RECRUITING

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

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Conditions

Recurrent Multiple MyelomaRefractory Multiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2025-04-01
Study Completion:2030-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06622005

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed relapsed/ refractory multiple myeloma
  2. * Measurable disease including at least one of the following criteria:
  3. * Serum M-protein ≥ 0.5 g/dL
  4. * Urine M-protein ≥ 200 mg/24h
  5. * 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
  6. * Bone marrow plasma cells ≥ 10% total bone marrow cells
  7. * ≥ 1 prior line of therapy
  8. * Planned treatment with a carfilzomib/daratumumab/dexamethasone regimen
  9. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  10. * Absolute neutrophil count: ≥ 3 x 10\^9/L
  11. * Platelets: ≥ 75 x 10\^9/L
  12. * Hemoglobin: ≥ 7 g/dL
  13. * Total bilirubin: ≤ 1.5 x upper limit of normal (ULN): ≤ 3.0 x ULN for Gilbert's syndrome
  14. * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 x ULN
  15. * Renal Function: Estimated creatinine clearance ≥ 45 mL/min (Cockroft-Gault)
  16. * Left ventricular ejection fraction of at least 50%
  17. * 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
  18. * 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
  1. * Patients with non-secretory myeloma, systemic light chain amyloidosis or, plasmacytoma
  2. * Intolerance to SX-682 or any other of the treatment components
  3. * Refractory to prior carfilzomib (i.e. relapse or progression on or within 60 days after completion of treatment)
  4. * Refractory to prior daratumumab (i.e. relapse or progression on or within 60 days after completion of treatment)
  5. * 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
  6. * Electrocardiogram (ECG) demonstrating a corrected QT (QTc) interval \> 470 msec or patients with congenital long QT syndrome
  7. * Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months
  8. * 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
  9. * History of hepatitis B, C or HIV
  10. * Known active bacillus tuberculosis infection
  11. * Pregnant or nursing female participants
  12. * Unwilling or unable to follow protocol requirements
  13. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Contacts and Locations

Study Contact

ASK RPCI
CONTACT
1-877-275-7724
askrpcil@roswellpark.org

Principal Investigator

Jens Hillengass, MD
PRINCIPAL_INVESTIGATOR
Roswell Park

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Jens Hillengass, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-04-01
Study Completion Date2030-04-01

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2030-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma