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

  • End date
    Nov 5, 2027
  • participants needed
  • sponsor
    Intergroupe Francophone du Myelome
Updated on 5 August 2020
multiple myeloma
monoclonal antibodies
monoclonal protein
bone marrow plasma cells


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.


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.

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

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.


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
POEMS syndrome
Contraindication to MRI
Nursing mother
Legally protected adults (under judicial protection, guardianship, or supervision)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet