A Real-world Study in Participants With Smoldering Multiple Myeloma

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.

Study Overview

• Status: Completed
• Conditions: Smoldering Multiple Myeloma

• Study Type: Observational
• Enrollment (Actual): 408

Contacts and Locations

Study Locations

• France
  • Chambray-lès-Tours, France, 37170
    • CHRU de Tours - Hôpital Trousseau
  • Montpellier, France, 34295
    • CHU Montpellier
  • Orléans, France, 45100
    • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
  • Paris, France, 75013
    • Hôpital Pitie Salpétrière
  • Pontoise, France, 95303
    • CH René Dubos
• Germany
  • Dortmund, Germany, 44263
    • Studienzentrum Gefos Dortmund mbH
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg Eppendorf
  • Riesa, Germany, 1589
    • Elblandklinikum Riesa
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
• Italy
  • Florence, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00161
    • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • Torino, Italy, 10126
    • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Cáceres, Spain, 10003
    • Hosp. San Pedro de Alcantara
  • Lugo, Spain, 27003
    • Hosp. Univ. Lucus Augusti
  • Salamanca, Spain, 37007
    • Hosp Clinico Univ de Salamanca
  • Valladolid, Spain, 47003
    • Hosp. Clinico Univ. de Valladolid
  • Vitoria-Gasteiz, Spain, 01005
    • Hosp. Univ. de Alava
  • Ávila, Spain, 05004
    • Hosp. Prov. de Avila
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Kent and Canterbury Hospital
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals of Leicester NHS Trust
  • London, United Kingdom, EC1 7ED
    • Barts Hospital
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary
  • North Yorks, United Kingdom, TS4 3BY
    • South Tees Hospitals NHS Foundation Trust
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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.	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.	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.	Data collection up to 1 year and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.	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.	Data collection up to 1 year and 2 months

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.
• Investigators: Study Director: Janssen-Cilag Ltd Clinical Trial, Janssen-Cilag Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Hematologic Diseases; Immunoproliferative Disorders; Precancerous Conditions; Paraproteinemias; Blood Protein Disorders; Hypergammaglobulinemia; Hemic and Lymphatic Diseases; Smoldering Multiple Myeloma
• Other Study ID Numbers: 54767414SMM4001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No