Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm Thromboembolism |
Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis Other: medical chart review |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer. |
- Levels of circulating tissue factor (TF) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Alteration in coagulation parameters [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Correlation of TF with markers of coagulation activation and endothelial activation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Incidence of venous thromboembolism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
-
Other: enzyme-linked immunosorbent assay
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients diagnosed multiple Multiple Myeloma
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
Contacts and Locations| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683 | |
| Principal Investigator: | Nigel Mackman, PhD | UNC Lineberger Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01132833 History of Changes |
| Other Study ID Numbers: | LCCC 0802, P30CA016086, CDR0000674053 |
| Study First Received: | May 27, 2010 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
thromboembolism stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
Blood Protein Disorders Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Thromboembolism Thrombosis Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Embolism and Thrombosis Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013