Treatment for newly diagnosed multiple myeloma patients with extramedullary disease

An Open Label, Single Arm, Multi-Center Exploratory Study to Evaluate the Efficacy and Safety of SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease.

This study is testing a new combination treatment for people with newly diagnosed multiple myeloma and extramedullary disease to see if it helps them feel better and improves their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 6 sites (Changzhou, Jiangsu and 5 other locations)
• Trial ID: NCT05900882 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a combination treatment involving selinexor, bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma who present with extramedullary disease. It is a multicenter, open-label, single-arm exploratory study that includes 35 patients. Participants will receive four courses of induction therapy followed by potential allogeneic hematopoietic stem cell transplantation or consolidation therapy, with maintenance treatment lasting up to two years. The study aims to assess the response to this treatment regimen and its impact on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18-75 with a confirmed diagnosis of multiple myeloma and presenting with extramedullary disease.

Not a fit: Patients with active infectious diseases or those whose expected survival time is less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with newly diagnosed multiple myeloma and extramedullary disease.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in treating multiple myeloma, though this specific combination is novel.

Eligibility criteria

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.

Where this trial is running

Changzhou, Jiangsu and 5 other locations

• Changzhou Second People's Hospital — Changzhou, Jiangsu, China (Not_yet_recruiting)
• Nanjing First People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
• Taizhou People's Hospital — Taizhou, Jiangsu, China (Not_yet_recruiting)
• Yancheng First People's Hospital — Yancheng, Jiangsu, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yuanyuan Jin, Doctor

Conditions Multiple Myeloma; NDMM; Extramedullary disease; SVRd