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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).


N/A
18 Years
70 Years
Open (Enrolling)
Both
Monoclonal Gammopathy of Undetermined Significance, Smoldering Myeloma

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Trial Information

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).


Inclusion Criteria:



- 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

- 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)

Exclusion Criteria:

- 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

- HIV seropositive patient

- Pregnant woman

- Breastfeeding woman

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression to symptomatic multiple myeloma

Outcome Time Frame:

Every 6 or 12 months during 5 years

Safety Issue:

No

Principal Investigator

Olivier DECAUX, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rennes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

RCB 2008-A01023-52

NCT ID:

NCT01079429

Start Date:

November 2010

Completion Date:

November 2018

Related Keywords:

  • Monoclonal Gammopathy of Undetermined Significance
  • Smoldering Myeloma
  • Monoclonal gammopathy of undetermined significance
  • MGUS
  • Smoldering myeloma
  • SMM
  • Multiple myeloma
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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