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New Four-Drug cocktail aims to wipe out Hard-to-Treat myeloma

NCT ID NCT07709884

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests a combination of four drugs—sotoclax, carfilzomib, lenalidomide, and dexamethasone (called SonKRd)—in people newly diagnosed with multiple myeloma that has a specific genetic change called t(11;14). Participants must be healthy enough for a stem cell transplant. The main goal is to see how many patients achieve minimal residual disease (MRD) negativity, meaning no cancer cells can be detected after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of four drugs: sotoclax, carfilzomib, lenalidomide, and dexamethasone
What this could lead to
If successful, this regimen could offer a highly effective first-line treatment for people with this specific genetic subtype of multiple myeloma, potentially leading to deeper and longer-lasting remissions.
What could go wrong
This is a small, single-center study with only 20 participants, so results may not apply to everyone. The combination also carries risks of side effects from the drugs, including infections and organ stress.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosed as active multiple myeloma according to the diagnostic criteria outlined in the "Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2024 Revision)"; 2. Aged 18 or above, male or female; 3. Initial diagnosis of multiple myeloma; 4. The FISH test confirmed by a third-party laboratory is positive for t(11;14) or the previous FISH test report is positive for t(11;14); 5. ECOG score of 0-2; 6. Possessing the following organ function conditions, defined as: HGB\> 80g/dl Platelets \> 50×10\^9/L Neutrophil count \> 1×10\^9/L Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 times ULN; Creatinine clearance rate ≥ 30 mL/min Blood oxygen saturation is ≥90%; 7. Expected survival period is greater than 6 months; The patient understands the purpose and procedures of this trial, voluntarily participates in it, and signs a written informed consent form. Exclusion Criteria: 1. Have received any experimental drug treatment within 2 weeks; 2. Secondary plasma cell leukemia; 3. Transmyocardial amyloidosis with heart failure and arrhythmia; 4. Creatinine clearance rate \< 30 ml/min; 5. Simultaneous presence of other tumors or a history of tumor, or having undergone anti-tumor treatment (including major surgery) within the last 3 weeks, except for the following tumor diseases or those who have been tumor-free for ≥3 years to date: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM clinical stage T1a or T1b), or previously treated prostate cancer; 6. Accompanied by mental illnesses requiring inpatient treatment in psychiatric hospitals or controlled institutions, as well as continuous and frequent outpatient treatment, or exhibiting a dependent cognitive state that cannot be controlled by caregivers (confirmed by a specialist physician); 7. Accompanied by severe pulmonary infection, skin and soft tissue infection, or urinary tract infection; 8. Patients experiencing unstable angina pectoris or myocardial infarction, heart failure NYHA class III or IV, uncontrolled severe coronary artery disease, uncontrolled severe ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or third-degree conduction block within 4 months prior to enrollment, except for those with a cardiac pacemaker; 9. Poorly controlled hypertension or hyperglycemia within 14 days prior to enrollment; 10. Severe, uncontrolled medical disorders or active infections that may impair the subject's ability to receive the treatment specified in the protocol, including but not limited to HIV antibody-positive, syphilis antibody-positive, uncontrolled diabetes, and patients undergoing hemodialysis or peritoneal dialysis; 11. Subjects with uncontrolled active or chronic liver diseases and medical histories (including but not limited to viral hepatitis, cirrhosis, non-alcoholic steatohepatitis) or subjects with significant abnormalities in liver function, or other liver-related diseases that, in the investigator's judgment, may affect drug metabolism or subject safety; 12. Women who are pregnant or breastfeeding 13. Situations where researchers determine that the participant is not suitable for enrollment.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • First Affiliated Hospital, Soochow University

    Suzhou, Jiangsu, 215000, China

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Other studies related to the condition(s) this trial covers.