Sign in

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.
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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Studienzentrum Gefos Dortmund mbH
Coordinator of this site? Confirm its status
DortmundGermanyUnknown status
Universitaetsklinikum Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Elblandklinikum Riesa
Coordinator of this site? Confirm its status
RiesaGermanyUnknown status
Universitaetsklinikum Tuebingen
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status
Hosp Univ A Coruna
Coordinator of this site? Confirm its status
A CoruñaSpainUnknown status
Hosp. Prov. de Avila
Coordinator of this site? Confirm its status
ÁvilaSpainUnknown status
Hosp. San Pedro de Alcantara
Coordinator of this site? Confirm its status
CáceresSpainUnknown status
Hosp. Univ. Lucus Augusti
Coordinator of this site? Confirm its status
LugoSpainUnknown status
Hosp Clinico Univ de Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainUnknown status
Hosp. Clinico Univ. de Valladolid
Coordinator of this site? Confirm its status
ValladolidSpainUnknown status
Hosp. Univ. de Alava
Coordinator of this site? Confirm its status
Vitoria-GasteizSpainUnknown status
CHRU de Tours - Hôpital Trousseau
Coordinator of this site? Confirm its status
Chambray-lès-ToursFranceUnknown status
CHU Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
Coordinator of this site? Confirm its status
OrléansFranceUnknown status
Hopital Pitie-Salpetriere
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CH René Dubos
Coordinator of this site? Confirm its status
PontoiseFranceUnknown status
Birmingham Heartlands Hospital
Coordinator of this site? Confirm its status
BirminghamUnited KingdomUnknown status
Kent and Canterbury Hospital
Coordinator of this site? Confirm its status
CanterburyUnited KingdomUnknown status
University Hospital of Wales
Coordinator of this site? Confirm its status
CardiffUnited KingdomUnknown status
University Hospitals of Leicester NHS Trust
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
Barts Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Manchester Royal Infirmary
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
South Tees Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
North YorksUnited KingdomUnknown status
Churchill Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
Azienda Ospedaliera Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Policlinico Universitario Agostino Gemelli
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Coordinator of this site? Confirm its status
TorinoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.