Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00618345|
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : May 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: everolimus Genetic: DNA analysis Genetic: protein analysis Genetic: western blotting Other: flow cytometry Other: laboratory biomarker analysis Procedure: biopsy||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||August 2008|
- Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618345
|Study Chair:||Thomas E. Witzig, MD||Mayo Clinic|
|Principal Investigator:||Rafael Fonseca, MD||Mayo Clinic|
|Principal Investigator:||Roy Vivek, MD||Mayo Clinic|