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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
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Actual Study Start Date: July 4, 2008
Study Completion Date: August 4, 2008
Primary Completion Date: August 4, 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients enrolled on E4A03 or E1A00
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899080

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Suzanne Lentzsch, MD, PhD University of Pittsburgh
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00899080     History of Changes
Other Study ID Numbers: CDR0000600320
ECOG-E4A03T2
Study First Received: May 9, 2009
Last Updated: May 16, 2017

Keywords provided by Eastern Cooperative Oncology Group:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 21, 2017