Informations générales (source: ClinicalTrials.gov)
Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
Observational
Janssen-Cilag Ltd. (Voir sur ClinicalTrials)
janvier 2024
octobre 2025
29 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| HOPITAL NOVO | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source - 45100 - Orleans - France | Contact (sur clinicalTrials) | ||||
| CHRU de Tours - Hopital Trousseau - 37170 - Chambray Les Tours - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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