New drug combo aims to boost immune attack on Hard-to-Treat myeloma
NCT ID NCT06622005
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This early-phase trial tests whether adding an experimental drug called SX-682 to a standard three-drug regimen is safe for people with multiple myeloma that has relapsed or become resistant. SX-682 works by freeing up immune cells to better kill cancer cells. The study will enroll about 15 participants and closely monitor side effects and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SX-682 (a drug that blocks certain immune cell signals) combined with carfilzomib, daratumumab-hyaluronidase, and dexamethasone
- What this could lead to
- If successful, this could point toward a new combination treatment option for patients with multiple myeloma that has returned or not responded to prior therapy.
- What could go wrong
- This is a very early (Phase 1) trial with only 15 participants, so the main goal is safety, not effectiveness. The combination may cause side effects or fail to control the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: ≥ 1.5 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Comprehensive Cancer Center
RECRUITINGBuffalo, New York, 14263, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Engineered donor cells could outsmart relapsed myeloma
- Can a Triple-Drug cocktail tame resistant myeloma?
- Can a One-Two drug punch beat back Hard-to-Treat myeloma?
- CAR-T breakthroughs come with infection risks – new study aims to decode them
- Double-barreled CAR t therapy takes aim at hard-to-treat myeloma
- Can a drug stop dangerous side effects of new myeloma therapies?