A Real-world Study in Participants With Smoldering Multiple Myeloma
NCT Number: NCT06472778
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Smoldering Multiple Myeloma
Sponsor: Janssen-Cilag Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-31
Completion Date: 2025-06-30
Locations: CHRU de Tours - Hopital Trousseau, Chambray Les Tours, 37170, France|Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source, Orleans, 45100, France|Hosp. Univ. Lucus Augusti, Lugo, 27003, Spain|Hosp. Clinico Univ. de Valladolid, Valladolid, 47003, Spain|Kent and Canterbury Hospital, Canterbury, CT1 3NG, United Kingdom|South Tees Hospitals NHS Foundation Trust, North Yorkshire, TS4 3BY, United Kingdom

Summary:
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.

Primary Outcome Measures: 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., Data collection up to 1 year and 2 months|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., Data collection up to 1 year and 2 months|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., Data collection up to 1 year and 2 months|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., Data collection up to 1 year and 2 months|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., 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., 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., 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., 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., 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., Data collection up to 1 year and 2 months
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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)., 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., 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., 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., 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., Data collection up to 1 year and 2 months