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Monoclonal Gammopathy of Undetermined SignificanceGENOMGUSNCT01079429

Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.

An observational study of Monoclonal Gammopathy of Undetermined Significance and Smoldering Myeloma, run by Rennes University Hospital at 27 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Genetic study of DNA copies
How many people
1,200 participants
Where
27 sitesFrance
Study dates
12 Jan 2009to Sep 2019
Phase
Observational
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Monoclonal gammopathy of undetermined significance or Smoldering myeloma

Who may be able to join

  • Patients aged from 18 to 70 years
  • Written informed consent
  • One of the following three criteria:
  • Recently diagnosed IgG or IgA monoclonal gammopathy without clinical or biological features of malignant hemopathy
  • IgG or IgA MGUS regardless the date of the diagnosis
  • SMM regardless the date of the diagnosis
Show all 29Show fewer
  • Normal blood count, creatininemia and calcemia *
  • Bence-Jones proteinuria below 1g/24 hours
  • Absence of bone pain
  • No clinical or biological features of amyloidosis
  • No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) * In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)
  • Diagnostic criteria for MGUS:
  • Monoclonal component concentration below 30 g / l AND
  • Bone marrow plasmacytosis below 10%
  • Bence-Jones proteinuria below 1g/24 hours
  • Normal blood count, creatininemia and calcemia *
  • Absence of bone lesions on conventional bone radiographies
  • No clinical or biological features of amyloidosis
  • Absence of hyperviscosity syndrome
  • No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) * In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)
  • Diagnostic criteria for SMM:
  • Monoclonal component concentration greater than 30 g / l AND / OR
  • Bone marrow plasmacytosis greater than 10%
  • Bence-Jones proteinuria below 1g/24 hours
  • Normal blood count, creatininemia and calcemia *
  • Absence of bone lesions on conventional bone radiographies
  • No clinical or biological features of amyloidosis
  • Absence of hyperviscosity syndrome
  • No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) * In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Who cannot join

  • Patients younger than 18 years
  • Patients older than 71 years
  • IgM monoclonal gammopathy (regardless of diagnosis)
  • Monoclonal gammopathy associated with hematologic malignancies (multiple myeloma, chronic lymphocytic leukemia, ...)
  • Patients with chronic liver disease, autoimmune or neoplastic disease for less than 5 years
  • Active viral hepatitis B or C
Show all 9Show fewer
  • HIV seropositive patient
  • Pregnant woman
  • Breastfeeding woman

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

France27 sites

  • CHU Amiens - médecine interne

    Amiens

  • CHU Angers

    Angers

  • Centre Hospitalier H.Duffaut - Avignon

    Avignon

  • Hôpital Jean Minjoz - Besancon

    Besançon

  • Service de Médecine interne - Centre Hospitalier

    Blois, 41016

  • Bordeaux Bergonié

    Bordeaux

  • Bordeaux Haut Leveque

    Bordeaux

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux

  • Hôpital A.Morvan Brest

    Brest

  • Centre F.Baclesse

    Caen

  • CHU Caen

    Caen

  • Hôpital d'instruction des armées Percy

    Clamart

  • CHU Clermont Ferrand

    Clermont-Ferrand

  • CH Colmar

    Colmar

  • CH Dijon

    Dijon

  • CHG Dunkerque

    Dunkirk

  • CH Grenoble

    Grenoble

  • CH La Roche sur yon

    La Roche-sur-Yon

  • CH Laval

    Laval

  • Le Mans Victor Hugo

    Le Mans

  • Hôpital Claude Huriez

    Lille

  • Nantes University Hospital

    Nantes, Pays de Loire, 44000

  • Rennes University Hospital

    Rennes, Brittany Region, 35000

  • Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie

    Saint-Brieuc

  • CHU Toulouse Purpan

    Toulouse

  • CHU Toulouse Rangueil

    Toulouse

  • Service d'Hématologie - Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Large Scale Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From Monoclonal Gammopathy of Undetermined Significance (MGUS) and Indolent Myeloma (SMM).

The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.

Being tested
Genetic study of DNA copies
Keywords
Monoclonal gammopathy of undetermined significance, MGUS, Smoldering myeloma, SMM, Multiple myeloma
Medical subject headings
Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic study of DNA copiesGenetic

    Gene expression profiling, DNA copy number variation

Study groups in NCT01079429
Study groupRoleWhat they receive
MGUS or SMMPatients with Monoclonal gammopathy of undetermined significance or smoldering myeloma
Receives: Genetic: Genetic study of DNA copies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression to symptomatic multiple myeloma

    Measured: Every 6 or 12 months during 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2010 (estimated)
  2. Study start12 Jan 2009
  3. Primary completionJan 2014
  4. Study completionSep 2019

Why it stopped: sponsor and investigator 's decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01079429
Sponsor's protocol ID
RCB 2008-A01023-52
Other IDs
AFSSAPS B80894-60, IFM 08-02
Acronym
GENOMGUS
Status last verified
Apr 2021
First submitted
1 Mar 2010
Last updated
15 Apr 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Monoclonal Gammopathy of Undetermined Significance and Smoldering Myeloma, run by Rennes University Hospital at 27 sites 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 29 inclusion and 9 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: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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 was stopped early (reason given: sponsor and investigator 's decision). Results are not available in the source record.

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?

Progression to symptomatic multiple myeloma (time frame: Every 6 or 12 months during 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01079429.

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 15 Apr 2021.

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