NCT01543100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

August 23, 2011

Last Update Submit

January 3, 2014

Conditions

Monoclonal GammopathyMonoclonal Gammopathy of Undetermined SignificationMyeloma

Keywords

MGUS

Outcome Measures

Primary Outcomes (3)

  • Blood levels of CEC and its progenitors

    Blood levels of CEC and its progenitors

    Day 1

  • Blood levels of soluble parameters of angiogenesis and of coagulability

    Blood levels of soluble parameters of angiogenesis and of coagulability

    Day 1

  • 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).

    Day 1

Secondary Outcomes (3)

  • Bone marrow levels of endothelial cells and its progenitors

    Day 1

  • Bone Marrow levels of soluble parameters of angiogenesis and of coagulability

    Day 1

  • Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).

    Day 1

Study Arms (1)

monoclonal gamopathy

EXPERIMENTAL

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.

Other: blood and bone marrow samples

Interventions

blood and bone marrow samplesOTHER

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.

monoclonal gamopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years old
  • No specific consent of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Conditions

ParaproteinemiasNeoplasms, Plasma Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Benoît GUILLET, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

March 2, 2012

Study Start

November 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

FR(1)