Clinical trial NCT01132833: Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
Official title: Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Plasma Cell Neoplasm
Thromboembolism
Keywords: thromboembolism
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed multiple Multiple Myeloma

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.

Detailed description: OBJECTIVES:

Primary

* To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.

Secondary

* To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin \[TAT\] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.
* To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.

OUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information.

After completion of study, patients are followed up for 3 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed; relapsed, or refractory multiple myeloma

PATIENT CHARACTERISTICS:

* Central venous access devices allowed
* Recruited by the Division of Hematology/Oncology and the Lineberger Comprehensive Cancer Center at the University of North Carolina
* No history of venous thromboembolism
* No hospitalization for \> 2 days within the past month
* Not pregnant
* No patient who refuses or is deemed unsuitable for chemotherapy

PRIOR CONCURRENT THERAPY:

* No surgery within the past month

  * Bone marrow biopsies, central venous line placement and diagnostic biopsies by surgery or fine-needle aspiration allowed
* \* No concurrent anticoagulation therapy

  * Concurrent antiplatelet agents, such as aspirin and/or clopidogrel, allowed

Primary outcomes:
measure: Levels of circulating tissue factor (TF)
timeFrame: 5 years
Secondary outcomes:
measure: Alteration in coagulation parameters
timeFrame: 5 years
measure: Correlation of TF with markers of coagulation activation and endothelial activation
timeFrame: 5 years
measure: Incidence of venous thromboembolism
timeFrame: 5 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Nigel Mackman, PhD
role: PRINCIPAL_INVESTIGATOR
References: