Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

May 13, 2011 updated by: Mayo Clinic

Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Thomas E. Witzig, MD, Mayo Clinic
  • Principal Investigator: Rafael Fonseca, MD, Mayo Clinic
  • Principal Investigator: Roy Vivek, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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