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Completed

NCT Number: NCT00899080

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

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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Key information

Conditions

Multiple Myeloma and Plasma Cell Neoplasm Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

reverse transcriptase-polymerase chain reaction

Genetic

immunoenzyme technique

Other

laboratory biomarker analysis

Other

platelet aggregation test

Other

Primary outcomes

  1. Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels

    Time frame: 1 month

Secondary outcomes

  1. Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE)

    Time frame: 1 month

  2. Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment

    Time frame: 1 month

  3. 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

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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