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

NCT00899080 — Completed, 33 participants, Eastern Cooperative Oncology Group
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Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03

RegistryNCT00899080
StatusCompleted
Study typeObservational
Enrollment33 (Actual)
SponsorEastern Cooperative Oncology Group (Network); collaborators: National Cancer Institute (NCI)
ConditionsMultiple Myeloma and Plasma Cell Neoplasm
Interventionsgene expression analysis, reverse transcriptase-polymerase chain reaction, immunoenzyme technique, laboratory biomarker analysis, platelet aggregation test (Genetic, other)
Datesstart 2008-07-04, primary completion 2008-08-04, completion 2008-08-04, first posted 2009-05-12, last updated 2017-05-17

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

  • gene expression analysis (Genetic)
  • reverse transcriptase-polymerase chain reaction (Genetic)
  • immunoenzyme technique (Other)
  • laboratory biomarker analysis (Other)
  • platelet aggregation test (Other)

+Outcome measures

Primary outcomes

  • Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels [1 month]

Secondary outcomes

  • Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) [1 month]
  • Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment [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 [1 month]

+Eligibility

Sex: All, ages: any to 120 Years, accepts healthy volunteers

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

+Investigators

My Notes