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CompletedNCT00899080Updated May 17, 2017

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

An observational study in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Eastern Cooperative Oncology Group. Completed. Open to participants aged Up to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Eastern Cooperative Oncology Group · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
33
Ages
Up to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma and Plasma Cell Neoplasm

Keywords

  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 33 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Samples submitted for research from patients enrolled on E4A03 or E1A00

Eligibility 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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
33 participants (actual)

Interventions

  • Geneticgene expression analysis
  • Geneticreverse transcriptase-polymerase chain reaction
  • Otherimmunoenzyme technique
  • Otherlaboratory biomarker analysis
  • Otherplatelet aggregation test
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00899080
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jul 4, 2008
Primary completion
Aug 4, 2008
Completion
Aug 4, 2008
Last update
May 17, 2017

Study contacts

Suzanne Lentzsch, MD, PhD
study chair · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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