NCT00618345

Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.

Detailed description

OBJECTIVES: Primary * To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus. Secondary * To evaluate the toxicity of everolimus in patients with multiple myeloma. * To study the tumor cells and blood from patients entering this trial for laboratory correlates. OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density. After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	everolimus
GENETIC	DNA analysis
GENETIC	protein analysis
GENETIC	western blotting
OTHER	flow cytometry
OTHER	laboratory biomarker analysis
PROCEDURE	biopsy

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-10-01
• Completion: 2008-08-01
• First posted: 2008-02-20
• Last updated: 2011-05-16