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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03106324 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Elisabeth Kueenburg, MD |
Principal Investigator Affiliation | Study physician for Celgene |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
: 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
Drug: - Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Innsbruck University Hospital
Innsbruck, , A-6020
Status
Recruiting
Address
LKH Hochsteiermark
Leoben, , A-8700
Status
Recruiting
Address
University hospital St. Pölten
Polten, , A-3100
Status
Not yet recruiting
Address
CHU Saint-Pierre
Bruxelles, , 1000
Status
Recruiting
Address
Cliniques Universitaires Saint-Luc
Bruxelles, , 1200
Status
Recruiting
Address
CHU-Charleroi
Bruxelles, , 6110
Status
Recruiting
Address
CHU-Charleroi
Charleroi, , 6042
Status
Recruiting
Address
UZ Gent
Gent, , 9000
Status
Recruiting
Address
AZ Groeninge
Kortijk, , 8500
Status
Recruiting
Address
CHR Citadelle Liège
Liege, , 4000
Status
Recruiting
Address
Ziekehuis Oost Limburg
Limburg, , 3600
Status
Terminated
Address
CHU Ambroise Pare
Mons, , 7000
Status
Recruiting
Address
AZ Nikolaas
Sint Niklass, , 9100
Status
Recruiting
Address
CHPLT Verviers
Verviers, , 4800
Status
Recruiting
Address
CHU du Mont-Godinne
Yvoir, , 5530
Status
Recruiting
Address
Aalborg University Hospital
Aalborg, , 9100
Status
Not yet recruiting
Address
Odense Hospital
Odense, , 115000
Status
Recruiting
Address
Hôpital privé d'Antony - Ramsay Générale de Santé
Antony, , 92160
Status
Recruiting
Address
CH Victor Dupouy
Argenteuil, , 95100
Status
Withdrawn
Address
Hospital Nord-Comte
Belfort, , 90015
Status
Recruiting
Address
Polyclinique Bordeaux Nord Aquaitaine
Bordeaux, , 33300
Status
Recruiting
Address
Hospital Prive Sevigne
Cesson-Sevigne, , 35510
Status
Recruiting
Address
GHM Institut Daniel Hollard
Grenoble, , 38000
Status
Recruiting
Address
Clinique Victor Hugo
Le Mans, , 72015
Status
Recruiting
Address
CH de Libourne
Libourne, , 33505
Status
Recruiting
Address
CH Mont de Marsan
Mont de Marsan, , 40000
Status
Recruiting
Address
CHU de Nice
Nice, , O6200
Status
Recruiting
Address
CHR Orleans
Orléans, , 45100
Status
Recruiting
Address
CH St Jean
Perpignan, , 66093
Status
Recruiting
Address
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Etienne, , 42270
Status
Recruiting
Address
Hospital Prive de Villeneuve d'Ascq
Villeneuve d'Ascq, , 59650
Status
Recruiting
Address
W8 Praxis für Onkologie
Aachen, , 52064
Status
Recruiting
Address
Klinikum St. Marien Amberg
Amberg, , 92224
Status
Recruiting
Address
Sozialstiftung Bamberg
Bamberg, , 96040
Status
Not yet recruiting
Address
Charité - Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, , 10117
Status
Recruiting
Address
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, , 12200
Status
Recruiting
Address
Kliniken Berlin Köpenick
Berlin, , 12559
Status
Recruiting
Address
HELIOS Klinikum Berlin Buch
Berlin, , 13125
Status
Not yet recruiting
Address
Gemeinschaftpraxis Pott/Tirier/Hannig
Bottrop, , 46236
Status
Recruiting
Address
Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
Deggendorf, , 94469
Status
Recruiting
Address
St. Bernward Krankenhaus GmbH
Hildesheim, , 31134
Status
Not yet recruiting
Address
Stadt. Krankenhaus Kiel, 2.med Klinik,
Kiel, , 24116
Status
Recruiting
Address
Onkologie Koln
Koln, , 50677
Status
Recruiting
Address
Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
Krefeld, , 47805
Status
Recruiting
Address
MVZ Mitte - Onkologische Schwerpunktpraxis
Leipzig, , 4103
Status
Recruiting
Address
Lübecker Onkologische Schwerpunktpraxis
Lubeck, , 23562
Status
Recruiting
Address
Klinikum Magdeburg
Magdeburg, , 39130
Status
Recruiting
Address
Internistische Facharztzentrum mit Dialyse
Memmingen, , 87700
Status
Recruiting
Address
Onko-Log Mulheim Gbr
Mulheim, , 454680
Status
Recruiting
Address
Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
Munchen, , D-80639
Status
Recruiting
Address
Stauferklinikum
Mutlangen, , 73557
Status
Withdrawn
Address
Dr. med. Christoph Losem Praxis für Onkologie und Hämatologie
Neuss, , 41462
Status
Recruiting
Address
Klinikum Nord, Klinik für Innere Medizin 5
Nurnberg, , 90419
Status
Recruiting
Address
Onkologische Praxis Oldenburg
Oldenburg, , 26121
Status
Recruiting
Address
Kreiskliniken Reutlingen
Reutlingen, , 72764
Status
Recruiting
Address
Das Diak
Schwabisch Hall, , 74523
Status
Recruiting
Address
Klinikum Sindelfingen, Med.Klinik I
Sindelfingen, , 71065
Status
Recruiting
Address
Onkologicum Stuttgart
Stuttgart, , 70174
Status
Recruiting
Address
Ueboroertliche Berugsausuebungsgemeinschaft
Troisdorf, , 53840
Status
Terminated
Address
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, , 78052
Status
Recruiting
Address
Lahn-Dill-Kliniken
Wetzlar, , 35578
Status
Not yet recruiting
Address
Hämatologie / Internistische Onkologie
Wiesbaden, , 65189
Status
Withdrawn
Address
überörtl. Gem. Praxis, Dr. med. Markus Klein und Olav Heringer
Wiesbaden, , 65189
Status
Recruiting
Address
Midlands Regional Hospital , Hematology/Oncology
Country Offaly, , R35 NY51
Status
Recruiting
Address
Waterford Regional Hospital, Waterford
Waterford, , X91 ER8E
Status
Not yet recruiting
Address
Ospedale di Ivrea
Chivasso, Corso Galileo Ferraris, 3 Chivasso, 10034
Status
Recruiting
Address
Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
Allessandria, , 15121
Status
Recruiting
Address
Centro di Riferimento Oncologico di Aviano
Avianno, , 33081
Status
Recruiting
Address
UO di Ematologia Osp. Mons Di Miccolis
Barletta, , 76121
Status
Recruiting
Address
Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
Bologna, , 40138
Status
Recruiting
Address
UO di Ematologia Osp. Perrino
Brindisi, , 72100
Status
Recruiting
Address
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, , 21052
Status
Recruiting
Address
"S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
Cagliari, , 0-9121
Status
Recruiting
Address
Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
Caserta, , 81100
Status
Recruiting
Address
AO Garibaldi Catania - Via Palermo 636
Catania, , 95122
Status
Not yet recruiting
Address
AO Garibaldi Catania
Catania, , 95122
Status
Withdrawn
Address
Ospedali a Cosenza
Cosenza, , 87100
Status
Recruiting
Address
Ospedale Ivrea , Areas Medica
Ivrea, , 10015
Status
Recruiting
Address
Ospedale dell'Angelo
Mestre, , 30121
Status
Not yet recruiting
Address
ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
Milano, , 20162
Status
Recruiting
Address
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, , 20122
Status
Recruiting
Address
ASST Grande Ospedale Metropolitano Niguarda
Milan, , 20162
Status
Recruiting
Address
Opsedale di Bolzano
Milan, , 39100
Status
Recruiting
Address
Ospedale Maggiore di Novara
Novara, , 28100
Status
Recruiting
Address
UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro
Nuoro, , 8100
Status
Recruiting
Address
IRCCS Policlinico di Pavia
Pavia, , 27100
Status
Recruiting
Address
UO di Ematologia Osp. S. Carlo - Potenza
Potenza, , 85100
Status
Recruiting
Address
Servizio immunoematologia e medicina trasfusionale-ASP
Ragusa, , 97100
Status
Recruiting
Address
S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
Reggio-Emilia, , 42123
Status
Recruiting
Address
A.O Bianchi Melacrino Morelli - Presidio Riuniti
Regio Calabria, , 89125
Status
Recruiting
Address
Ospedale Sant'Eugenio
Rome, , 00-144
Status
Recruiting
Address
Policlinico Gemelli Roma
Rome, , 00-168
Status
Recruiting
Address
UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
Rome, , 153
Status
Recruiting
Address
Ospedale di Circolo, Fondazione Macchi
Varese, , 21100
Status
Recruiting
Address
Ospdeale Policlinico Borgo Roma
Verona, , 37134
Status
Recruiting
Address
Ospedale Belcolle Viterbo
Viterbo, , 1100
Status
Recruiting
Address
Rode Kruis Hospital
Beverwijk, , 1942 LE
Status
Recruiting
Address
Nij Smellinghe
Drachten, , 9202 NN
Status
Recruiting
Address
Catharina Hospital, Hemato-Oncology
Eindhoven, , 5623 EJ
Status
Recruiting
Address
Admiraal de Ruyter Hospital
Goes, , 4462 RA
Status
Recruiting
Address
Röpcke-Zweers Hospital
Hardenberg, , 7772 SE
Status
Recruiting
Address
Academic Hospital Maastricht
Maastricht, , 3526 KV
Status
Recruiting
Address
University Medical Center Utrecht
Utrecht, , 3584 CX
Status
Recruiting
Address
VieCuri Medical Center
Venlo, , 5912 BL
Status
Withdrawn
Address
Isala Hospital
Zwolle, , 8025 AB
Status
Recruiting
Address
Helse Førde HF sentralsjukehuset
Førde, , 6807
Status
Recruiting
Address
Akershus universitetssykehus HF
Lørenskog, , 1478
Status
Recruiting
Address
Hospital de Jerez
Cadiz, , 11408
Status
Not yet recruiting
Address
Hospital Santa Lucía
Cartagena, , 30202
Status
Terminated
Address
Hospital de Jaen
Jaen, , 23007
Status
Recruiting
Address
IP HULA
Lugo, , 27004
Status
Recruiting
Address
Hospital Universitario Quironsalud Madrid
Madrid, , 28223
Status
Recruiting
Address
Hospital Universitario Central Asturias
Oviedo, , 33011
Status
Recruiting
Address
Son Espases
Palma de Mallorca, , 0-7120
Status
Recruiting
Address
Complejo Universitario Navarra
Pamplona, , 31008
Status
Recruiting
Address
Hospital Manises
Valencia, , 46940
Status
Not yet recruiting
Address
Skåne University Hospital, Lund
Lund, , 22185
Status
Withdrawn
Address
Skanes Universitetssjukhus Malmo
Malmo, , 214 21
Status
Recruiting
Address
Northern Health and Social Care Trust -Antrim Area Hospital
Antrim, , BT41 2RL
Status
Recruiting
Address
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, , BT16 1RH
Status
Not yet recruiting
Address
Birmingham Heartlands Hospital
Birmingham, , B9 5SS,
Status
Withdrawn
Address
Birmingham Heartlands Hospital
Birmingham, , B9 5SS
Status
Recruiting
Address
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
Bodelwyddan, , LL18 5UJ
Status
Recruiting
Address
Southmead Hospital -North Bristol NHS Trust
Bristol, , BS10 5NB
Status
Withdrawn
Address
Colchester General Hospital
Colchester, , CO4 5JL
Status
Recruiting
Address
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
Cosham, , PO6 3LY
Status
Withdrawn
Address
Beatson West of Scotland Cancer Centre
Glasgow, , G12 0YN
Status
Not yet recruiting
Address
Lincoln County Hospital
Lincoln, , LN2 5QY
Status
Recruiting
Address
Lincoln County Hospital
Lincoln, , LN2 5QY
Status
Recruiting
Address
The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
Liverpool, , L9 7AL
Status
Withdrawn
Address
London North West University Healthcare NHS Trust -Northwick Park Hospital
London, , HA1 3UJ
Status
Recruiting
Address
St Georges Hospital
London, , SW17 0QT
Status
Recruiting
Address
Norfolk and Norwich University Hospital
Norfolk, , NR4 7UY
Status
Withdrawn
Address
Royal Hallamshire Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , S10 2JF
Status
Not yet recruiting
Address
Southend Hospital
Southend-on-Sea, , SS0 0RY
Status
Withdrawn
Address
Southend Hospital
Southend-on-Sea, , SS0 0RY
Status
Not yet recruiting
Address
Royal Stoke Hospital
Stoke-on-Trent, , ST4 6QG
Status
Recruiting
Address
Royal Stoke Hospital
Stoke-on-Trent, , ST4 6QG
Status
Recruiting
Address
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, , WR5 1DD