Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.

  • STATUS
    Recruiting
  • End date
    Nov 5, 2027
  • participants needed
    450
  • sponsor
    Intergroupe Francophone du Myelome
Updated on 5 August 2020
Investigator
Hacène ZERAZHI, MD
Primary Contact
Centre Hospitalier H. Duffaut (67.9 mi away) Contact
+4 other location
multiple myeloma
monoclonal antibodies
monoclonal protein
amyloidosis
bone marrow plasma cells

Summary

This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

Description

In 2014, the International Myeloma Working Group (IMWG) proposed a revised classification of multiple myeloma (MM) and smoldering myeloma (SMM). Since the new definition of SMM proposed excludes "ultra-high risk SMM", the evolution profile of SMM will change. Therefore, investigators need to update their knowledge of SMM to optimize the management of patients. This project is expected to describe more precisely the new landscape of SMM.

The results will help to establish new recommendations for the standard care of SMM and especially for defining accurate follow-up and risk stratifying.

Details
Treatment Myelogram
Clinical Study IdentifierNCT04144387
SponsorIntergroupe Francophone du Myelome
Last Modified on5 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Smoldering Multiple Myeloma or Precancerous condition or Precancerous Conditions?
Age 18 years
SMM defined by IMWG 2014 criteria
Serum monoclonal protein (IgG or IgA) 30 g/L and/or urinary monoclonal protein 500 mg per 24 h and/or clonal bone marrow plasma cells 10-60%
Absence of myeloma defining events or amyloidosis
Diagnosed less than 1 year before the inclusion
Able and willing to give valid written informed consent. Patients must give written informed consent (IC) in accordance with institutional and local guidelines

Exclusion Criteria

Previous antimyeloma treatment including bisphosphonates
Second Primary Malignancy and/or auto-immune disease treated by immunosuppressive drugs
Evidence of end organ damage that can be attributed to the underlying SMM
Hypercalcaemia: serum calcium >0.25 mmol/L (>10 mg/L) higher than the upper limit of normal or >2.75 mmol/L (>110 mg/L)
Renal insufficiency: creatinine clearance <40 mL/min or serum creatinine >177 mol/L (>20 mg/L)
Anaemia: haemoglobin value of >2 g/dL below the lower limit of normal, or a haemoglobin value <10 g/dL
Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or Positron Emission Tomography-Computed Tomography (PET-CT)
Presence of one of the following biomarkers of malignancy
Clonal bone marrow plasmocytosis 60%
Involved/uninvolved serum Free Light Chain (FLC) ratio 100 (The involved free light chain must be 100 mg/L)
Presence of one or more focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
History of malignancy other than SMM within 3 years before inclusion
Amyloidosis
POEMS syndrome
Contraindication to MRI
Pregnancy
Nursing mother
Legally protected adults (under judicial protection, guardianship, or supervision)
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