Can a Four-Drug cocktail tackle Hard-to-Treat myeloma spread?

NCT ID NCT05900882

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This phase 2 trial tests a combination of four drugs, selinexor, bortezomib, lenalidomide, and dexamethasone (SVRd), in people newly diagnosed with multiple myeloma whose disease has spread outside the bone marrow, called extramedullary disease. The study aims to see how well this regimen shrinks or eliminates the cancer and how safe it is. Participants receive the drugs in cycles, with doses adjusted as needed. The main goal is to measure the overall response rate, meaning the proportion of patients who achieve at least a partial remission.

What this could mean

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

Active substance
A four-drug combination: selinexor, bortezomib, lenalidomide, and dexamethasone
What this could lead to
If it works, this could offer a more effective first-line treatment option for multiple myeloma patients whose disease has spread outside the bone marrow, a group with poor outcomes.
What could go wrong
This is a small, early-phase exploratory study with only 29 participants, so results may not apply broadly. The drugs can cause significant side effects, including low blood counts and infections.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Jul 2022

Finished

Aug 2026

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 to 75 years

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. Men and women aged with18-75 years old. 2. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines) 3. Newly diagnosed patients presenting with extramedullary disease (EMD) including solely paraskeletal plasmacytoma, plasmacytoma of soft tissue and other special sites detected by physical exam and confirmed by CT/MRI/PET-CT and/or biopsy (≥2cm). 4. ANC≥1.0\*10\^9/L, HGB≥75\*10\^9/L, PLT≥50\*10\^9/L (≥50% of bone marrow nucleated cells are plasma cells). 5. Patients whose expecting survival time will be more than 3 months. 6. Without active infectious disease. 7. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and all patients agree to use two reliable methods of contraception for six months after their last dose of medication. 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. 9. Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: 1. Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases. 2. Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0. 3. Plasma cell leukemia. 4. Serious thrombotic events. 5. Active, unstable cardiovascular dysfunction: a. symptomatic ischemia; b. Uncontrolled, clinically significant conduction abnormalities (except antiarrhythmic ventricular tachycardia), but patients with first-degree atrioventricular block or asymptomatic left anterior bundle/right fascicular block cannot be excluded. c. New York Heart Association (NYHA) Class III - IV or left ventricular ejection fraction (LVEF) \<40%; d. Myocardial infarction Within 3 months before C1D1. 6. Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)). 7. Serum bilirubin≥1.5 × ULN. 8. creatinine clearance \<30 ml/min. 9. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma. 10. Previous major operation within 30 days before C1D1. 11. Patients who have epilepsy, dementia requiring medication, or other mental disorders who are unable to understand or adhere to the study protocol. 12. According to the study protocol or in the opinion of the investigator,serious physical or mental illness that is likely to interfere with the study procedures/results. 13. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 14. Current participation in another clinical trial. 15. Pregnant or lactating women. 16. Patients with other commodities that the investigators considered not suitable for the enrollment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Contacts and locations

Locations

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001, China

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu, 213000, China

  • Nanjing First People's Hospital

    Nanjing, Jiangsu, 210000, China

  • Taizhou People's Hospital

    Taizhou, Jiangsu, 225300, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029, China

  • Yancheng First People's Hospital

    Yancheng, Jiangsu, 224006, China

More trials for these conditions

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