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New treatment option for Recurrent Multiple Myeloma
Official title SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06622005
What this study is testing
What is Cxcr1/2 Inhibitor SX-682?
Cxcr1/2 Inhibitor SX-682 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for recurrent multiple myeloma.
Also referred to as SX-682.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Electrocardiogram (ECG) demonstrating a corrected QT (QTc) interval \> 470 msec or patients with congenital long QT syndrome
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.