A Real-world Study in Participants With Smoldering Multiple Myeloma

Launched by JANSSEN-CILAG LTD. · Jun 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying people with a condition called smoldering multiple myeloma (SMM). SMM is a type of blood cancer that is not yet causing serious problems but could progress to a more severe form of the disease called multiple myeloma (MM). The researchers want to understand how SMM affects patients in the real world, focusing on different risk levels (high-risk vs. non-high-risk) and how often SMM progresses to MM. They will also look at the outcomes for patients who do progress to MM.

To be eligible for the study, participants need to have a confirmed diagnosis of SMM and meet specific health criteria, such as having a certain number of abnormal plasma cells in their bone marrow. Participants will need to provide consent for their medical data to be collected and analyzed, and their health information must be available for at least a year after their SMM diagnosis. This study is currently recruiting participants of all genders, aged 65 and older. If you or a loved one is interested in participating, you will be contributing valuable information that could help improve our understanding of this condition and its progression.

Gender

ALL

Eligibility criteria

• 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