Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
Status: Recruiting
Location: See all (22) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 60 % plasma cells, 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 (SLiM-CRAB) 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 one year after should be available in the participant's medical chart at the participating site. However, data from any participants who died within the first year or after the first year after the SMM diagnosis is eligible
Locations
Other Locations
France
CHRU de Tours - Hopital Trousseau
RECRUITING
Chambray Les Tours
CHU Montpellier
RECRUITING
Montpellier
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
RECRUITING
Orleans
Hopital Pitie Salpetriere
RECRUITING
Paris Cedex 13
CH Rene Dubos
RECRUITING
Pontoise Cedex
Germany
Klinikum Dortmund Klinikzentrum Mitte
RECRUITING
Dortmund
Universitaetsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
Universitaetsklinikum Tuebingen
RECRUITING
Tuebingen
Italy
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Firenze
Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Spain
Hosp Univ A Coruna
RECRUITING
A Coruna
Hosp. Prov. de Avila
RECRUITING
Avila
Hosp. San Pedro de Alcantara
RECRUITING
Caceres
Hosp. Univ. Lucus Augusti
RECRUITING
Lugo
Hosp Clinico Univ de Salamanca
RECRUITING
Salamanca
Hosp. Clinico Univ. de Valladolid
RECRUITING
Valladolid
Hosp. Univ. de Alava
RECRUITING
Vitoria
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Kent and Canterbury Hospital
RECRUITING
Canterbury
University Hospitals Of Leicester Nhs Trust
RECRUITING
Leicester
South Tees Hospitals NHS Foundation Trust
RECRUITING
North Yorkshire
Churchill Hospital
RECRUITING
Oxford
Contact Information
Primary
Study Contact
Participate-In-This-Study@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-01-14
Estimated Completion Date:2025-10-30
Participants
Target number of participants:450
Treatments
Participants with Smoldering Multiple Myeloma (SMM)
Participants diagnosed with SMM between 01 January 2016 and 31 December 2021 will be enrolled in this study. Only data available outside of clinical studies from participant medical records will be collected. The data collected per participant in this study is defined as data in medical charts from date of SMM diagnosis until 31 December 2023, death or lost to follow-up, whichever comes first.