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My Saved Trials

A Real-world Study in Participants With Smoldering Multiple Myeloma

Last Updated   May 29, 2025

Want to learn how to participate in this trial?

54767414SMM4001

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
  • Sites
    29 Sites
  • Status
    Recruiting

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.

CONDITIONS

  • Smoldering Multiple Myeloma

ELIGIBILITY


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 involved FLC >= 10 and magnetic resonance imaging (MRI) lesions; calcium elevation, renal insufficiency, anemia, and bone lesions (AB) criteria
* Informed consent obtained prior to retrospective data collection in accordance with local requirements, either an informed consent form (ICF) indicating that the participants signed a consent for data collection for this research and agrees to have their data collected and analyzed, with source data verification (SDV), or the country does accept the ICF waiver for such type of studies
* Data recorded in participants' medical charts from date of SMM diagnosis and at least 2 years after should be available in the participant's medical chart at the participating site. However, participants who died within the 2 years from SMM diagnosis are eligible


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 in observational studies is allowed. Participants who have participated/are participating in any MM study after evolution to MM are eligible


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 mi

More...

DETAILS

LOCATIONS

Locations in:
France, Spain, Germany, Italy, United Kingdom
Country (5) City or Province (29) Status
France Orleans Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
RECRUITING
Spain Lugo Hosp. Univ. Lucus Augusti
RECRUITING
Spain Valladolid Hosp. Clinico Univ. de Valladolid
RECRUITING
France Chambray Les Tours CHRU de Tours - Hopital Trousseau
RECRUITING
France Montpellier CHU Montpellier
RECRUITING
France Paris Cedex 13 Hopital Pitie Salpetriere
RECRUITING
France Pontoise cedex CH Rene Dubos
RECRUITING
Germany Dortmund Klinikum Dortmund Klinikzentrum Mitte
RECRUITING
Germany Hamburg Universitaetsklinikum Hamburg Eppendorf
RECRUITING
Germany Tuebingen Universitaetsklinikum Tuebingen
RECRUITING
Italy Firenze Azienda Ospedaliera Universitaria Careggi
RECRUITING
Italy Milano Ospedale San Raffaele
RECRUITING
Italy Roma Policlinico Universitario Agostino Gemelli
RECRUITING
Spain A Coruna Hosp Univ A Coruna
RECRUITING
Spain Avila Hosp. Prov. de Avila
RECRUITING
Spain Caceres Hosp. San Pedro de Alcantara
RECRUITING
Spain Salamanca Hosp Clinico Univ de Salamanca
RECRUITING
Spain Vitoria Hosp. Univ. de Alava
RECRUITING
United Kingdom Birmingham Birmingham Heartlands Hospital
RECRUITING
United Kingdom Canterbury Kent and Canterbury Hospital
RECRUITING
United Kingdom Leicester University Hospitals Of Leicester Nhs Trust
RECRUITING
United Kingdom North Yorkshire South Tees Hospitals NHS Foundation Trust
RECRUITING
United Kingdom Oxford Churchill Hospital
RECRUITING
Germany Riesa ELBLANDKLINIKUM Riesa
RECRUITING
Italy Roma Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
RECRUITING
Italy Torino Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
RECRUITING
United Kingdom Cardiff University Hospital of Wales
RECRUITING
United Kingdom London Barts Hospital
RECRUITING
United Kingdom Manchester Manchester Royal Infirmary
RECRUITING
Show More
Geo Locations

47.90289, 1.90389

43.00992, -7.55602

41.65518, -4.72372

47.33537, 0.70286

43.61092, 3.87723

48.85341, 2.3488

49.05, 2.1

51.51494, 7.466

53.57532, 10.01534

48.52266, 9.05222

43.77925, 11.24626

45.46427, 9.18951

41.89193, 12.51133

43.37135, -8.396

40.65724, -4.69951

39.47649, -6.37224

40.96882, -5.66388

42.84998, -2.67268

52.48142, -1.89983

51.27904, 1.07992

52.6386, -1.13169

54.07369, -0.95032

51.75222, -1.25596

51.30777, 13.29168

41.89193, 12.51133

45.07049, 7.68682

51.48, -3.18

51.50853, -0.12574

53.48095, -2.23743

x
50

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10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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