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

NCT00899080 | Completed

• 2 other identifiers: CDR0000600320ECOG-E4A03T2
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (3)

• 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

Interventions

gene expression analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

platelet aggregation test OTHER

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples submitted for research from patients enrolled on E4A03 or E1A00

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Gene Expression Profiling; Reverse Transcriptase Polymerase Chain Reaction; Immunoenzyme Techniques; Platelet Aggregation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Activation; Hemostasis

Study Officials

• Suzanne Lentzsch, MD, PhD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: July 4, 2008
• Primary Completion: August 4, 2008
• Study Completion: August 4, 2008
• Last Updated: May 17, 2017

Record last verified: 2017-05