Can a Four-Drug cocktail tackle Hard-to-Treat myeloma spread?
NCT ID NCT05900882
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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29 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Aug 2026
- 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 to 75 years
- 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: 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.
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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.
Contacts and locations
Locations
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Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
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Changzhou Second People's Hospital
Changzhou, Jiangsu, 213000, China
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Nanjing First People's Hospital
Nanjing, Jiangsu, 210000, China
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Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
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Yancheng First People's Hospital
Yancheng, Jiangsu, 224006, China
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