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

Inclusion Criteria9

  • 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.

Exclusion Criteria16

  • 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.
  • Patients with other commodities that the investigators considered not suitable for the enrollment.

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

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NCT05900882


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