Smoldering Multiple Myeloma
Conditions
Brief 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.
Interventions
None listed
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Characteristics and Treatment Patterns: Number of Participants With Type of Treatment | Data collection up to 1 year and 2 months | 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. |
| Participant Characteristics and Treatment Patterns: Duration of Treatment | Data collection up to 1 year and 2 months | 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. |
| Participant Characteristics and Treatment Patterns: Time to Best Response | Data collection up to 1 year and 2 months | 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. |
| Participant Characteristics and Treatment Patterns: Overall Survival in Participants With SMM Overall and for High-risk and Non-high-risk Participants | Data collection up to 1 year and 2 months | 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. |
| Observation Patterns for High-risk and Non-high-risk SMM Participants and Overall | Data collection up to 1 year and 2 months | 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) in Participants With High-risk SMM | Data collection up to 1 year and 2 months | 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 | Data collection up to 1 year and 2 months | Progression-free survival defined from the date of SMM diagnosis until date of MM diagnosis or death of any cause, whichever occurs first. |
| Rates of Progression From SMM to MM for High and Non-high-risk Participants | Data collection up to 1 year and 2 months | Rate of progression from SMM to MM for high and non-high-risk participants will be evaluated as per SliM and/or CRAB criteria. |
| Risk Factors of Progression From SMM to MM | Data collection up to 1 year and 2 months | 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 Myeloma-related Organ Damage Who Progress From SMM to MM | Data collection up to 1 year and 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With High-risk and Non-high-risk SMM | Baseline | Percentage of participants with high-risk and non-high-risk SMM will be reported. |
| Participant Characteristics With High-risk and Non-high-risk SMM | Data collection up to 1 year and 2 months | 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 for the First-Line Treatment for MM | Data collection up to 1 year and 2 months | 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 | Data collection up to 1 year and 2 months | 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 | Data collection up to 1 year and 2 months | Number of participants with type of MM treatment will be reported for participants whose SMM evolved to MM. |
| Duration of MM Treatment | Data collection up to 1 year and 2 months | 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 for Participants Whose SMM Evolved to MM | Data collection up to 1 year and 2 months | 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 | Data collection up to 1 year and 2 months | 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). |
| Therapies Received | Data collection up to 1 year and 2 months | Type, dose, and start/end date of relevant therapies received since SMM diagnosis will be reported. |
| Number of Participants With Adverse Drug Reactions (ADRs) | Data collection up to 1 year and 2 months | Number of participants with ADRs as recorded in participants' medical charts will be reported. |
| Number of Participants With Abnormalities in Clinical Laboratory Tests | Data collection up to 1 year and 2 months | 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. |
| Survival Status at End of Study | Data collection up to 1 year and 2 months | Number of participants who were alive or dead at the end of the study will be reported. |
Countries
France, Germany, Italy, Spain, United Kingdom
Contacts
STUDY_DIRECTORJanssen-Cilag Ltd Clinical Trial
Janssen-Cilag Ltd.
Outcome results
None listed