A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])
2 other identifiers
observational
911
12 countries
125
Brief Summary
This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedStudy Start
First participant enrolled
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2026
CompletedNovember 24, 2025
November 1, 2025
8.7 years
March 29, 2017
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of cardiovascular events
Number of participants with cardiovascular adverse events
Approximately 8 years
Secondary Outcomes (3)
Incidence of renal impairment in NDMM patients
Approximately 8 years
Incidence of infections in NDMM patients
Approximately 8 years
Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen
Approximately 8 years
Study Arms (2)
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
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
Interventions
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
Eligibility Criteria
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.
You may qualify if:
- Must have understood and voluntarily signed the Informed Consent Form (ICF)
- Age ≥ 18 years at the time of signing the ICF
- Newly diagnosed with multiple myeloma
- Must not be eligible for transplant
- 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.
You may not qualify if:
- 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.
- 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
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (125)
Innsbruck University Hospital
Innsbruck, A-6020, Austria
LKH Hochsteiermark
Leoben, A-8700, Austria
University hospital St. Pölten
Pölten, A-3100, Austria
CHU Saint-Pierre
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
CHU-Charleroi
Brussels, 6110, Belgium
CHU-Charleroi
Charleroi, 6042, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortijk, 8500, Belgium
CHR Citadelle Liège
Liège, 4000, Belgium
Ziekehuis Oost Limburg
Limbourg, 3600, Belgium
CHU Ambroise Pare
Mons, 7000, Belgium
AZ Nikolaas
Sint Niklass, 9100, Belgium
CHPLT Verviers
Verviers, 4800, Belgium
CHU du Mont-Godinne
Yvoir, 5530, Belgium
Aalborg University Hospital
Aalborg, 9100, Denmark
Odense Hospital
Odense, 115000, Denmark
Hôpital privé d'Antony - Ramsay Générale de Santé
Antony, 92160, France
CH Victor Dupouy
Argenteuil, 95100, France
Polyclinique Bordeaux Nord Aquaitaine
Bordeaux, 33300, France
Hospital Prive Sevigne
Cesson-Sévigné, 35510, France
GHM Institut Daniel Hollard
Grenoble, 38000, France
Clinique Victor Hugo
Le Mans, 72015, France
CH de Libourne
Libourne, 33505, France
CH Mont de Marsan
Mont-de-Marsan, 40000, France
CHU de Nice
Nice, O6200, France
CHR Orleans
Orléans, 45100, France
CH St Jean
Perpignan, 66093, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Etienne, 42270, France
Hospital Prive de Villeneuve d'Ascq
Villeneuve-d'Ascq, 59650, France
W8 Praxis für Onkologie
Aachen, 52064, Germany
Klinikum St. Marien Amberg
Amberg, 92224, Germany
Sozialstiftung Bamberg
Bamberg, 96040, Germany
Charité - Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, 10117, Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200, Germany
Kliniken Berlin Köpenick
Berlin, 12559, Germany
HELIOS Klinikum Berlin Buch
Berlin, 13125, Germany
Gemeinschaftpraxis Pott/Tirier/Hannig
Bottrop, 46236, Germany
Onkologie Koln
Cologne, 50677, Germany
Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
Deggendorf, 94469, Germany
St. Bernward Krankenhaus GmbH
Hildesheim, 31134, Germany
Stadt. Krankenhaus Kiel, 2.med Klinik,
Kiel, 24116, Germany
Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
Krefeld, 47805, Germany
MVZ Mitte - Onkologische Schwerpunktpraxis
Leipzig, 4103, Germany
Lübecker Onkologische Schwerpunktpraxis
Lübeck, 23562, Germany
Klinikum Magdeburg
Magdeburg, 39130, Germany
Internistische Facharztzentrum mit Dialyse
Memmingen, 87700, Germany
Stauferklinikum
Mutlangen, 73557, Germany
Onko-Log Mulheim Gbr
Mülheim, 454680, Germany
Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
München, D-80639, Germany
Klinikum Nord, Klinik für Innere Medizin 5
Nuremberg, 90419, Germany
Onkologische Praxis Oldenburg
Oldenburg, 26121, Germany
Kreiskliniken Reutlingen
Reutlingen, 72764, Germany
Das Diak
Schwäbisch Hall, 74523, Germany
Klinikum Sindelfingen, Med.Klinik I
Sindelfingen, 71065, Germany
Onkologicum Stuttgart
Stuttgart, 70174, Germany
Ueboroertliche Berugsausuebungsgemeinschaft
Troisdorf, 53840, Germany
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, 78052, Germany
Lahn-Dill-Kliniken
Wetzlar, 35578, Germany
Hämatologie / Internistische Onkologie
Wiesbaden, 65189, Germany
Midlands Regional Hospital , Hematology/Oncology
Country Offaly, R35 NY51, Ireland
Waterford Regional Hospital, Waterford
Waterford, X91 ER8E, Ireland
Ospedale di Ivrea
Chivasso, Corso Galileo Ferraris, 3 Chivasso, 10034, Italy
Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
Allessandria, 15121, Italy
Centro di Riferimento Oncologico di Aviano
Avianno, 33081, Italy
UO di Ematologia Osp. Mons Di Miccolis
Barletta, 76121, Italy
Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
Bologna, 40138, Italy
UO di Ematologia Osp. Perrino
Brindisi, 72100, Italy
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, 21052, Italy
"S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
Cagliari, 0-9121, Italy
Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
Caserta, 81100, Italy
AO Garibaldi Catania - Via Palermo 636
Catania, 95122, Italy
AO Garibaldi Catania
Catania, 95122, Italy
Ospedale Ivrea , Areas Medica
Ivrea, 10015, Italy
Ospedale dell'Angelo
Mestre, 30121, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Opsedale di Bolzano
Milan, 39100, Italy
ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
Milan, 20162, Italy
Ospedale Maggiore di Novara
Novara, 28100, Italy
UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro
Nuoro, 8100, Italy
IRCCS Policlinico di Pavia
Pavia, 27100, Italy
UO di Ematologia Osp. S. Carlo - Potenza
Potenza, 85100, Italy
Servizio immunoematologia e medicina trasfusionale-ASP
Ragusa, 97100, Italy
S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
Reggio Emilia, 42123, Italy
A.O Bianchi Melacrino Morelli - Presidio Riuniti
Regio Calabria, 89125, Italy
Ospedale Sant'Eugenio
Rome, 00-144, Italy
Policlinico Gemelli Roma
Rome, 00-168, Italy
UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
Rome, 153, Italy
Ospedale di Circolo, Fondazione Macchi
Varese, 21100, Italy
Ospdeale Policlinico Borgo Roma
Verona, 37134, Italy
Ospedale Belcolle Viterbo
Viterbo, 1100, Italy
Rode Kruis Hospital
Beverwijk, 1942 LE, Netherlands
Nij Smellinghe
Drachten, 9202 NN, Netherlands
Catharina Hospital, Hemato-Oncology
Eindhoven, 5623 EJ, Netherlands
Admiraal de Ruyter Hospital
Goes, 4462 RA, Netherlands
Röpcke-Zweers Hospital
Hardenberg, 7772 SE, Netherlands
Academic Hospital Maastricht
Maastricht, 3526 KV, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
VieCuri Medical Center
Venlo, 5912 BL, Netherlands
Helse Førde HF sentralsjukehuset
Førde, 6807, Norway
Akershus universitetssykehus HF
Lørenskog, 1478, Norway
Hospital de Jerez
Cadiz, 11408, Spain
Hospital Santa Lucía
Cartagena, 30202, Spain
Hospital de Jaen
Jaén, 23007, Spain
IP HULA
Lugo, 27004, Spain
Hospital Universitario Quironsalud Madrid
Madrid, 28223, Spain
Hospital Universitario Central Asturias
Oviedo, 33011, Spain
Son Espases
Palma de Mallorca, 0-7120, Spain
Complejo Universitario Navarra
Pamplona, 31008, Spain
Hospital Manises
Valencia, 46940, Spain
Skåne University Hospital, Lund
Lund, 22185, Sweden
Northern Health and Social Care Trust -Antrim Area Hospital
Antrim, BT41 2RL, United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, BT16 1RH, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS,, United Kingdom
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ, United Kingdom
Southmead Hospital -North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
Cosham, PO6 3LY, United Kingdom
Lincoln County Hospital
Lincoln, LN2 5QY, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
Liverpool, L9 7AL, United Kingdom
St Georges Hospital
London, SW17 0QT, United Kingdom
Norfolk and Norwich University Hospital
Norfolk, NR4 7UY, United Kingdom
Southend Hospital
Southend-on-Sea, SS0 0RY, United Kingdom
Royal Stoke Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, WR5 1DD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb, MD
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 10, 2017
Study Start
March 31, 2017
Primary Completion
December 12, 2025
Study Completion
January 13, 2026
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share