NCT06472778Completed
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 408 (actual)
- First submitted
- 19 Jun 2024
- Start date
- 31 May 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Janssen-Cilag Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT06472778
What you commit to
- Study type: Observational
- Participants enrolled: 408
- From 31 May 2024 to the primary completion date, 31 Dec 2025
- 29 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Therapy for multiple myeloma (MM) initiated within 90 days of SMM diagnosis
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Studienzentrum Gefos Dortmund mbH Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Universitaetsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Elblandklinikum Riesa Coordinator of this site? Confirm its status | Riesa | Germany | Unknown status |
| Universitaetsklinikum Tuebingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Hosp Univ A Coruna Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hosp. Prov. de Avila Coordinator of this site? Confirm its status | Ávila | Spain | Unknown status |
| Hosp. San Pedro de Alcantara Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Hosp. Univ. Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hosp. Clinico Univ. de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hosp. Univ. de Alava Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
| CHRU de Tours - Hôpital Trousseau Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Unknown status |
| CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CH René Dubos Coordinator of this site? Confirm its status | Pontoise | France | Unknown status |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Kent and Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Barts Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| South Tees Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | North Yorks | United Kingdom | Unknown status |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.