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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00899080
First received: May 9, 2009
Last updated: May 16, 2017
Last verified: May 2017
May 9, 2009
May 16, 2017
July 4, 2008
August 4, 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 [ Time Frame: 1 month ]
Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels
Complete list of historical versions of study NCT00899080 on ClinicalTrials.gov Archive Site
  • Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) [ Time Frame: 1 month ]
  • Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment [ Time Frame: 1 month ]
  • Specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development [ Time Frame: 1 month ]
  • Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE)
  • Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment
  • Specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development
Not Provided
Not Provided
 
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
Observational Model: Other
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Samples submitted for research from patients enrolled on E4A03 or E1A00
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
August 4, 2008
August 4, 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
Sexes Eligible for Study: All
up to 120 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00899080
CDR0000600320
ECOG-E4A03T2
Not Provided
Not Provided
Not Provided
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Suzanne Lentzsch, MD, PhD University of Pittsburgh
Eastern Cooperative Oncology Group
May 2017

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