A Real-world Study in Participants With Smoldering Multiple Myeloma

NCT06472778 | Completed

• 1 other identifier: 54767414SMM4001
• Study Type: observational
• Target: 431
• Locations: 5 countries
• Sites: 29

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.

Conditions

Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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 Outcomes (12)

• Percentage of Participants With High-risk and Non-high-risk SMM

  Baseline

• Participant Characteristics With High-risk and Non-high-risk SMM

  Data collection up to 1 year and 2 months

• Best Response for the First-Line Treatment for MM

  Data collection up to 1 year and 2 months

• Time to Best Response to MM Treatment

  Data collection up to 1 year and 2 months

• Number of Participants with Type of MM Treatment

  Data collection up to 1 year and 2 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (29)

CHRU de Tours - Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

Orléans, 45100, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

CH Rene Dubos

Pontoise, 95303, France

Location

Studienzentrum Gefos Dortmund mbH

Dortmund, 44263, Germany

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

ELBLANDKLINIKUM Riesa

Riesa, 1589, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza

Roma, 00161, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Prov. de Avila

Ávila, 05004, Spain

Location

Hosp. San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hosp. Univ. Lucus Augusti

Lugo, 27003, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Clinico Univ. de Valladolid

Valladolid, 47003, Spain

Location

Hosp. Univ. de Alava

Vitoria-Gasteiz, 01005, Spain

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

University Hospitals Of Leicester Nhs Trust

Leicester, LE1 5WW, United Kingdom

Location

Barts Hospital

London, EC1 7ED, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

North Yorks, TS4 3BY, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen-Cilag Ltd Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: May 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); DE (4); IT (5); ES (7); GB (8)