Clinical trial NCT06472778: A Real-world Study in Participants With Smoldering Multiple Myeloma
Official title: Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smoldering Multiple Myeloma
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Characteristics and Treatment Patterns: Number of Participants With Type of Treatment
timeFrame: Data collection up to 1 year and 2 months
measure: Participant Characteristics and Treatment Patterns: Duration of Treatment
timeFrame: Data collection up to 1 year and 2 months
measure: Participant Characteristics and Treatment Patterns: Time to Best Response
timeFrame: Data collection up to 1 year and 2 months
measure: Participant Characteristics and Treatment Patterns: Overall Survival in Participants With SMM Overall and for High-risk and Non-high-risk Participants
timeFrame: Data collection up to 1 year and 2 months
measure: Observation Patterns for High-risk and Non-high-risk SMM Participants and Overall
timeFrame: Data collection up to 1 year and 2 months
measure: Time to Progression to Multiple Myeloma (MM) in Participants With High-risk SMM
timeFrame: Data collection up to 1 year and 2 months
measure: Progression-free Survival
timeFrame: Data collection up to 1 year and 2 months
measure: Rates of Progression From SMM to MM for High and Non-high-risk Participants
timeFrame: Data collection up to 1 year and 2 months
measure: Risk Factors of Progression From SMM to MM
timeFrame: Data collection up to 1 year and 2 months
measure: Number of Participants With Myeloma-related Organ Damage Who Progress From SMM to MM
timeFrame: Data collection up to 1 year and 2 months
Secondary outcomes:
measure: Percentage of Participants With High-risk and Non-high-risk SMM
timeFrame: Baseline
measure: Participant Characteristics With High-risk and Non-high-risk SMM
timeFrame: Data collection up to 1 year and 2 months
measure: Best Response for the First-Line Treatment for MM
timeFrame: Data collection up to 1 year and 2 months
measure: Time to Best Response to MM Treatment
timeFrame: Data collection up to 1 year and 2 months
measure: Number of Participants with Type of MM Treatment
timeFrame: Data collection up to 1 year and 2 months
measure: Duration of MM Treatment
timeFrame: Data collection up to 1 year and 2 months
measure: Overall Survival for Participants Whose SMM Evolved to MM
timeFrame: Data collection up to 1 year and 2 months
measure: Disease Progression Related Deaths
timeFrame: Data collection up to 1 year and 2 months
measure: Therapies Received
timeFrame: Data collection up to 1 year and 2 months
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Data collection up to 1 year and 2 months
measure: Number of Participants With Abnormalities in Clinical Laboratory Tests
timeFrame: Data collection up to 1 year and 2 months
measure: Survival Status at End of Study
timeFrame: Data collection up to 1 year and 2 months
Other outcomes:
Locations:
city: Chambray Les Tours
country: France
facility: CHRU de Tours - Hopital Trousseau
city: Montpellier
country: France
facility: CHU Montpellier
city: Orleans
country: France
facility: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
city: Paris Cedex 13
country: France
facility: Hopital Pitie Salpetriere
city: Pontoise cedex
country: France
facility: CH Rene Dubos
city: Dortmund
country: Germany
facility: Studienzentrum Gefos Dortmund mbH
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Riesa
country: Germany
facility: ELBLANDKLINIKUM Riesa
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Avila
country: Spain
facility: Hosp. Prov. de Avila
city: Caceres
country: Spain
facility: Hosp. San Pedro de Alcantara
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Valladolid
country: Spain
facility: Hosp. Clinico Univ. de Valladolid
city: Vitoria
country: Spain
facility: Hosp. Univ. de Alava
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Leicester
country: United Kingdom
facility: University Hospitals Of Leicester Nhs Trust
city: London
country: United Kingdom
facility: Barts Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: North Yorkshire
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd Clinical Trial
role: STUDY_DIRECTOR
References: