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New study maps the path from smoldering to active myeloma

NCT ID NCT06472778

Knowledge-focused Sponsor: Janssen-Cilag Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study reviewed medical records of 431 people with smoldering multiple myeloma (SMM), a pre-cancerous condition, to see how the disease progresses over time. Researchers looked at which patients are at higher risk of developing active multiple myeloma and what treatments they received. The goal is to better predict and manage the transition from smoldering to active disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

408 people

The number who actually took part.

Started

May 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Smoldering Multiple Myeloma smoldering plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoldering multiple myeloma

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

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

    Roma, 00161, Italy

  • Barts Hospital

    London, EC1 7ED, United Kingdom

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • CH Rene Dubos

    Pontoise, 95303, France

  • CHRU de Tours - Hopital Trousseau

    Chambray-lès-Tours, 37170, France

  • CHU Montpellier

    Montpellier, 34295, France

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

    Orléans, 45100, France

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • ELBLANDKLINIKUM Riesa

    Riesa, 1589, Germany

  • Hopital Pitie Salpetriere

    Paris, 75013, France

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003, Spain

  • Hosp. Prov. de Avila

    Ávila, 05004, Spain

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003, Spain

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003, Spain

  • Hosp. Univ. de Alava

    Vitoria-Gasteiz, 01005, Spain

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG, United Kingdom

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • South Tees Hospitals NHS Foundation Trust

    North Yorks, TS4 3BY, United Kingdom

  • Studienzentrum Gefos Dortmund mbH

    Dortmund, 44263, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University Hospitals Of Leicester Nhs Trust

    Leicester, LE1 5WW, United Kingdom

More trials for these conditions

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