RecruitingPhase 2NCT05900882

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting 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.


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

35 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — selinexor, bortezomib, and dexamethasone (SVRd) — for people newly diagnosed with multiple myeloma (a blood cancer) that has formed tumors outside the bone marrow, known as extramedullary disease. **You may be eligible if...** - You are between 18 and 75 years old - You have a new diagnosis of multiple myeloma with tumors outside the bone marrow confirmed by imaging or biopsy - Your blood counts are adequate - You do not have active infections - You are willing and able to follow the study schedule, and are using reliable contraception if applicable **You may NOT be eligible if...** - You have previously received treatment for multiple myeloma - You have serious heart, lung, liver, or kidney disease - You are pregnant or breastfeeding - You have active infections or recent bleeding - You have had a recent blood clot, stroke, or brain bleed in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor

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

DRUGBortezomib

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

DRUGLenalidomide

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

DRUGDexamethasone

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


Locations(6)

Changzhou Second People's Hospital

Changzhou, Jiangsu, China

Nanjing First People's Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Taizhou People's Hospital

Taizhou, Jiangsu, China

Yancheng First People's Hospital

Yancheng, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT05900882


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