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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05900882
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor 60 mg/day, orally on d1,8,15,22
  • Bortezomib — DRUG
    Bortezomib 1.3mg/m2 intravenously on d1,8,15,22
  • Lenalidomide — DRUG
    Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)
  • Dexamethasone — DRUG
    Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Study Details

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

Key Dates

Start date
Jul 15, 2022
Status verified
Aug 2024
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: study group
    SVRd induction treatment

Primary Outcome Measure

Number of Participants With Overall Response Rate (ORR) [ Time Frame: End of induction treatment (4 cycles, each cycle is 28 days) ]

Central Contacts

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