Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma
- To assess the response rate in patients with relapsed or refractory multiple myeloma
treated with everolimus.
- 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
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
After completion of study treatment, patients are followed every 3-6 months for up to 2
Masking: Open Label, Primary Purpose: Treatment
Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
Thomas E. Witzig, MD
United States: Food and Drug Administration