Smoldering Multiple MyelomaNCT06472778
A Real-world Study in Participants With Smoldering Multiple Myeloma
An observational study of Smoldering Multiple Myeloma, run by Janssen-Cilag Ltd. at 29 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Multiple Myeloma
- How many people
- 408 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 31 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants aged at least 18 years of age on the date of documented diagnosis of smoldering multiple myeloma (SMM) between 01 January 2016 and 31 December 2021.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
United Kingdom8 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Kent and Canterbury Hospital
Canterbury, CT1 3NG
University Hospital of Wales
Cardiff, CF14 4XW
University Hospitals Of Leicester Nhs Trust
Leicester, LE1 5WW
Barts Hospital
London, EC1 7ED
Manchester Royal Infirmary
Manchester, M13 9WL
South Tees Hospitals NHS Foundation Trust
North Yorks, TS4 3BY
Churchill Hospital
Oxford, OX3 7LE
Spain7 sites
Hosp Univ A Coruna
A Coruña, 15006
Hosp. Prov. de Avila
Ávila, 05004
Hosp. San Pedro de Alcantara
Cáceres, 10003
Hosp. Univ. Lucus Augusti
Lugo, 27003
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Hosp. Clinico Univ. de Valladolid
Valladolid, 47003
Hosp. Univ. de Alava
Vitoria-Gasteiz, 01005
France5 sites
CHRU de Tours - Hopital Trousseau
Chambray-lès-Tours, 37170
CHU Montpellier
Montpellier, 34295
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
Orléans, 45100
Hopital Pitie Salpetriere
Paris, 75013
CH Rene Dubos
Pontoise, 95303
Italy5 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale San Raffaele
Milan, 20132
Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
Roma, 00161
Policlinico Universitario Agostino Gemelli
Roma, 00168
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126
Germany4 sites
Studienzentrum Gefos Dortmund mbH
Dortmund, 44263
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
ELBLANDKLINIKUM Riesa
Riesa, 1589
Universitaetsklinikum Tuebingen
Tübingen, 72076
About this study
Official title: Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
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.
- Conditions
- Smoldering Multiple Myeloma
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Smoldering Multiple Myeloma (SMM) | Participants diagnosed with SMM between 01 January 2016 and 31 December 2021 will be enrolled in this study. Only data available outside of clinical studies from participant medical records will be collected. The data collected per participant in this study is defined as data available in medical charts from date of SMM diagnosis until 31 December 2023, death or lost to follow-up, whichever comes first. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data collection up to 1 year and 2 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data collection up to 1 year and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start31 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472778
- Sponsor's protocol ID
- 54767414SMM4001
- Other IDs
- 54767414SMM4001
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06472778
- Acronym / sponsor ID
- 54767414SMM4001
- Conditions
- Smoldering Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Smoldering Multiple Myeloma (SMM) | – | –Participants diagnosed with SMM between 01 January 2016 and 31 December 2021 will be enrolled in this study. Only data available outside of clinical studies from participant medical records will be collected. The data collected per participant in this study is defined as data available in medical charts from date of SMM diagnosis until 31 December 2023, death or lost to follow-up, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants aged at least 18 years of age on the date of documented diagnosis of smoldering multiple myeloma (SMM) between 01 January 2016 and 31 December 2021.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant Characteristics and Treatment Patterns: Number of Participants With Type of Treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
12 secondary outcomes
Percentage of Participants With High-risk and Non-high-risk SMM
Time frame: Baseline
Participant Characteristics With High-risk and Non-high-risk SMM
Time frame: Data collection up to 1 year and 2 months
Best Response for the First-Line Treatment for MM
Time frame: Data collection up to 1 year and 2 months
Time to Best Response to MM Treatment
Time frame: Data collection up to 1 year and 2 months
Number of Participants with Type of MM Treatment
Time frame: Data collection up to 1 year and 2 months
Duration of MM Treatment
Time frame: Data collection up to 1 year and 2 months
Overall Survival for Participants Whose SMM Evolved to MM
Time frame: Data collection up to 1 year and 2 months
Disease Progression Related Deaths
Time frame: Data collection up to 1 year and 2 months
Therapies Received
Time frame: Data collection up to 1 year and 2 months
Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: Data collection up to 1 year and 2 months
Number of Participants With Abnormalities in Clinical Laboratory Tests
Time frame: Data collection up to 1 year and 2 months
Survival Status at End of Study
Time frame: Data collection up to 1 year and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd Clinical Trial study director
Janssen-Cilag Ltd.
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoldering Multiple Myeloma, run by Janssen-Cilag Ltd. at 29 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, Spain, France, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Characteristics and Treatment Patterns: Number of Participants With Type of Treatment (time frame: Data collection up to 1 year and 2 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.