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Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618345
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : May 16, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Brief 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.

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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Everolimus

Primary Outcome Measures :
  1. Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein

Secondary Outcome Measures :
  1. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of multiple myeloma, meeting 1 of the following criteria:

    • Monoclonal protein in the serum of ≥ 1 g/dL
    • Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours
    • Measurable light chains by free light chain assay of ≥ 10 mg/dL
    • Measurable plasmacytoma
  • Must have received prior therapy and have relapsed or refractory disease


  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)
  • AST ≤ 3 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • Calcium < 11 mg/dL
  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity


  • See Disease Characteristics
  • At least 3 weeks since prior cytotoxic chemotherapy
  • At least 2 weeks since prior biologic therapy or radiotherapy
  • At least 2 weeks since prior corticosteroids

    • Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma
  • No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational

Information from the National Library of Medicine

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 identifier (NCT number): NCT00618345

Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: Thomas E. Witzig, MD Mayo Clinic
Principal Investigator: Rafael Fonseca, MD Mayo Clinic
Principal Investigator: Roy Vivek, MD Mayo Clinic

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Responsible Party: Thomas E. Witzig, M.D., The Mayo Clinic Identifier: NCT00618345     History of Changes
Other Study ID Numbers: CDR0000582257
P30CA015083 ( U.S. NIH Grant/Contract )
MC048E ( Other Identifier: Mayo Clinic Cancer Center )
96-05 ( Other Identifier: Mayo Clinic IRB )
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011
Keywords provided by Mayo Clinic:
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents