Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide
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|ClinicalTrials.gov Identifier: NCT00899080|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03|
|Actual Study Start Date :||July 4, 2008|
|Primary Completion Date :||August 4, 2008|
|Study Completion Date :||August 4, 2008|
U.S. FDA Resources
- Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels [ Time Frame: 1 month ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00899080
|Study Chair:||Suzanne Lentzsch, MD, PhD||University of Pittsburgh|