Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899080
First received: May 9, 2009
Last updated: September 3, 2009
Last verified: October 2008

May 9, 2009
September 3, 2009
August 2008
September 2008   (final data collection date for primary outcome measure)
Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00899080 on ClinicalTrials.gov Archive Site
  • Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) [ Designated as safety issue: No ]
  • Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment [ Designated as safety issue: No ]
  • Specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development [ Designated as safety issue: No ]
Same as current
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Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide
Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood samples from patients with multiple myeloma who were treated with thalidomide or lenalidomide.

OBJECTIVES:

Primary

  • To analyze the mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) in patients with multiple myeloma treated on clinical trial ECOG-E4A03 or E-E1A00.
  • To determine the intensity, dynamics, and specificity of cathepsin G (CG) upregulation in response to thalidomide and lenalidomide treatment.
  • To determine the specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development.

OUTLINE: Blood samples obtained before, during, and after treatment with thalidomide or lenalidomide from patients previously enrolled on clinical trial ECOG-E4A03 or E-E1A00 are analyzed to determine the total content of cathepsin G (CG) via ELISA; to determine mRNA levels of CG via RT-PCR; and for platelet aggregation studies. Blood samples are collected from healthy volunteers for platelet preparation.

Observational
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Multiple Myeloma and Plasma Cell Neoplasm
  • Genetic: gene expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: immunoenzyme technique
  • Other: laboratory biomarker analysis
  • Other: platelet aggregation test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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September 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosed with multiple myeloma and treated with thalidomide or lenalidomide on clinical trial ECOG-E4A03 or E-E1A00
    • Healthy volunteer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
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Yes
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NCT00899080
CDR0000600320, ECOG-E4A03T2
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Suzanne Lentzsch, MD, PhD University of Pittsburgh
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP