SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

NCT05900882 | Recruiting Phase 2

• 1 other identifier: SVRd
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.

Conditions

Multiple Myeloma

Keywords

NDMM; Extramedullary disease; SVRd

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Response Rate (ORR)

  ORR: defined as the proportion of patients who will achieve PR or better, as per IMWG criteria.

  End of induction treatment (4 cycles, each cycle is 28 days)

Secondary Outcomes (5)

• Number of Participants With Complete Response Rate (CR)

  End of induction treatment (4 cycles, each cycle is 28 days)

• Duration of Response (DOR)

  5 years

• Progression-Free Survival (PFS)

  5 years

• Overall Survival (OS)

  5 years

• Number of adverse events

  During of induction treatment (4 cycles, each cycle is 28 days)

Study Arms (1)

study group

EXPERIMENTAL

SVRd induction treatment

Drug: Selinexor; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Selinexor DRUG

Selinexor 60 mg/day, orally on d1,8,15,22

Also known as: S

study group

Bortezomib DRUG

Bortezomib 1.3mg/m2 intravenously on d1,8,15,22

Also known as: V

study group

Lenalidomide DRUG

Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)

Also known as: R

study group

Dexamethasone DRUG

Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Also known as: d

study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged with18-75 years old.
• Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
• 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).
• 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).
• Patients whose expecting survival time will be more than 3 months.
• Without active infectious disease.
• 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.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
• 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.

You may not qualify if:

• Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases.
• Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0.
• Plasma cell leukemia.
• Serious thrombotic events.
• 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.
• Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)).
• Serum bilirubin≥1.5 × ULN.
• creatinine clearance \<30 ml/min.
• History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma.
• Previous major operation within 30 days before C1D1.
• Patients who have epilepsy, dementia requiring medication, or other mental disorders who are unable to understand or adhere to the study protocol.
• 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.
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Current participation in another clinical trial.
• Pregnant or lactating women.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (6)

Changzhou Second People's Hospital

Changzhou, Jiangsu, 213000, China

NOT YET RECRUITING

Nanjing First People's Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

NOT YET RECRUITING

Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

NOT YET RECRUITING

Yancheng First People's Hospital

Yancheng, Jiangsu, 224006, China

NOT YET RECRUITING

Related Publications (1)

• Jin Y, Cheng X, Zhang X, Shi Q, Zhu Y, Li J, Fan L, Chen L. Efficacy and Safety of Selinexor Combined with VRD in Newly Diagnosed Multiple Myeloma with EMD: A Phase 2 Trial. Blood Adv. 2026 Jan 21:bloodadvances.2025018945. doi: 10.1182/bloodadvances.2025018945. Online ahead of print.

  PMID: 41564431 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

selinexor; Bortezomib; Lenalidomide; Dexamethasone; Fumigant 93

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Lijuan Chen

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Yuanyuan Jin, Doctor

CONTACT

025-83714511; 827508088@qq.com

Lijuan Chen, Doctor

CONTACT

025-83714511; chenljb@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 13, 2023
• Study Start: July 15, 2022
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 17, 2025

Record last verified: 2024-08

Locations

CN (6)