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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899080
• Other study ID #: CDR0000600320
• Secondary ID: ECOG-E4A03T2
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 16, 2017
• Start date: July 4, 2008
• Est. completion date: August 4, 2008

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 4, 2008
• Est. primary completion date: August 4, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Genetic:
• gene expression analysis

• reverse transcriptase-polymerase chain reaction

Other:
• immunoenzyme technique

• laboratory biomarker analysis

• platelet aggregation test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels		1 month
Secondary	Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE)		1 month
Secondary	Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment		1 month
Secondary	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