NCT02086552

Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 2 Trial of LDE225 and Lenalidomide Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well sonidegib and lenalidomide after stem cell transplant works in treating patients with multiple myeloma. Sonidegib and lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay multiple myeloma from coming back after a stem cell transplant.

Detailed description

PRIMARY OBJECTIVES: I. To assess the complete response (CR) rate with lenalidomide and sonidegib (LDE225) maintenance following an upfront single autologous stem cell transplant (SCT). SECONDARY OBJECTIVES: I. To assess the toxicity of lenalidomide and LDE225 when used as maintenance therapy in patients post autologous SCT. II. To determine the progression-free survival rate at 1 and 2 years post autologous SCT. III. To evaluate progression-free survival and overall survival. TERTIARY OBJECTIVES: I. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status. OUTLINE: Patients receive sonidegib orally (PO) once daily (QD) on days 1-28 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stringent complete response (sCR), CR, very good partial response (VGPR), partial response (PR), minor response (MR), or stable disease (SD) (or unconfirmed \[u\]sCR, uCR, uVGPR, uPR, uMR) continue treatment in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 90 days for up to 3 years.

Conditions

• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO
DRUG	Sonidegib	Given PO

Timeline

• Start date: 2014-01-17
• Primary completion: 2018-01-15
• Completion: 2021-08-13
• First posted: 2014-03-13
• Last updated: 2021-12-03
• Results posted: 2019-05-29

Locations

1 site across 1 country: United States