Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
- Registration Number
- NCT02279654
- Lead Sponsor
- Celgene
- Brief Summary
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 \[del(5q)\].
The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
- Are ≥ 18 years old at the time of signing the Informed consent form (ICF)
- Are transfusion dependent or have an history of transfusion dependence; for the purpose of the current Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS), transfusion-dependence is defined as requiring ≥2 RBC units over an 8 week period prior to the date of signature on the ICF (due to MDS-related causes and not because of hemorrhage, trauma, or other acute cause)
- Are on active treatment with lenalidomide (Lenalidomide Cohort) or have never been exposed to lenalidomide at the time of signing the ICF (Background Cohort)
- Have confirmed diagnosis of IPSS low or intermediate-1-risk MDS with isolated del (5q) (with morphological and cytogenetic information) diagnosed on 15 June 2007 (date of Revlimid first approved in Europe) or later
- Refuse to participate in the Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS),
- Are currently participating in an interventional therapeutic clinical trial for MDS (except for erythropoiesis-stimulating agents [ESAs] and granulocyte colonystimulating growth factors)
- Receive any investigational agent the time of signing the ICF
- Have previously been treated with lenalidomide and are no longer on active treatment with lenalidomide at the time of signing the ICF
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lenalidomide Population Lenalidomide Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal Background Population Lenalidomide All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal
- Primary Outcome Measures
Name Time Method Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid Up to 3 years Incidence, as well as the attributable risk (AR) and AR percent (%). Progressive Disease criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide Up to 3 years Number of MDS participants who survive
- Secondary Outcome Measures
Name Time Method Evaluate risk factors associated with progression of AML Up to 3 years Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide
Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide Up to 3 years Number of MDS participants who survive who have never been treated with Lenalidomide
Clinical practice Up to 3 years Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients in MDS participants
Adverse Events Up to 3 years Type, frequency, severity of advere events and relationship of adverse events to Lenalidomide. An adverse ecent is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, ie, any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product
Trial Locations
- Locations (146)
Local Institution - 0002
🇺🇸Centre City, New Jersey, United States
Local Institution - France
🇺🇸No City Provided, New Jersey, United States
Local Institution - 0001
🇺🇸Centre City, New Jersey, United States
Local Institution - Denmark
🇺🇸No City Provided, New Jersey, United States
Local Institution - Belgium
🇺🇸No City Provided, New Jersey, United States
Local Institution - Germany
🇺🇸No City Provided, New Jersey, United States
Local Institution - Greece
🇺🇸No City Provided, New Jersey, United States
CHU Hôtel Dieu
🇫🇷Angers, France
Hopital de L'archet I
🇫🇷Nice, Alpes-Maritimes, France
Rokslide Hospital
🇩🇰Roskilde, Denmark
CHU Nancy Brabois Adultes - 58 Allee dy morvan
🇫🇷Vandoeuvre les Nancy, France
Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach
🇩🇪Lebach, Germany
Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen
🇩🇪Tübingen, Germany
University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Monkton, Wishaw and Hairmyres Hospitals
🇬🇧East Kilbride, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
University Hospital South Manc
🇬🇧Manchester, United Kingdom
Hôpital St Louis
🇫🇷Paris, France
Maidstone Hospital
🇬🇧Maidstone, Kent, United Kingdom
U.O .C di Oncoematologia
🇮🇹Mirano, Italy
Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
Univesita La Sapienza
🇮🇹Roma, Italy
Ospedale Civile Santo Spirito
🇮🇹Pescara, Italy
Presidio Ospedaliero "A. Torto
🇮🇹Salerno, Italy
Policlinico "G.B. Rossi" Verona
🇮🇹Veneto, Italy
Local Institution - Italy
🇺🇸No City Provided, New Jersey, United States
Local Institution - Luxembourg
🇺🇸No City Provided, New Jersey, United States
Local Institution - Norway
🇺🇸No City Provided, New Jersey, United States
Århus University Hospital
🇩🇰Aarhus, Denmark
Local Institution - Spain
🇺🇸No City Provided, New Jersey, United States
Local Institution - Sweden
🇺🇸No City Provided, New Jersey, United States
AZ Klina
🇧🇪Brasschaat, Belgium
Local Institution - UK
🇺🇸No City Provided, New Jersey, United States
AZ Sint Jan
🇧🇪Brugge, Belgium
CHU Vésale
🇧🇪Montigny- le- tilleul, Belgium
GHdCharleroi
🇧🇪Charleroi, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
CHR Citadelle
🇧🇪Liège, Belgium
Clinique Saint-Pierre Ottignie
🇧🇪Ottignies, Belgium
Odense University Hospital
🇩🇰Odense, Denmark
Aalborg Sygehus, Dept of Hematology
🇩🇰Aalborg, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
CHU Haut-Lévêque
🇫🇷Pessac, Gironde, France
Institut Paoli Calmettes
🇫🇷Marseille, Bouches-du-Rhône, France
Centre Hospitalier D'Avignon - Hopital Henri Duffaut
🇫🇷Avignon, France
CH Chalon/Saone William Morey
🇫🇷Chalon Sur Saone, France
CHU Grenoble
🇫🇷La Tronche, France
CHRU De Lille - Hôpital Claude - Rue Michel Polonovski
🇫🇷Lille, France
Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt
🇫🇷Limoges, France
CHU Hôtel Dieu - Place A Ricordeau
🇫🇷Nantes, France
Centre Hospitalier Lyon-SUD [U
🇫🇷Pierre- Bénite, France
Hopital de Hautepierre CHRU de Strasbourg
🇫🇷Strasbourg, France
Hopital Purpan-Place du Dr. Baylac
🇫🇷Toulouse, France
CHU Bretonneau
🇫🇷Tours, France
Gemeinschaftspraxis Hämatologie-Onkologie
🇩🇪Dresden, Germany
Onkologische Schwerpunktpraxis Bielefeld
🇩🇪Bielefeld, Germany
Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center
🇩🇪Chemnitz, Germany
HELIOS St. Johannes Klinik
🇩🇪Duisburg, Germany
St Antonius Hospital (SAH)
🇩🇪Eschweiler, Germany
Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
🇩🇪Düsseldorf, Germany
Universitätsklinik Carl-Gustav
🇩🇪Dresden, Germany
Marien Hospital Düsseldorf
🇩🇪Düsseldorf, Germany
Kreiskrankenhaus St. Elisabeth - Von Werth-Str.
🇩🇪Grevenbroich, Germany
Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Institut für Versorgungsforschung in der Onkologie
🇩🇪Koblenz, Germany
InVO Institut fur Versorgungsforschung
🇩🇪Koblenz, Germany
Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig
🇩🇪Leipzig, Germany
Gesellschaft für Medizinische
🇩🇪Mönchengladbach, Germany
MLL Münchner Leukämielabor GmbH
🇩🇪München, Germany
III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim
🇩🇪Mannheim, Germany
III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
🇩🇪München, Germany
Klinik für Innere Medizin III
🇩🇪Ulm, Germany
Rems-Murr-Klinikum Winnenden
🇩🇪Winnenden, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
🇩🇪Westerstede, Germany
General Hospital of Athens - LAIKO
🇬🇷Athens, Greece
University General Hospital
🇬🇷Athens, Greece
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg
🇩🇪Würzburg, Germany
University Hospital Of Herakli
🇬🇷Herakleion - Crete, Greece
Georgios Gennimatos General Hospital
🇬🇷Athens, Greece
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
University General Hospital of Larissa
🇬🇷Larissa, Greece
G. Papanikolaou General Hospital
🇬🇷Thessaloniki, Greece
Irccs Crob
🇮🇹Rionero in Vulture, Potenza, Italy
University General Hospital of Patras
🇬🇷Patras, Greece
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
🇮🇹Ancona, Italy
Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS
🇮🇹Bergamo, Italy
AOU Careggi
🇮🇹Firenze, Italy
U.O Ematologia con Trapianto
🇮🇹Bari, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna
🇮🇹Bologna, Italy
Ospedale di Castelfranco Venet
🇮🇹Castelfranco Veneto, Treviso, Italy
AO Spedali Civili di Brescia
🇮🇹Brescia, Italy
Policlinico di Catania
🇮🇹Catania, Italy
Azienda ospedaliero-universita
🇮🇹Parma, Italy
Ospedale S. Luigi Gonzaga
🇮🇹Orbassano, Italy
Arcispedale S.Maria Nuova
🇮🇹Reggio Emilia, Italy
U.O Ematologia Azienda Ospedaliera
🇮🇹Regio Calabria, Italy
Azienda Ospedaliera Universitaria di Sassari
🇮🇹Sassari, Italy
AOU Policlinico Tor Vergata, Università Roma Tor Vergata
🇮🇹Roma, Italy
A.O. Citta' della Salute e del
🇮🇹Torino, Italy
Hospital Universitario de Gran Canaria Servicio de Hematología y
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología
🇪🇸Santander, Cantabria, Spain
Haukeland Sykehus
🇳🇴Bergen, Norway
Hospital costa del sol
🇪🇸Marbella, Málaga, Spain
Hospital de Cruces
🇪🇸Barakaldo, Spain
H.U. Ribera de Alzira
🇪🇸Alzira, Spain
Instit Catalia D'Oncologia
🇪🇸Barcelona, Spain
Hospital Virgen de Las Nieves
🇪🇸Grenada, Spain
Department of Hematology, Hospital Duran i Reynals
🇪🇸LLobregat, Spain
Hospital del Mar,Hematologia Hemotheropia
🇪🇸Barcelona, Spain
Pauc Tauli
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
H. Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Reina Sofia
🇪🇸Cordoba, Spain
Hospital Josep Trueta (ICO Girona)
🇪🇸Girona, Spain
Hospital Universitario central de Asturias
🇪🇸Oviedo, Spain
Hopsital Nuestra Senora de Valme
🇪🇸Sevilla, Spain
Univesity Hospital de Salamanca
🇪🇸Salamenca, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Son Espaces
🇪🇸Mallorca, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospiral Universitario de la Fe
🇪🇸Valencia, Spain
Länssjukhuset Kalmar
🇸🇪Kalmar, Sweden
Karolinska University Hopsital
🇸🇪Stockholm, Sweden
Lund University Hospital - Lasarettsgatan 23
🇸🇪Lund, Sweden
Aberdeen Royal Infirmary - Foresterhill Road
🇬🇧Aberdeen, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Pilgrim Hospital
🇬🇧Boston, United Kingdom
Basildon and Thurrock Hospitals
🇬🇧Essex, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, United Kingdom
Broomfield Hospital - Mid-Essex Hospitals NHS Trust
🇬🇧Essex, United Kingdom
Aintree Hospital - Longmoor Lane
🇬🇧Liverpool, United Kingdom
Lincoln county Hospital
🇬🇧Lincoln, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
Radcliffe Hospitals and University - Headley Way, Headington
🇬🇧Oxford, United Kingdom
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hopsital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario fundacion Jiminez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octobre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
H Universitario Puera de Hierro
🇪🇸Madrid, Spain