NCT05820763

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

A Phase II Study of Selinexor In Addition to Lenalidomide for Consolidation and Maintenance Treatment After Autologous Hematopoietic Cell Transplant in Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Myeloma
• Myeloma-Associated Amyloidosis

Interventions

Type	Name	Description
DRUG	Selinexor	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.
DRUG	Lenalidomide	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.
DRUG	Dexamethasone	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.

Timeline

• Start date: 2024-01-05
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2023-04-20
• Last updated: 2024-07-10

Regulatory

• FDA-regulated drug study