A Real-world Study in Participants With Smoldering Multiple Myeloma

Last updated: April 25, 2025
Sponsor: Janssen-Cilag Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Cancer

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: 450
Study Start date:
January 14, 2024
Estimated Completion Date:
October 30, 2025

Connect with a study center

  • CHRU de Tours - Hopital Trousseau

    Chambray Les Tours, 37170
    France

    Active - Recruiting

  • CHU Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

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

    Orleans, 45100
    France

    Active - Recruiting

  • Hopital Pitie Salpetriere

    Paris Cedex 13, 75013
    France

    Active - Recruiting

  • CH Rene Dubos

    Pontoise cedex, 95303
    France

    Active - Recruiting

  • Klinikum Dortmund Klinikzentrum Mitte

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • ELBLANDKLINIKUM Riesa

    Riesa, 1589
    Germany

    Active - Recruiting

  • Universitaetsklinikum Tuebingen

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50134
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

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

    Roma, 00161
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

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

    Torino, 10126
    Italy

    Active - Recruiting

  • Hosp Univ A Coruna

    A Coruna, 15006
    Spain

    Active - Recruiting

  • Hosp. Prov. de Avila

    Avila, 05004
    Spain

    Active - Recruiting

  • Hosp. San Pedro de Alcantara

    Caceres, 10003
    Spain

    Active - Recruiting

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hosp. Univ. de Alava

    Vitoria, 01005
    Spain

    Active - Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • University Hospitals Of Leicester Nhs Trust

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • Barts Hospital

    London, EC1 7ED
    United Kingdom

    Active - Recruiting

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • South Tees Hospitals NHS Foundation Trust

    North Yorkshire, TS4 3BY
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

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