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Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
everolimus
DNA analysis
protein analysis
western blotting
flow cytometry
laboratory biomarker analysis
biopsy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein

    Secondary Outcome Measures

    Toxicity

    Full Information

    First Posted
    February 19, 2008
    Last Updated
    May 13, 2011
    Sponsor
    Mayo Clinic
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00618345
    Brief Title
    Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
    Official Title
    Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mayo Clinic
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma and Plasma Cell Neoplasm
    Keywords
    refractory multiple myeloma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    everolimus
    Intervention Type
    Genetic
    Intervention Name(s)
    DNA analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    protein analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    western blotting
    Intervention Type
    Other
    Intervention Name(s)
    flow cytometry
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Type
    Procedure
    Intervention Name(s)
    biopsy
    Primary Outcome Measure Information:
    Title
    Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
    Secondary Outcome Measure Information:
    Title
    Toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas E. Witzig, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Rafael Fonseca, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Roy Vivek, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

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