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

Launched by ROSWELL PARK CANCER INSTITUTE · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with multiple myeloma, a type of blood cancer that has either come back after treatment or has not responded to earlier therapies. The trial is testing a drug called SX-682 combined with standard treatments: carfilzomib, daratumumab-hyaluronidase, and dexamethasone. SX-682 helps the immune system recognize and destroy tumor cells more effectively. The goal is to see if this combination is safe and tolerable for patients and to understand how well it works in managing their cancer.

To be eligible for the trial, participants need to have confirmed multiple myeloma that is either relapsed or refractory (meaning it hasn’t responded to treatment before). They should have measurable disease and have received at least one prior therapy. Participants will be closely monitored during the trial and will receive the new treatment along with standard care. It's important for potential participants to discuss with their doctors about the trial and understand the requirements, including any necessary tests to ensure they qualify. This study is currently recruiting patients of all genders aged 65 and older.

Gender

ALL

Eligibility criteria

• 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