A Real-world Study in Participants With Smoldering Multiple Myeloma

Last updated: March 24, 2026
Sponsor: Janssen-Cilag Ltd.
Overall Status: Completed

Phase

N/A

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Bone Neoplasm

Treatment

N/A

Clinical Study ID

NCT06472778
54767414SMM4001
54767414SMM4001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the real-world characteristics and outcomes of participants with smoldering multiple myeloma (SMM) overall and by high-risk and non-high-risk SMM according to (AQUILA study criteria [NCT03301220], Mayo 20-2-20 and international myeloma working group (IMWG) 2020 risk classification models), and to evaluate the risk of progressing of SMM to multiple myeloma (MM) and outcomes in participants after progressing to MM.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a documented diagnosis of smoldering multiple myeloma (SMM). SMM is defined as: (a) Clonal bone marrow plasma cells (BMPCs) greater than or equal to (>=) 10 percent (%) and/or serum M-protein >= 3 grams per deciliter (g/dL) and/or urine M-protein >= 500 milligram per 24 hours (mg/24hrs). (b) Absence of SLiM-CRAB criteria: >= 60 %clonal BMPCs, involved/uninvolved free light chain (FLC) ratio >= 100 and involvedFLC >= 10 and magnetic resonance imaging (MRI) lesions; calcium elevation, renalinsufficiency, anemia, and bone lesions (AB) criteria

  • Informed consent obtained prior to retrospective data collection in accordance withlocal requirements, either an informed consent form (ICF) indicating that theparticipants signed a consent for data collection for this research and agrees tohave their data collected and analyzed, with source data verification (SDV), or thecountry does accept the ICF waiver for such type of studies

  • Data recorded in participants' medical charts from date of SMM diagnosis and atleast 2 years after should be available in the participant's medical chart at theparticipating site. However, participants who died within the 2 years from SMMdiagnosis are eligible

Exclusion

Exclusion Criteria:

  • Therapy for multiple myeloma (MM) initiated within 90 days of SMM diagnosis

  • Date of SMM diagnosis is missing

  • Participants who have participated/are participating in any SMM interventional (either active treatment or control arm) study are not eligible. Participation inobservational studies is allowed. Participants who have participated/areparticipating in any MM study after evolution to MM are eligible

Study Design

Total Participants: 431
Study Start date:
May 31, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHRU de Tours - Hopital Trousseau

    Chambray Les Tours, 37170
    France

    Site Not Available

  • CHRU de Tours - Hopital Trousseau

    Chambray-lès-Tours, 37170
    France

    Site Not Available

  • CHRU de Tours - Hopital Trousseau

    Chambray-lès-Tours 3027343, 37170
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • CHU Montpellier

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

    Orleans, 45100
    France

    Site Not Available

  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

    Orléans, 45100
    France

    Site Not Available

  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

    Orléans 2989317, 45100
    France

    Site Not Available

  • Hopital Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Hopital Pitie Salpetriere

    Paris 2988507, 75013
    France

    Site Not Available

  • Hopital Pitie Salpetriere

    Paris Cedex 13, 75013
    France

    Site Not Available

  • CH Rene Dubos

    Pontoise, 95303
    France

    Site Not Available

  • CH Rene Dubos

    Pontoise 2986140, 95303
    France

    Site Not Available

  • CH Rene Dubos

    Pontoise cedex, 95303
    France

    Site Not Available

  • Klinikum Dortmund Klinikzentrum Mitte

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Studienzentrum Gefos Dortmund mbH

    Dortmund, 44263
    Germany

    Site Not Available

  • Studienzentrum Gefos Dortmund mbH

    Dortmund 2935517, 44263
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • ELBLANDKLINIKUM Riesa

    Riesa, 1589
    Germany

    Site Not Available

  • ELBLANDKLINIKUM Riesa

    Riesa 2846939, 1589
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence 3176959, 50134
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan 6951411, 20132
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza

    Roma, 00161
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza

    Roma 8957247, 00161
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Hosp Univ A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp Univ A Coruna

    A Coruña, 15006
    Spain

    Site Not Available

  • Hosp Univ A Coruna

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Hosp. Prov. de Avila

    Avila, 05004
    Spain

    Site Not Available

  • Hosp. San Pedro de Alcantara

    Caceres, 10003
    Spain

    Site Not Available

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003
    Spain

    Site Not Available

  • Hosp. San Pedro de Alcantara

    Cáceres 2520611, 10003
    Spain

    Site Not Available

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003
    Spain

    Site Not Available

  • Hosp. Univ. Lucus Augusti

    Lugo 3117814, 27003
    Spain

    Site Not Available

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp Clinico Univ de Salamanca

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Valladolid

    Valladolid 3106672, 47003
    Spain

    Site Not Available

  • Hosp. Univ. de Alava

    Vitoria, 01005
    Spain

    Site Not Available

  • Hosp. Univ. de Alava

    Vitoria-Gasteiz, 01005
    Spain

    Site Not Available

  • Hosp. Univ. de Alava

    Vitoria-Gasteiz 3104499, 01005
    Spain

    Site Not Available

  • Hosp. Prov. de Avila

    Ávila, 05004
    Spain

    Site Not Available

  • Hosp. Prov. de Avila

    Ávila 3129136, 05004
    Spain

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham 2655603, B9 5SS
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury 2653877, CT1 3NG
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff 2653822, CF14 4XW
    United Kingdom

    Site Not Available

  • University Hospitals Of Leicester Nhs Trust

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • University Hospitals Of Leicester Nhs Trust

    Leicester 2644668, LE1 5WW
    United Kingdom

    Site Not Available

  • Barts Hospital

    London, EC1 7ED
    United Kingdom

    Site Not Available

  • Barts Hospital

    London 2643743, EC1 7ED
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester 2643123, M13 9WL
    United Kingdom

    Site Not Available

  • South Tees Hospitals NHS Foundation Trust

    North Yorks, TS4 3BY
    United Kingdom

    Site Not Available

  • South Tees Hospitals NHS Foundation Trust

    North Yorks 6940582, TS4 3BY
    United Kingdom

    Site Not Available

  • South Tees Hospitals NHS Foundation Trust

    North Yorkshire, TS4 3BY
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford 2640729, OX3 7LE
    United Kingdom

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.