Selinexor and Lenalidomide for Consolidation and Maintenance Treatment in Multiple Myeloma Post-transplant

Sponsor
Washington University School of Medicine
Study ID
NCT05820763
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor is administered by mouth on Days 1, 8, 15, and 22 at a dose of 60 mg during the four cycles of consolidation. Selinexor is then decreased to 40 mg and administered by mouth on Days 1, 8, 15, and 22 for up to 8 cycles of maintenance therapy.
  • Lenalidomide — DRUG
    Lenalidomide is administered by mouth daily on Days 1 to 21 at a dose of 10 mg during the first three cycles of consolidation, and then titrated up to 15 mg on Days 1 to 21 for the fourth cycle of consolidation. Lenalidomide 15 mg by mouth daily on Days 1 to 21 can be continued for up to 8 cycles of maintenance therapy. For patients with baseline renal dysfunction, the starting dose of lenalidomide will be 2.5 mg or 5 mg by mouth daily on Days 1 to 21. Patients may titrate up per physician discretion.
  • Dexamethasone — DRUG
    Dexamethasone is administered by mouth on Days 1, 8, 15, and 22 at a dose of 20 mg during all four cycles of consolidation only.

Study Details

This phase II clinical trial studies the addition of selinexor to lenalidomide in patients with multiple myeloma following transplant. Selinexor is an oral medication approved for use in patients with multiple myeloma following failure of other regimens, and lenalidomide is an oral medication approved for use in patients with multiple myeloma following transplant. This study is testing if the combination of selinexor and lenalidomide is more effective than lenalidomide alone in this setting.

Key Dates

Start date
Jan 5, 2024
Status verified
Jul 2024
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Consolidation: Selinexor, Lenalidomide, and Dexamethasone
    Consolidation will begin between Days 80 and 140 following standard of care autologous hematopoietic stem cell transplant and the treatment will consist of selinexor, lenalidomide, and dexamethasone for 4 28-day cycles.
  • Experimental: Maintenance: Selinexor and Lenalidomide
    Maintenance will consist of selinexor and lenalidomide for a maximum of 8 28-day cycles.

Primary Outcome Measure

Rate of Minimal Residual Disease (MRD) negativity [ Time Frame: At the end of consolidation treatment (at the end of 4 cycles (each cycle is 28 days) ]

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