SPARK
Research type
Research Study
Full title
Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
IRAS ID
338753
Contact name
Mamta Garg
Contact email
Sponsor organisation
Johnson and Johnson Innovative Medicine
Duration of Study in the UK
1 years, 1 months, 12 days
Research summary
This is a Real World multi-country, retrospective, non-interventional study to describe the Real World treatment outcomes of patients with Smoldering Multiple Myeloma and compare them according to different high-risk definitions.
Participants in this non-interventional study would have been diagnosed with SMM between 01 January 2016 and 31 December 2021. The study anticipates collecting data from at least 450 participants during a data collection period of approximately 12 months, at approximately 30 sites across 5 countries in Europe.This study primarily aims to descriptively compare three different criteria and stratification models used to identify high-risk patients - the AQUILA study criteria, the Mayo 20-2-20 and IMWG2020 (depending on cytogenetic availability)
The study also aims to characterize other clinical unmet needs of patients with SMM in a real-world (RW) setting which may be lead to potential benefits from future treatments.
REC name
London - Stanmore Research Ethics Committee
REC reference
24/PR/0362
Date of REC Opinion
28 May 2024
REC opinion
Further Information Favourable Opinion