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

Last updated: August 9, 2023
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer

Lymphoproliferative Disorders

Treatment

Dexamethasone

Bortezomib

Lenalidomide

Clinical Study ID

NCT05900882
SVRd
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 solelyparaskeletal plasmacytoma, plasmacytoma of soft tissue and other special sitesdetected by physical exam and confirmed by CT/MRI/PET-CT and/or biopsy (≥2cm).
  4. ANC≥1.010^9/L, HGB≥7510^9/L, PLT≥50*10^9/L (≥50% of bone marrow nucleated cells areplasma 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 testat screening and all patients agree to use two reliable methods of contraception forsix months after their last dose of medication.
  8. Willingness and ability to comply with scheduled visits, treatment plans, laboratorytests and other study procedures.
  9. Each patient must sign an informed consent form (ICF) indicating that he or sheunderstands the purpose of and procedures required for the study and are willing toparticipate in the study.

Exclusion

Exclusion Criteria:

  1. Patients who have HBV, HCV, and other acquired and congenital immunodeficiencydiseases.
  2. Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according tothe 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 ventriculartachycardia), but patients with first-degree atrioventricular block or asymptomaticleft anterior bundle/right fascicular block cannot be excluded. c. New York HeartAssociation (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 basalcarcinoma 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 disorderswho are unable to understand or adhere to the study protocol.
  12. According to the study protocol or in the opinion of the investigator,serious physicalor mental illness that is likely to interfere with the study procedures/results.
  13. Any psychological, familial, sociological and geographical condition potentiallyhampering 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 theenrollment.

Study Design

Total Participants: 35
Treatment Group(s): 4
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
July 15, 2022
Estimated Completion Date:
June 30, 2025

Study Description

Study Design:

This protocol corresponds to a multicenter, open-label, single arm, exploratory study designed to determine the safety of the combination of selinexor combined with VRd in NDMM patients presenting with EMD. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation or no ASCT and followed by consolidation and maintenance treatment.

All patients will receive 4 courses of SVRd induction therapy, each cycle of treatment will compromise 4 weeks of Selinexor 60mg QW treatment. Transplantation could be performed after 2 courses of VRd consolidation therapy. If not receive transplantation will give 4 cycles of SVRd consolidation therapy. Maintenance treatment will continued for a maximum of 2 years.

Study design allows 35 patients. Induction treatment will consist of Selinexor 60 mg/day orally on d1,8,15,22, Bortezomib 1.3mg/m2 intravenously on d1,8,15,22, Lenalidomide 25 mg/d ( the dose will be adjusted according to creatinine clearance), orally on days 1 to14, Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Connect with a study center

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Nanjing First People's Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226001
    China

    Site Not Available

  • Taizhou People's Hospital

    Taizhou, Jiangsu 225300
    China

    Site Not Available

  • Yancheng First People's Hospital

    Yancheng, Jiangsu 224006
    China

    Site Not Available

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