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Heart risks under the microscope: lenalidomide safety study in myeloma

NCT ID NCT03106324

Knowledge-focused Sponsor: Celgene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study followed over 900 newly diagnosed multiple myeloma patients who were not eligible for a stem cell transplant. Researchers compared heart-related side effects between those treated with lenalidomide (Revlimid) and those receiving other treatments. The goal was to better understand the safety of lenalidomide in this specific group of patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenalidomide (Revlimid)
What this could lead to
If successful, this study could help doctors understand the heart-related risks of lenalidomide in older myeloma patients, leading to safer treatment choices.
What could go wrong
This is an observational study, not a controlled trial, so it can show links but not prove cause and effect. Results may be influenced by other patient factors.

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

911 people

The number who actually took part.

Started

Mar 2017

Finished

Jan 2026

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

Patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant (TNE) starting their first treatment for multiple myeloma. Patients receiving any first line regimen can be included into the study. Decision for treatment needs to be done before inclusion into the trial.

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: 1. Must have understood and voluntarily signed the Informed Consent Form (ICF) 2. Age ≥ 18 years at the time of signing the ICF 3. Newly diagnosed with multiple myeloma 4. Must not be eligible for transplant 5. Will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles. Exclusion Criteria: 1. Prior treatment for Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line Multiple myeloma (MM) therapy. 2. Prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line MM therapy through clinical trial participation or patient access program 3. Two or more complete cycles of first-line therapy or any agent considered to be a firstline MM therapy for newly diagnosed multiple myeloma (NDMM) treatment before study enrollment 4. Refusal to participate in the Revlimid Transplant noneligible (TNE) Newly diagnosed multiple myeloma (NDMM) Post-authorization safety study (PASS) or current participation in the treatment phase of an interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche

    Cagliari, 0-9121, Italy

  • A.O Bianchi Melacrino Morelli - Presidio Riuniti

    Regio Calabria, 89125, Italy

  • AO Garibaldi Catania

    Catania, 95122, Italy

  • AO Garibaldi Catania - Via Palermo 636

    Catania, 95122, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -

    Milan, 20162, Italy

  • AZ Groeninge

    Kortijk, 8500, Belgium

  • AZ Nikolaas

    Sint Niklass, 9100, Belgium

  • Aalborg University Hospital

    Aalborg, 9100, Denmark

  • Academic Hospital Maastricht

    Maastricht, 3526 KV, Netherlands

  • Admiraal de Ruyter Hospital

    Goes, 4462 RA, Netherlands

  • Akershus universitetssykehus HF

    Lørenskog, 1478, Norway

  • Betsi Cadwaladr University Health Board - Glan Clwyd Hospital

    Bodelwyddan, LL18 5UJ, United Kingdom

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS,, United Kingdom

  • CH Mont de Marsan

    Mont-de-Marsan, 40000, France

  • CH St Jean

    Perpignan, 66093, France

  • CH Victor Dupouy

    Argenteuil, 95100, France

  • CH de Libourne

    Libourne, 33505, France

  • CHPLT Verviers

    Verviers, 4800, Belgium

  • CHR Citadelle Liège

    Liège, 4000, Belgium

  • CHR Orleans

    Orléans, 45100, France

  • CHU Ambroise Pare

    Mons, 7000, Belgium

  • CHU Saint-Pierre

    Brussels, 1000, Belgium

  • CHU de Nice

    Nice, O6200, France

  • CHU du Mont-Godinne

    Yvoir, 5530, Belgium

  • CHU-Charleroi

    Brussels, 6110, Belgium

  • CHU-Charleroi

    Charleroi, 6042, Belgium

  • Catharina Hospital, Hemato-Oncology

    Eindhoven, 5623 EJ, Netherlands

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    Saint-Etienne, 42270, France

  • Centro di Riferimento Oncologico di Aviano

    Avianno, 33081, Italy

  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200, Germany

  • Charité - Universitätsmedizin Berlin - Campus Charité Mitte

    Berlin, 10117, Germany

  • Clinique Victor Hugo

    Le Mans, 72015, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Universitario Navarra

    Pamplona, 31008, Spain

  • Das Diak

    Schwäbisch Hall, 74523, Germany

  • Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano

    Caserta, 81100, Italy

  • Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie

    Krefeld, 47805, Germany

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • GHM Institut Daniel Hollard

    Grenoble, 38000, France

  • Gemeinschaftpraxis Pott/Tirier/Hannig

    Bottrop, 46236, Germany

  • HELIOS Klinikum Berlin Buch

    Berlin, 13125, Germany

  • Helse Førde HF sentralsjukehuset

    Førde, 6807, Norway

  • Hospital Manises

    Valencia, 46940, Spain

  • Hospital Prive Sevigne

    Cesson-Sévigné, 35510, France

  • Hospital Prive de Villeneuve d'Ascq

    Villeneuve-d'Ascq, 59650, France

  • Hospital Santa Lucía

    Cartagena, 30202, Spain

  • Hospital Universitario Central Asturias

    Oviedo, 33011, Spain

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223, Spain

  • Hospital de Jaen

    Jaén, 23007, Spain

  • Hospital de Jerez

    Cadiz, 11408, Spain

  • Hämatologie / Internistische Onkologie

    Wiesbaden, 65189, Germany

  • Hôpital privé d'Antony - Ramsay Générale de Santé

    Antony, 92160, France

  • IP HULA

    Lugo, 27004, Spain

  • IRCCS Policlinico di Pavia

    Pavia, 27100, Italy

  • Innsbruck University Hospital

    Innsbruck, A-6020, Austria

  • Internistische Facharztzentrum mit Dialyse

    Memmingen, 87700, Germany

  • Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna

    Bologna, 40138, Italy

  • Kliniken Berlin Köpenick

    Berlin, 12559, Germany

  • Kliniken Villingen-Schwenningen

    Villingen-Schwenningen, 78052, Germany

  • Klinikum Magdeburg

    Magdeburg, 39130, Germany

  • Klinikum Nord, Klinik für Innere Medizin 5

    Nuremberg, 90419, Germany

  • Klinikum Sindelfingen, Med.Klinik I

    Sindelfingen, 71065, Germany

  • Klinikum St. Marien Amberg

    Amberg, 92224, Germany

  • Kreiskliniken Reutlingen

    Reutlingen, 72764, Germany

  • LKH Hochsteiermark

    Leoben, A-8700, Austria

  • Lahn-Dill-Kliniken

    Wetzlar, 35578, Germany

  • Lincoln County Hospital

    Lincoln, LN2 5QY, United Kingdom

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, 23562, Germany

  • MVZ Mitte - Onkologische Schwerpunktpraxis

    Leipzig, 4103, Germany

  • Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover

    Deggendorf, 94469, Germany

  • Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

    München, D-80639, Germany

  • Midlands Regional Hospital , Hematology/Oncology

    Country Offaly, R35 NY51, Ireland

  • Nij Smellinghe

    Drachten, 9202 NN, Netherlands

  • Norfolk and Norwich University Hospital

    Norfolk, NR4 7UY, United Kingdom

  • Northern Health and Social Care Trust -Antrim Area Hospital

    Antrim, BT41 2RL, United Kingdom

  • Odense Hospital

    Odense, 115000, Denmark

  • Onko-Log Mulheim Gbr

    Mülheim, 454680, Germany

  • Onkologicum Stuttgart

    Stuttgart, 70174, Germany

  • Onkologie Koln

    Cologne, 50677, Germany

  • Onkologische Praxis Oldenburg

    Oldenburg, 26121, Germany

  • Opsedale di Bolzano

    Milan, 39100, Italy

  • Ospdeale Policlinico Borgo Roma

    Verona, 37134, Italy

  • Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL

    Allessandria, 15121, Italy

  • Ospedale Belcolle Viterbo

    Viterbo, 1100, Italy

  • Ospedale Ivrea , Areas Medica

    Ivrea, 10015, Italy

  • Ospedale Maggiore di Novara

    Novara, 28100, Italy

  • Ospedale Sant'Eugenio

    Rome, 00-144, Italy

  • Ospedale dell'Angelo

    Mestre, 30121, Italy

  • Ospedale di Circolo di Busto Arsizio

    Busto Arsizio, 21052, Italy

  • Ospedale di Circolo, Fondazione Macchi

    Varese, 21100, Italy

  • Ospedale di Ivrea

    Chivasso, Corso Galileo Ferraris, 3 Chivasso, 10034, Italy

  • Policlinico Gemelli Roma

    Rome, 00-168, Italy

  • Polyclinique Bordeaux Nord Aquaitaine

    Bordeaux, 33300, France

  • Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust

    Cosham, PO6 3LY, United Kingdom

  • Rode Kruis Hospital

    Beverwijk, 1942 LE, Netherlands

  • Royal Stoke Hospital

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Röpcke-Zweers Hospital

    Hardenberg, 7772 SE, Netherlands

  • S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate

    Reggio Emilia, 42123, Italy

  • Servizio immunoematologia e medicina trasfusionale-ASP

    Ragusa, 97100, Italy

  • Skåne University Hospital, Lund

    Lund, 22185, Sweden

  • Son Espases

    Palma de Mallorca, 0-7120, Spain

  • South Eastern Health and Social Care Trust - The Ulster Hospital

    Belfast, BT16 1RH, United Kingdom

  • Southend Hospital

    Southend-on-Sea, SS0 0RY, United Kingdom

  • Southmead Hospital -North Bristol NHS Trust

    Bristol, BS10 5NB, United Kingdom

  • Sozialstiftung Bamberg

    Bamberg, 96040, Germany

  • St Georges Hospital

    London, SW17 0QT, United Kingdom

  • St. Bernward Krankenhaus GmbH

    Hildesheim, 31134, Germany

  • Stadt. Krankenhaus Kiel, 2.med Klinik,

    Kiel, 24116, Germany

  • Stauferklinikum

    Mutlangen, 73557, Germany

  • The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital

    Liverpool, L9 7AL, United Kingdom

  • UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro

    Nuoro, 8100, Italy

  • UO di Ematologia Osp. Mons Di Miccolis

    Barletta, 76121, Italy

  • UO di Ematologia Osp. Perrino

    Brindisi, 72100, Italy

  • UO di Ematologia Osp. S. Carlo - Potenza

    Potenza, 85100, Italy

  • UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita

    Rome, 153, Italy

  • UZ Gent

    Ghent, 9000, Belgium

  • Ueboroertliche Berugsausuebungsgemeinschaft

    Troisdorf, 53840, Germany

  • University Medical Center Utrecht

    Utrecht, 3584 CX, Netherlands

  • University hospital St. Pölten

    Pölten, A-3100, Austria

  • VieCuri Medical Center

    Venlo, 5912 BL, Netherlands

  • W8 Praxis für Onkologie

    Aachen, 52064, Germany

  • Waterford Regional Hospital, Waterford

    Waterford, X91 ER8E, Ireland

  • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

    Worcester, WR5 1DD, United Kingdom

  • Ziekehuis Oost Limburg

    Limbourg, 3600, Belgium

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