Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy (PACMoG)
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ClinicalTrials.gov Identifier: NCT01543100 |
Recruitment Status
:
Completed
First Posted
: March 2, 2012
Last Update Posted
: January 6, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Monoclonal Gammopathy Monoclonal Gammopathy of Undetermined Signification Myeloma | Other: blood and bone marrow samples | Not Applicable |
Principal objective : Research of a correlation of blood CEC and MPs with the tumoral volume and the clinico-biological staging of monoclonal gammopathies.
Secondary objectives : Research of a correlation of bone marrow endothelial cells and MPs, both measured by flow cytometry, with the tumoral volume and the clinico-biological staging of monoclonal gammopathies.
Principal analyses : Blood levels of CEC and its progenitors, soluble parameters of angiogenesis and of coagulability, and microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Secondary analyses : Bone marrow levels of endothelial cells and its progenitors, soluble parameters of angiogenesis and of coagulability, and microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Methodology : PACMoG is an interventional, prospective and multicentric pilot study. Biologic parameters will be determined at the diagnosis of monoclonal gammopathy. Results will be compared to the monoclonal gammopathy international staging and the clinical follow-up.
Procedures : Specific tests of the study will be realized from :
- Blood samples: 2 EDTA tubes and 1 tube without anticoagulant per included patient.
- Bone marrow: 3 ml collected during of myelogram punction made for the diagnosis.
In all cases, no additional sampling will be performed.
Specific analyses :
- Specific biological assays in blood and bone marrow will be:
- Endothelial and progenitor cells levels
- Number and cellular origin of MPSs
- Levels of phospholipid-dependant coagulability
- Soluble parameters of angiogenesis (VEGF, soluble CD146, endostatin)
- Soluble parameters of coagulability (Levels of thrombomodulin, tissue factor and D-Dimer)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: monoclonal gamopathy
Patients with monoclonal gammopathy either MGUS or myeloma at diagnosis or more than 3 months after a first myeloma treatment with chemotherapy and/or antiangiogenic drugs.
|
Other: blood and bone marrow samples
Specific tests of the study will be realized from :
In all cases, no additional sampling will be performed. |
- Blood levels of CEC and its progenitors [ Time Frame: Day 1 ]Blood levels of CEC and its progenitors
- Blood levels of soluble parameters of angiogenesis and of coagulability [ Time Frame: Day 1 ]Blood levels of soluble parameters of angiogenesis and of coagulability
- Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak). [ Time Frame: Day 1 ]Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
- Bone marrow levels of endothelial cells and its progenitors [ Time Frame: Day 1 ]Bone marrow levels of endothelial cells and its progenitors
- Bone Marrow levels of soluble parameters of angiogenesis and of coagulability [ Time Frame: Day 1 ]Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
- Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak). [ Time Frame: Day 1 ]Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with monoclonal gammopathy either MGUS or myeloma at diagnosis or more than 3 months after a first myeloma treatment with chemotherapy and/or antiangiogenic drugs.
- Patient's age ≥ 18 years old,
- Patients having signed the specific consent of the study.
Exclusion Criteria:
- Treatment with chemotherapy and/or antiangiogenic drugs at the inclusion
- Age < 18 years old
- No specific consent of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543100
France | |
Rennes University Hospital | |
Rennes, Bretagne, France, 35033 |
Principal Investigator: | Benoît GUILLET, MD | Rennes University Hospital |
Responsible Party: | Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT01543100 History of Changes |
Other Study ID Numbers: |
LOC/10-02 - PACMoG 2010-A00378-31 ( Other Identifier: ID RCB ) B100413-10 ( Other Identifier: AFSSAPS ) 10/16-758 ( Other Identifier: CPP Rennes ) |
First Posted: | March 2, 2012 Key Record Dates |
Last Update Posted: | January 6, 2014 |
Last Verified: | January 2014 |
Keywords provided by Rennes University Hospital:
MGUS |
Additional relevant MeSH terms:
Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Blood Protein Disorders Hematologic Diseases |
Immunoproliferative Disorders Immune System Diseases Hypergammaglobulinemia |