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Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy (PACMoG)

Primary Purpose

Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Signification, Myeloma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood and bone marrow samples
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Monoclonal Gammopathy focused on measuring MGUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

monoclonal gamopathy

Arm Description

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 yo, Patients having signed the specific consent of the study.

Outcomes

Primary Outcome Measures

Blood levels of CEC and its progenitors
Blood levels of CEC and its progenitors
Blood levels of soluble parameters of angiogenesis and of coagulability
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).
Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).

Secondary Outcome Measures

Bone marrow levels of endothelial cells and its progenitors
Bone marrow levels of endothelial cells and its progenitors
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
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).
Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).

Full Information

First Posted
August 23, 2011
Last Updated
January 3, 2014
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01543100
Brief Title
Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy
Acronym
PACMoG
Official Title
Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the literature to be associated with vascular failures and dysfunction that reflect neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy patients although they significantly increase in several cancers including myeloma. However, no study explored to date a correlation of CEC and/or circulating endothelial progenitors (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary multicentric study.
Detailed Description
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Signification, Myeloma
Keywords
MGUS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
monoclonal gamopathy
Arm Type
Experimental
Arm Description
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 yo, Patients having signed the specific consent of the study.
Intervention Type
Other
Intervention Name(s)
blood and bone marrow samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood levels of CEC and its progenitors
Description
Blood levels of CEC and its progenitors
Time Frame
Day 1
Title
Blood levels of soluble parameters of angiogenesis and of coagulability
Description
Blood levels of soluble parameters of angiogenesis and of coagulability
Time Frame
Day 1
Title
Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Description
Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Bone marrow levels of endothelial cells and its progenitors
Description
Bone marrow levels of endothelial cells and its progenitors
Time Frame
Day 1
Title
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
Description
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
Time Frame
Day 1
Title
Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).
Description
Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît GUILLET, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

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Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy

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