Monoclonal GammopathyPACMoGNCT01543100
Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy
A study testing blood and bone marrow samples in people with Monoclonal Gammopathy and Monoclonal Gammopathy of Undetermined Signification, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Signification, Myeloma
- What is being tested?
- blood and bone marrow samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Treatment with chemotherapy and/or antiangiogenic drugs at the inclusion
- Age < 18 years old
- No specific consent of the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Being tested
- blood and bone marrow samples
- Keywords
- MGUS
- Medical subject headings
- Paraproteinemias, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: blood and bone marrow samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of CEC and its progenitors
Blood levels of CEC and its progenitors
Measured: Day 1
Blood levels of soluble parameters of angiogenesis and of coagulability
Blood levels of soluble parameters of angiogenesis and of coagulability
Measured: 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).
Measured: Day 1
Secondary outcomes (3)
Bone marrow levels of endothelial cells and its progenitors
Bone marrow levels of endothelial cells and its progenitors
Measured: Day 1
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
Measured: Day 1
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startNov 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal GammopathyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît GUILLET, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543100
- Sponsor's protocol ID
- LOC/10-02 - PACMoG
- Other IDs
- 2010-A00378-31, B100413-10, 10/16-758
- Acronym
- PACMoG
- Status last verified
- Jan 2014
- First submitted
- 23 Aug 2011
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy
- ClinicalTrials.gov ID
- NCT01543100
- Acronym / sponsor ID
- PACMoG / LOC/10-02 - PACMoG
- Keywords
- MGUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monoclonal gamopathy | Experimental | Other: blood and bone marrow samplesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Treatment with chemotherapy and/or antiangiogenic drugs at the inclusion
- Age < 18 years old
- No specific consent of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and bone marrow samplesSpecific 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. | Other | monoclonal gamopathy |
Primary outcome
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).
3 secondary outcomes
Bone marrow levels of endothelial cells and its progenitors
Time frame: Day 1
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
Time frame: Day 1
Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît GUILLET, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and bone marrow samples in people with Monoclonal Gammopathy and Monoclonal Gammopathy of Undetermined Signification, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels of CEC and its progenitors (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.