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Smoldering Multiple Myeloma

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

Sponsored by Intergroupe Francophone du Myelome

About this trial

Last updated 3 years ago

Study ID

IFM 2017-04

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Age ≥ 18 years.

- SMM defined by IMWG 2014 criteria

1. 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%
2. 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.

No

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:

1. 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)
2. Renal insufficiency: creatinine clearance <40 mL/min or serum creatinine >177 μmol/L (>20 mg/L)
3. Anaemia: haemoglobin value of >2 g/dL below the lower limit of normal, or a haemoglobin value <10 g/dL
4. 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:

1. Clonal bone marrow plasmocytosis ≥60%
2. Involved/uninvolved serum Free Light Chain (FLC) ratio ≥ 100 (The involved free light chain must be ≥100 mg/L)
3. 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)

Locations

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