A Real-world Study in Participants With Smoldering Multiple Myeloma

Janssen (J&J Innovative Medicine)

Status: Enrolling

Conditions: Smoldering Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT06472778

54767414SMM4001

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Exclusion criteria

• Therapy for multiple myeloma (MM) initiated within 90 days of SMM diagnosis
• Date of SMM diagnosis is missing
• Have an MM-defining event at the stage of SMM diagnosis
• Participants who received an investigational treatment for SMM are not eligible. However, participants that received an investigational treatment only after evolution to MM (not during SMM observational period) are eligible

Trial design

450 participants in 1 patient group

Participants with Smoldering Multiple Myeloma (SMM)

Description:

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.