A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
- Registration Number
- NCT03106324
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 911
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TNE NDMM patients treated with lenalidomide regimen Revlimid (lenalidomide) 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 Revlimid (lenalidomide) Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide
- Primary Outcome Measures
Name Time Method Incidence of cardiovascular events Approximately 8 years Number of participants with cardiovascular adverse events
- Secondary Outcome Measures
Name Time Method Incidence of renal impairment in NDMM patients Approximately 8 years To document renal function among TNE NDMM patients treated with a first-line regimen
Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen Approximately 8 years Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.
Incidence of infections in NDMM patients Approximately 8 years To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
Trial Locations
- Locations (124)
AZ Nikolaas
🇧🇪Sint Niklass, Belgium
CHU du Mont-Godinne
🇧🇪Yvoir, Belgium
Nij Smellinghe
🇳🇱Drachten, Netherlands
Catharina Hospital, Hemato-Oncology
🇳🇱Eindhoven, Netherlands
Ziekehuis Oost Limburg
🇧🇪Limburg, Belgium
CHPLT Verviers
🇧🇪Verviers, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
CHU Ambroise Pare
🇧🇪Mons, Belgium
Midlands Regional Hospital , Hematology/Oncology
🇮🇪Country Offaly, Ireland
Röpcke-Zweers Hospital
🇳🇱Hardenberg, Netherlands
Innsbruck University Hospital
🇦🇹Innsbruck, Austria
UZ Gent
🇧🇪Gent, Belgium
Waterford Regional Hospital, Waterford
🇮🇪Waterford, Ireland
Helse Førde HF sentralsjukehuset
🇳🇴Førde, Norway
Akershus universitetssykehus HF
🇳🇴Lørenskog, Norway
Admiraal de Ruyter Hospital
🇳🇱Goes, Netherlands
Academic Hospital Maastricht
🇳🇱Maastricht, Netherlands
UO di Ematologia Osp. Perrino
🇮🇹Brindisi, Italy
AO Garibaldi Catania - Via Palermo 636
🇮🇹Catania, Italy
Ospedale Ivrea , Areas Medica
🇮🇹Ivrea, Italy
Ospedale dell'Angelo
🇮🇹Mestre, Italy
ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
🇮🇹Milano, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Opsedale di Bolzano
🇮🇹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
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
Ospedale di Circolo, Fondazione Macchi
🇮🇹Varese, Italy
CHU-Charleroi
🇧🇪Charleroi, Belgium
AZ Groeninge
🇧🇪Kortijk, Belgium
Hospital Prive Sevigne
🇫🇷Cesson-Sevigne, France
GHM Institut Daniel Hollard
🇫🇷Grenoble, France
Clinique Victor Hugo
🇫🇷Le Mans, France
LKH Hochsteiermark
🇦🇹Leoben, Austria
CHU Saint-Pierre
🇧🇪Bruxelles, Belgium
Ospedale di Ivrea
🇮🇹Chivasso, Corso Galileo Ferraris, 3 Chivasso, Italy
Centro di Riferimento Oncologico di Aviano
🇮🇹Avianno, Italy
Polyclinique Bordeaux Nord Aquaitaine
🇫🇷Bordeaux, France
CHR Orleans
🇫🇷Orléans, France
Hospital Prive de Villeneuve d'Ascq
🇫🇷Villeneuve d'Ascq, France
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
CHR Citadelle Liège
🇧🇪Liege, Belgium
Odense Hospital
🇩🇰Odense, Denmark
Hôpital privé d'Antony - Ramsay Générale de Santé
🇫🇷Antony, France
CH de Libourne
🇫🇷Libourne, France
CH Mont de Marsan
🇫🇷Mont de Marsan, France
CH St Jean
🇫🇷Perpignan, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
🇫🇷Saint-Etienne, France
UO di Ematologia Osp. Mons Di Miccolis
🇮🇹Barletta, Italy
Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
🇮🇹Allessandria, Italy
Ospedale di Circolo di Busto Arsizio
🇮🇹Busto Arsizio, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
UO di Ematologia Osp. S. Carlo - Potenza
🇮🇹Potenza, Italy
Servizio immunoematologia e medicina trasfusionale-ASP
🇮🇹Ragusa, Italy
UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
🇮🇹Rome, Italy
Ospedale Belcolle Viterbo
🇮🇹Viterbo, Italy
VieCuri Medical Center
🇳🇱Venlo, Netherlands
Rode Kruis Hospital
🇳🇱Beverwijk, Netherlands
Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
🇮🇹Bologna, Italy
Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
🇮🇹Caserta, Italy
"S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
🇮🇹Cagliari, Italy
AO Garibaldi Catania
🇮🇹Catania, Italy
Skåne University Hospital, Lund
🇸🇪Lund, Sweden
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom
Hospital Santa Lucía
🇪🇸Cartagena, Spain
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
St Georges Hospital
🇬🇧London, United Kingdom
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
🇬🇧Cosham, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norfolk, United Kingdom
Royal Stoke Hospital
🇬🇧Stoke-on-Trent, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
🇬🇧Liverpool, United Kingdom
Southend Hospital
🇬🇧Southend-on-Sea, United Kingdom
Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
🇩🇪Deggendorf, Germany
Onkologie Koln
🇩🇪Koln, Germany
Kliniken Berlin Köpenick
🇩🇪Berlin, Germany
St. Bernward Krankenhaus GmbH
🇩🇪Hildesheim, Germany
Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
🇩🇪Krefeld, Germany
Onko-Log Mulheim Gbr
🇩🇪Mulheim, Germany
Klinikum Magdeburg
🇩🇪Magdeburg, Germany
MVZ Mitte - Onkologische Schwerpunktpraxis
🇩🇪Leipzig, Germany
Internistische Facharztzentrum mit Dialyse
🇩🇪Memmingen, Germany
Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
🇩🇪Munchen, Germany
Stauferklinikum
🇩🇪Mutlangen, Germany
Klinikum Nord, Klinik für Innere Medizin 5
🇩🇪Nurnberg, Germany
Onkologische Praxis Oldenburg
🇩🇪Oldenburg, Germany
Das Diak
🇩🇪Schwabisch Hall, Germany
Ueboroertliche Berugsausuebungsgemeinschaft
🇩🇪Troisdorf, Germany
Klinikum Sindelfingen, Med.Klinik I
🇩🇪Sindelfingen, Germany
Onkologicum Stuttgart
🇩🇪Stuttgart, Germany
Lahn-Dill-Kliniken
🇩🇪Wetzlar, Germany
Hämatologie / Internistische Onkologie
🇩🇪Wiesbaden, Germany
Hospital de Jerez
🇪🇸Cadiz, Spain
IP HULA
🇪🇸Lugo, Spain
Hospital Manises
🇪🇸Valencia, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Madrid, Spain
Complejo Universitario Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Central Asturias
🇪🇸Oviedo, Spain
Kliniken Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Gemeinschaftpraxis Pott/Tirier/Hannig
🇩🇪Bottrop, Germany
HELIOS Klinikum Berlin Buch
🇩🇪Berlin, Germany
University hospital St. Pölten
🇦🇹Polten, Austria
Aalborg University Hospital
🇩🇰Aalborg, Denmark
CH Victor Dupouy
🇫🇷Argenteuil, France
CHU de Nice
🇫🇷Nice, France
Sozialstiftung Bamberg
🇩🇪Bamberg, Germany
Charité - Universitätsmedizin Berlin - Campus Charité Mitte
🇩🇪Berlin, Germany
W8 Praxis für Onkologie
🇩🇪Aachen, Germany
Klinikum St. Marien Amberg
🇩🇪Amberg, Germany
Stadt. Krankenhaus Kiel, 2.med Klinik,
🇩🇪Kiel, Germany
Lübecker Onkologische Schwerpunktpraxis
🇩🇪Lubeck, Germany
Kreiskliniken Reutlingen
🇩🇪Reutlingen, Germany
Ospdeale Policlinico Borgo Roma
🇮🇹Verona, Italy
Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital de Jaen
🇪🇸Jaen, Spain
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
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands