A Real-world Study in Participants With Smoldering Multiple Myeloma

Number of participants with type of treatment (example, autologous stem cell transplant [ASCT], chimeric antigen receptor [CAR-T], proteasome inhibitor [PI], and immunomodulatory drug [iMID]) will be reported in participants with smoldering multiple myeloma (SMM) overall and by high-risk and non-high-risk classifications.

Duration of treatment as defined from the date of first dose of SMM treatment until the last dose of SMM treatment by treatment type will be reported.

Time to best response is defined as the time interval from the date of first dose of SMM treatment until recorded best response, by treatment type. Time to best response for SMM treatments will not be collected for countries which do not allow it.

Overall survival is defined as the time interval from the date of SMM diagnosis until the date of last observation (that is, date of end of study for each participant) or death, whichever comes first.

Observational patterns (example, frequency of visits and hospitalizations) will be reported for high-risk and non-high-risk SMM participants and overall.

Time to progression to multiple myeloma (MM) is defined as the the time from the date of SMM diagnosis to the date of MM diagnosis, as defined by 60 percent plasma cells, light chains, and MRI lesions (SLiM) and/or calcium elevation, renal insufficiency, anemia, and bone lesions (CRAB) criteria.

Progression-free survival defined from the date of SMM diagnosis until date of MM diagnosis or death of any cause, whichever occurs first.

Rate of progression from SMM to MM for high and non-high-risk participants will be evaluated as per SliM and/or CRAB criteria.

Potential risk factors/predictors for progression from SMM diagnosis to MM will be investigated, for high-risk participants and non-high-risk participants according to AQUILA study criteria (NCT03301220), Mayo 20-2-20 and international myeloma working group (IMWG) 2020 risk stratification models, example age at SMM diagnosis and eastern cooperative oncology group (ECOG) at SMM diagnosis.

Number of participants with outcomes of myeloma-related organ damage who progress from SMM to MM will be summarized overall and by high-risk and non-high-risk participants.

Percentage of participants with high-risk and non-high-risk SMM will be reported.

Participant characteristics with high-risk and non-high risk SMM (example, age at SMM and MM diagnosis, date of SMM and MM diagnosis, Sex at birth, ECOG, and country) will be reported.

Best Response on first-line MM therapy (stringent complete response [sCR], complete response [CR], and partial response [PR]) will be reported based on the IMWG response criteria. Best response for SMM treatments will not be collected for countries which do not allow it.

Time to best response to MM treatment defined as the time interval from the date of first dose of MM treatment until recorded best response, by treatment type. Time to best response for SMM treatments will not be collected for countries which do not allow it.

Number of participants with type of MM treatment will be reported for participants whose SMM evolved to MM.

Duration of treatment defined from the date of first dose for MM until the last dose of MM treatment, by type of treatment will be reported.

Overall survival is defined as the time interval from the date of SMM diagnosis until the date of last observation (that is, date of end of study for each participant) or death, whichever comes first.

Disease progression related deaths will be reported. Disease progression related deaths defined as the time from the date of SMM diagnosis to the date of death due to disease progression (primary cause).

Type, dose, and start/end date of relevant therapies received since SMM diagnosis will be reported.

Number of participants with ADRs as recorded in participants' medical charts will be reported.

Number of participants with abnormalities in clinical laboratory tests (only available hematology, chemistry, and bone marrow biopsy or aspirate results that are obtained as part of the participants' usual standard of care) will be reported.

Number of participants who were alive or dead at the end of the study will be reported.