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.
Study Type
OBSERVATIONAL
Enrollment
431
Participant Characteristics and Treatment Patterns: Number of Participants With Type of Treatment
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.
Time frame: Data collection up to 1 year and 2 months
Participant Characteristics and Treatment Patterns: Duration of Treatment
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 frame: Data collection up to 1 year and 2 months
Participant Characteristics and Treatment Patterns: Time to Best Response
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.
Time frame: Data collection up to 1 year and 2 months
Participant Characteristics and Treatment Patterns: Overall Survival in Participants With SMM Overall and for High-risk and Non-high-risk Participants
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.
Time frame: Data collection up to 1 year and 2 months
Observation Patterns for High-risk and Non-high-risk SMM Participants and Overall
Observational patterns (example, frequency of visits and hospitalizations) will be reported for high-risk and non-high-risk SMM participants and overall.
Time frame: Data collection up to 1 year and 2 months
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CHRU de Tours - Hopital Trousseau
Chambray-lès-Tours, France
CHU Montpellier
Montpellier, France
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
Orléans, France
Hopital Pitie Salpetriere
Paris, France
CH Rene Dubos
Pontoise, France
Studienzentrum Gefos Dortmund mbH
Dortmund, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
ELBLANDKLINIKUM Riesa
Riesa, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
...and 19 more locations
Time to Progression to Multiple Myeloma (MM) in Participants With High-risk SMM
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.
Time frame: Data collection up to 1 year and 2 months
Progression-free Survival
Progression-free survival defined from the date of SMM diagnosis until date of MM diagnosis or death of any cause, whichever occurs first.
Time frame: Data collection up to 1 year and 2 months
Rates of Progression From SMM to MM for High and Non-high-risk Participants
Rate of progression from SMM to MM for high and non-high-risk participants will be evaluated as per SliM and/or CRAB criteria.
Time frame: Data collection up to 1 year and 2 months
Risk Factors of Progression From SMM to MM
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.
Time frame: Data collection up to 1 year and 2 months
Number of Participants With Myeloma-related Organ Damage Who Progress From SMM to MM
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.
Time frame: Data collection up to 1 year and 2 months
Percentage of Participants With High-risk and Non-high-risk SMM
Percentage of participants with high-risk and non-high-risk SMM will be reported.
Time frame: Baseline
Participant Characteristics With High-risk and Non-high-risk SMM
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.
Time frame: Data collection up to 1 year and 2 months
Best Response for the First-Line Treatment for MM
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 frame: Data collection up to 1 year and 2 months
Time to Best Response to MM Treatment
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.
Time frame: Data collection up to 1 year and 2 months
Number of Participants with Type of MM Treatment
Number of participants with type of MM treatment will be reported for participants whose SMM evolved to MM.
Time frame: Data collection up to 1 year and 2 months
Duration of MM Treatment
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.
Time frame: Data collection up to 1 year and 2 months
Overall Survival for Participants Whose SMM Evolved to MM
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.
Time frame: Data collection up to 1 year and 2 months
Disease Progression Related Deaths
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).
Time frame: Data collection up to 1 year and 2 months
Therapies Received
Type, dose, and start/end date of relevant therapies received since SMM diagnosis will be reported.
Time frame: Data collection up to 1 year and 2 months
Number of Participants With Adverse Drug Reactions (ADRs)
Number of participants with ADRs as recorded in participants' medical charts will be reported.
Time frame: Data collection up to 1 year and 2 months
Number of Participants With Abnormalities in Clinical Laboratory Tests
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.
Time frame: Data collection up to 1 year and 2 months
Survival Status at End of Study
Number of participants who were alive or dead at the end of the study will be reported.
Time frame: Data collection up to 1 year and 2 months