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Smoldering Multiple MyelomaCARRISMMNCT04144387

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

A study testing Myelogram in people with Smoldering Multiple Myeloma, run by Intergroupe Francophone du Myelome at 90 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoldering Multiple Myeloma
What is being tested?
Myelogram
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
395 participants
Where
90 sitesin 3 countries
Study dates
11 Feb 2020to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 μmol/L (>20 mg/L)
  • Anaemia: haemoglobin value of >2 g/dL below the lower limit of normal, or a haemoglobin value <10 g/dL
Show all 18Show fewer
  • 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)

Trial locations and contacts

90 sites in 3 countries.

90 sites in 3 countries

France86 sites

  • Centre Hospitalier

    Abbeville

  • CHU Amiens Sud

    Amiens

  • CHRU - Hôpital du Bocage

    Angers

  • Ch Annecy Genevois

    Annecy

  • Centre Hospitalier d'Argenteuil Victor Dupouy

    Argenteuil

  • CH d'Arras

    Arras

  • Centre Hospitalier de Auch

    Auch

  • Centre Hospitalier H. Duffaut

    Avignon

  • Centre hospitalier de la Côte Basque

    Bayonne

  • Hôpital Nord Franche Comté

    Belfort

  • Centre Hospitalier Simone Veil

    Blois

  • Hôpital Avicenne

    Bobigny

  • Institut Bergonié - Pavillon Saint Genès - 1er étage

    Bordeaux

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux

  • Centre hospitalier Pierre Oudot

    Bourgoin

  • CHRU Brest - Hôpital A. Morvan

    Brest

  • CHU Caen - Côte de Nacre

    Caen

  • Centre Hospitalier

    Cannes

  • CH René Dubos

    Cergy-Pontoise

  • Médipôle de Savoie

    Challes-les-Eaux

  • Centre Hospitalier William Morey

    Chalon-sur-Saône

  • CH Chambéry

    Chambéry

  • Hôpital d'Instruction des Armées Percy

    Clamart

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • CHU Henri Mondor

    Créteil

  • Centre Hospitalier

    Dax

  • CHU François Mitterand

    Dijon

  • Centre Hospitalier de Dunkerque

    Dunkirk

  • Hôpital de Fréjus

    Fréjus

  • CHU de Grenoble

    Grenoble

  • Institut Daniel Hollard

    Grenoble

  • CHD Vendée

    La Roche-sur-Yon

  • Groupe Hospitalier de La Rochelle

    La Rochelle

  • Hospital Jacques Monod

    Le Havre

  • Centre Hospitalier

    Le Mans

  • Centre Hospitalier

    Lens

  • Centre hospitalier Robert Boulin

    Libourne

  • CHRU Hôpital Claude Huriez

    Lille

  • Centre Hospitalier Universitaire (CHU) de Limoges

    Limoges

  • Hôpital du Scorff

    Lorient

  • Centre Hospitalier Lyon Sud

    Lyon

  • Centre Léon Bérard

    Lyon

  • CH Meaux

    Meaux

  • Hospital Sainte Blandine

    Metz

  • Hôpital de Mercy (CHR Metz-Thionville)

    Metz

  • Centre de Recherche Clinique / GHT des Landes

    Mont-de-Marsan

  • Clinique du Parc

    Montpellier

  • Hopital Saint Eloi - CHU Montpellier

    Montpellier

  • Hôpital E. Muller

    Mulhouse

  • CHRU Hôpitaux de Brabois

    Nancy

  • Centre Catherine de Sienne

    Nantes

  • CHRU Hôtel Dieu

    Nantes

  • Hôpital Archet 1

    Nice

  • CHU Carémeau, Institut de Cancérologie du Guard

    Nîmes

  • CH La Source

    Orléans

  • CHU Hôpital Saint Antoine

    Paris

  • Hôpital Cochin

    Paris

  • Hôpital Necker

    Paris

  • Hôpital Saint Louis

    Paris

  • La Pitié

    Paris

  • Centre Hospitalier de Perigueux

    Périgueux

  • CH Saint Jean

    Perpignan

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie

    Pessac

  • CHU Poitiers - Pôle régional de Cancérologie

    Poitiers

  • Centre Hospitalier de Quimper Cornouaille

    Quimper

  • Hôpital Robert Debré

    Reims

  • CHRU Hôpital de Pontchaillou

    Rennes

  • Hôpital Privé Sévigné

    Rennes

  • Centre Hospitalier Jacques Puel

    Rodez

  • CH Roubaix

    Roubaix

  • Centre Henri Becquerel

    Rouen

  • Centre Hospitalier Yves Le Foll

    Saint-Brieuc

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest

  • Centre Hospitalier

    Saint-Quentin

  • CH Saint Malo

    St-Malo

  • CHU Strasbourg - Hôpital de Hautepierre

    Strasbourg

  • Strasbourg Oncologie Libérale

    Strasbourg

  • Centre hospitalier de Tarbes

    Tarbes

  • Hôpital Inter-Armées Ste Anne

    Toulon

  • Pôle IUCT Oncopole CHU

    Toulouse

  • CHRU Hôpital Bretonneau - Centre Henry Kaplan

    Tours

  • Centre Hospitalier de Troyes

    Troyes

  • Centre Hospitalier de Valence

    Valence

  • Centre Hospitalier

    Valenciennes

  • CH Bretagne Atlantique Vannes et Auray - P. Chubert

    Vannes

  • CHV André Mignot - Université de Versailles

    Versailles

Other trials in France

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Institut Jules Bordet

    Brussels

  • CHU UCL Namur ASBL Site Godinne

    Yvoir

Other trials in Belgium

Monaco1 site

  • Centre Hospitalier Princesse Grace

    Monaco

Other trials in Monaco

About this study

Official title: Evaluation of 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 (CARRISMM)

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.

Read the detailed 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.

Being tested
Myelogram
Medical subject headings
Smoldering Multiple Myeloma

What participants receive

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

  • MyelogramProcedure or surgery

    Two additional myelograms will be performed comparing to standard of care.

Study groups in NCT04144387
Study groupRoleWhat they receive
Test groupExperimentalEach patient included in the study will be followed for 5 years
Receives: Procedure: Myelogram

What is being measured

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

  1. Assess the annual risk estimated at 2 years of progression from SMM to MM

    Progression to MM will be defined, according to IMWG 2014 revised classification, by the apparition of one or more myeloma defining events:

    • Evidence of end organ damage that can be attributed to the underlying MM (CRAB criteria)
    • Presence of one of the following biomarkers of malignancy (new criteria of MM introduced in 2014 IMWG recommendations)

    Measured: 2 years

Secondary outcomes (4)

  1. Assess the risk of progression to MM evaluating biological factors

    • Progression of monoclonal component level (serum M component, urine M component or FLC involved/uninvolved) defined by increase of ≥ 25% from inclusion value.
    • Progression of percentage of phenotypically abnormal Bone Marrow Plasma Cells defined by increase of ≥ 10 % from inclusion value or an increase to over 95%

    Measured: 5 years

  2. Assess the risk of progression to MM evaluating radiological markers

    MRI progression : Progression of MRI abnormalities defined by any one or more of the following

    • Appearance of new focal lesion or new diffuse infiltration of previously unaffected regions
    • Growth of previously preexisting < 5mm focal(s) lesion(s)
    • Progressive diffuse infiltration of already affected bones

    Measured: 5 years

  3. Describe the clonal and sub-clonal evolution of SMM

    Genetic analysis of bone marrow plasma cells at inclusion and during follow up to give data about the clonal and subclonal evolution of SMM (analysis of the mutations present in the tumor plasma cells, the allele frequency of each mutations, the determination of the clonal evolution mode for patients who will evolve to overt MM, the evaluation of copy number changes enabling to detect all the prognostic changes (1p32, 1q, 17p13), and (v) all the 14q32 translocations).

    Measured: 5 years

  4. Describe annual risk of progression from SMM to MM at 5 years

    Measured: 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 posted30 Oct 2019
  2. Study start11 Feb 2020
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144387
Sponsor's protocol ID
IFM 2017-04
Other IDs
2016-002650-20, 2016
Acronym
CARRISMM
Status last verified
Mar 2024
First submitted
18 Oct 2019
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Myelogram in people with Smoldering Multiple Myeloma, run by Intergroupe Francophone du Myelome at 90 sites in 3 countries.

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 6 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in France, Belgium, Monaco. 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?

This study is still under way. Results are not available in the source record yet.

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?

Assess the annual risk estimated at 2 years of progression from SMM to MM (time frame: 2 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 NCT04144387.

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 6 Mar 2024.

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