A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
NCT ID: NCT03106324
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
911 participants
OBSERVATIONAL
2017-03-31
2026-01-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma
NCT00306813
Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma
NCT02155634
Maintenance Therapy Using Lenalidomide in Myeloma
NCT00430365
Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM
NCT02112175
Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT00445484
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TNE NDMM patients treated with lenalidomide regimen
Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide
Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
TNE NDMM patients treated with non-lenalidomide
Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide
Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb, MD
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Innsbruck University Hospital
Innsbruck, , Austria
LKH Hochsteiermark
Leoben, , Austria
University hospital St. Pölten
Pölten, , Austria
CHU Saint-Pierre
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
CHU-Charleroi
Brussels, , Belgium
CHU-Charleroi
Charleroi, , Belgium
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortijk, , Belgium
CHR Citadelle Liège
Liège, , Belgium
Ziekehuis Oost Limburg
Limbourg, , Belgium
CHU Ambroise Pare
Mons, , Belgium
AZ Nikolaas
Sint Niklass, , Belgium
CHPLT Verviers
Verviers, , Belgium
CHU du Mont-Godinne
Yvoir, , Belgium
Aalborg University Hospital
Aalborg, , Denmark
Odense Hospital
Odense, , Denmark
Hôpital privé d'Antony - Ramsay Générale de Santé
Antony, , France
CH Victor Dupouy
Argenteuil, , France
Polyclinique Bordeaux Nord Aquaitaine
Bordeaux, , France
Hospital Prive Sevigne
Cesson-Sévigné, , France
GHM Institut Daniel Hollard
Grenoble, , France
Clinique Victor Hugo
Le Mans, , France
CH de Libourne
Libourne, , France
CH Mont de Marsan
Mont-de-Marsan, , France
CHU de Nice
Nice, , France
CHR Orleans
Orléans, , France
CH St Jean
Perpignan, , France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Etienne, , France
Hospital Prive de Villeneuve d'Ascq
Villeneuve-d'Ascq, , France
W8 Praxis für Onkologie
Aachen, , Germany
Klinikum St. Marien Amberg
Amberg, , Germany
Sozialstiftung Bamberg
Bamberg, , Germany
Charité - Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, , Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Kliniken Berlin Köpenick
Berlin, , Germany
HELIOS Klinikum Berlin Buch
Berlin, , Germany
Gemeinschaftpraxis Pott/Tirier/Hannig
Bottrop, , Germany
Onkologie Koln
Cologne, , Germany
Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
Deggendorf, , Germany
St. Bernward Krankenhaus GmbH
Hildesheim, , Germany
Stadt. Krankenhaus Kiel, 2.med Klinik,
Kiel, , Germany
Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
Krefeld, , Germany
MVZ Mitte - Onkologische Schwerpunktpraxis
Leipzig, , Germany
Lübecker Onkologische Schwerpunktpraxis
Lübeck, , Germany
Klinikum Magdeburg
Magdeburg, , Germany
Internistische Facharztzentrum mit Dialyse
Memmingen, , Germany
Stauferklinikum
Mutlangen, , Germany
Onko-Log Mulheim Gbr
Mülheim, , Germany
Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
München, , Germany
Klinikum Nord, Klinik für Innere Medizin 5
Nuremberg, , Germany
Onkologische Praxis Oldenburg
Oldenburg, , Germany
Kreiskliniken Reutlingen
Reutlingen, , Germany
Das Diak
Schwäbisch Hall, , Germany
Klinikum Sindelfingen, Med.Klinik I
Sindelfingen, , Germany
Onkologicum Stuttgart
Stuttgart, , Germany
Ueboroertliche Berugsausuebungsgemeinschaft
Troisdorf, , Germany
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Lahn-Dill-Kliniken
Wetzlar, , Germany
Hämatologie / Internistische Onkologie
Wiesbaden, , Germany
Midlands Regional Hospital , Hematology/Oncology
Country Offaly, , Ireland
Waterford Regional Hospital, Waterford
Waterford, , Ireland
Ospedale di Ivrea
Chivasso, Corso Galileo Ferraris, 3 Chivasso, Italy
Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
Allessandria, , Italy
Centro di Riferimento Oncologico di Aviano
Avianno, , Italy
UO di Ematologia Osp. Mons Di Miccolis
Barletta, , Italy
Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
Bologna, , Italy
UO di Ematologia Osp. Perrino
Brindisi, , Italy
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, , Italy
"S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
Cagliari, , Italy
Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
Caserta, , Italy
AO Garibaldi Catania - Via Palermo 636
Catania, , Italy
AO Garibaldi Catania
Catania, , Italy
Ospedale Ivrea , Areas Medica
Ivrea, , Italy
Ospedale dell'Angelo
Mestre, , Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Opsedale di Bolzano
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
Milan, , Italy
Ospedale Maggiore di Novara
Novara, , Italy
UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro
Nuoro, , Italy
IRCCS Policlinico di Pavia
Pavia, , Italy
UO di Ematologia Osp. S. Carlo - Potenza
Potenza, , Italy
Servizio immunoematologia e medicina trasfusionale-ASP
Ragusa, , Italy
S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
Reggio Emilia, , Italy
A.O Bianchi Melacrino Morelli - Presidio Riuniti
Regio Calabria, , Italy
Ospedale Sant'Eugenio
Rome, , Italy
Policlinico Gemelli Roma
Rome, , Italy
UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
Rome, , Italy
Ospedale di Circolo, Fondazione Macchi
Varese, , Italy
Ospdeale Policlinico Borgo Roma
Verona, , Italy
Ospedale Belcolle Viterbo
Viterbo, , Italy
Rode Kruis Hospital
Beverwijk, , Netherlands
Nij Smellinghe
Drachten, , Netherlands
Catharina Hospital, Hemato-Oncology
Eindhoven, , Netherlands
Admiraal de Ruyter Hospital
Goes, , Netherlands
Röpcke-Zweers Hospital
Hardenberg, , Netherlands
Academic Hospital Maastricht
Maastricht, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
VieCuri Medical Center
Venlo, , Netherlands
Helse Førde HF sentralsjukehuset
Førde, , Norway
Akershus universitetssykehus HF
Lørenskog, , Norway
Hospital de Jerez
Cadiz, , Spain
Hospital Santa Lucía
Cartagena, , Spain
Hospital de Jaen
Jaén, , Spain
IP HULA
Lugo, , Spain
Hospital Universitario Quironsalud Madrid
Madrid, , Spain
Hospital Universitario Central Asturias
Oviedo, , Spain
Son Espases
Palma de Mallorca, , Spain
Complejo Universitario Navarra
Pamplona, , Spain
Hospital Manises
Valencia, , Spain
Skåne University Hospital, Lund
Lund, , Sweden
Northern Health and Social Care Trust -Antrim Area Hospital
Antrim, , United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
Bodelwyddan, , United Kingdom
Southmead Hospital -North Bristol NHS Trust
Bristol, , United Kingdom
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
Cosham, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
Liverpool, , United Kingdom
St Georges Hospital
London, , United Kingdom
Norfolk and Norwich University Hospital
Norfolk, , United Kingdom
Southend Hospital
Southend-on-Sea, , United Kingdom
Royal Stoke Hospital
Stoke-on-Trent, , United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1194-5810
Identifier Type: OTHER
Identifier Source: secondary_id
CC-5013-MM-034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.