspiration
Undergo Bone Marrow Aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicity
Time Frame: WIthin the first 28 days of start of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Overall response rate
Time Frame: Up to 3 years after last patient is enrollled
Obtained using Jeffrey's prior method
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
Determined using Kaplan-Meier estimates
Up to 3 years after last patient is enrolled
Percentage of Overall Survival
Time Frame: Up to 3 years after last patient is enrolled
Determined using Kaplan-Meier estimates
Up to 3 years after last patient is enrolled
Incidence of Adverse Events (AE's_
Time Frame: Within the first 6 months of treatment
AE's will be grading using CTCAE v.5.
Within the first 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Jens Hillengass, MD, Roswell Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

April 10, 2027

Study Completion (Estimated)

April 10, 2030

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-3850824

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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