Clinical trial NCT02279654: Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
Official title: A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: Lenalidomide
Revlimid
Transfusion-dependent
international Prognostic Scoring System (IPSS) low
Intermediate-1-risk
MDS
Isolated del(5q)
Prospective
Non-interventional
Post-authorization safety study (PASS)
Disease registry
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received at least 1 dose of any treatment or treatment modality after the patient signs the informed consent form

* Lenalidomide cohort: All patients treated with lenalidomide
* Background cohort: All patients treated with therapeutic modalities other than lenalidomide

For each population 3 datasets will be described and will form the basis of subsequent analyses:

* A baseline demographic dataset ("population dataset")
* An exposure dataset
* An outcome dataset

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Up to 3 years
measure: Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide
timeFrame: Up to 3 years
measure: Adverse Events
timeFrame: Up to 3 years
measure: Evaluate risk factors associated with progression of AML
timeFrame: Up to 3 years
measure: Clinical practice
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Centre City
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Centre City
country: United States
facility: Local Institution - 0002
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Belgium
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Denmark
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - France
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Germany
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Greece
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Italy
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Luxembourg
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Norway
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Spain
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - Sweden
state: New Jersey
city: No City Provided
country: United States
facility: Local Institution - UK
state: New Jersey
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Charleroi
country: Belgium
facility: GHdCharleroi
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: CHR Citadelle
city: Montigny- le- tilleul
country: Belgium
facility: CHU Vésale
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre Ottignie
city: Aalborg
country: Denmark
facility: Aalborg Sygehus, Dept of Hematology
city: Aarhus
country: Denmark
facility: Århus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Rokslide Hospital
city: Nice
country: France
facility: Hopital de L'archet I
state: Alpes-Maritimes
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches-du-Rhône
city: Pessac
country: France
facility: CHU Haut-Lévêque
state: Gironde
city: Nantes cedex 01
country: France
facility: CHU Hôtel Dieu
state: Loire-Atlantique
city: Angers
country: France
facility: CHU Hôtel Dieu
city: Avignon
country: France
facility: Centre Hospitalier D'Avignon - Hopital Henri Duffaut
city: Chalon Sur Saone
country: France
facility: CH Chalon/Saone William Morey
city: La Tronche
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU De Lille - Hôpital Claude - Rue Michel Polonovski
city: Limoges
country: France
facility: Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt
city: Nantes
country: France
facility: CHU Hôtel Dieu - Place A Ricordeau
city: Paris
country: France
facility: Hôpital St Louis
city: Pierre- Bénite
country: France
facility: Centre Hospitalier Lyon-SUD [U
city: Strasbourg
country: France
facility: Hopital de Hautepierre CHRU de Strasbourg
city: Toulouse
country: France
facility: Hopital Purpan-Place du Dr. Baylac
city: Tours
country: France
facility: CHU Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: CHU Nancy Brabois Adultes - 58 Allee dy morvan
city: Bielefeld
country: Germany
facility: Onkologische Schwerpunktpraxis Bielefeld
city: Chemnitz
country: Germany
facility: Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie-Onkologie
city: Dresden
country: Germany
facility: Universitätsklinik Carl-Gustav
city: Duisburg
country: Germany
facility: HELIOS St. Johannes Klinik
city: Düsseldorf
country: Germany
facility: Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
city: Düsseldorf
country: Germany
facility: Marien Hospital Düsseldorf
city: Eschweiler
country: Germany
facility: St Antonius Hospital (SAH)
city: Grevenbroich
country: Germany
facility: Kreiskrankenhaus St. Elisabeth - Von Werth-Str.
city: Hamburg
country: Germany
facility: Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Koblenz
country: Germany
facility: Institut für Versorgungsforschung in der Onkologie
city: Koblenz
country: Germany
facility: InVO Institut fur Versorgungsforschung
city: Lebach
country: Germany
facility: Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach
city: Leipzig
country: Germany
facility: Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig
city: Mannheim
country: Germany
facility: III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim
city: Mönchengladbach
country: Germany
facility: Gesellschaft für Medizinische
city: München
country: Germany
facility: MLL Münchner Leukämielabor GmbH
city: München
country: Germany
facility: III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Tübingen
country: Germany
facility: Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen
city: Ulm
country: Germany
facility: Klinik für Innere Medizin III
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Winnenden
country: Germany
facility: Rems-Murr-Klinikum Winnenden
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Würzburg
country: Germany
facility: ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: General Hospital of Athens - LAIKO
city: Athens
country: Greece
facility: University General Hospital
city: Athens
country: Greece
facility: Georgios Gennimatos General Hospital
city: Herakleion - Crete
country: Greece
facility: University Hospital Of Herakli
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: G. Papanikolaou General Hospital
city: Rionero in Vulture
country: Italy
facility: Irccs Crob
state: Potenza
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Venet
state: Treviso
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
city: Bari
country: Italy
facility: U.O Ematologia con Trapianto
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi, AOU di Bologna
city: Brescia
country: Italy
facility: AO Spedali Civili di Brescia
city: Catania
country: Italy
facility: Policlinico di Catania
city: Firenze
country: Italy
facility: AOU Careggi
city: Mirano
country: Italy
facility: U.O .C di Oncoematologia
city: Orbassano
country: Italy
facility: Ospedale S. Luigi Gonzaga
city: Parma
country: Italy
facility: Azienda ospedaliero-universita
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito
city: Reggio Emilia
country: Italy
facility: Arcispedale S.Maria Nuova
city: Regio Calabria
country: Italy
facility: U.O Ematologia Azienda Ospedaliera
city: Roma
country: Italy
facility: Univesita La Sapienza
city: Roma
country: Italy
facility: AOU Policlinico Tor Vergata, Università Roma Tor Vergata
city: Salerno
country: Italy
facility: Presidio Ospedaliero "A. Torto
city: Sassari
country: Italy
facility: Azienda Ospedaliera Universitaria di Sassari
city: Torino
country: Italy
facility: A.O. Citta' della Salute e del
city: Veneto
country: Italy
facility: Policlinico "G.B. Rossi" Verona
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Bergen
country: Norway
facility: Haukeland Sykehus
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Servicio de Hematología y
state: Canarias
city: Santander
country: Spain
facility: H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología
state: Cantabria
city: Marbella
country: Spain
facility: Hospital costa del sol
state: Málaga
city: Alzira
country: Spain
facility: H.U. Ribera de Alzira
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital del Mar,Hematologia Hemotheropia
city: Barcelona
country: Spain
facility: H. Clinic de Barcelona
city: Barcelona
country: Spain
facility: Pauc Tauli
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Instit Catalia D'Oncologia
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Girona
country: Spain
facility: Hospital Josep Trueta (ICO Girona)
city: Grenada
country: Spain
facility: Hospital Virgen de Las Nieves
city: LLobregat
country: Spain
facility: Department of Hematology, Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hopsital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario fundacion Jiminez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octobre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: H Universitario Puera de Hierro
city: Mallorca
country: Spain
facility: Hospital Son Espaces
city: Oviedo
country: Spain
facility: Hospital Universitario central de Asturias
city: Salamenca
country: Spain
facility: Univesity Hospital de Salamanca
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Sevilla
country: Spain
facility: Hopsital Nuestra Senora de Valme
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospiral Universitario de la Fe
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Kalmar
country: Sweden
facility: Länssjukhuset Kalmar
city: Lund
country: Sweden
facility: Lund University Hospital - Lasarettsgatan 23
city: Stockholm
country: Sweden
facility: Karolinska University Hopsital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: Kent
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - Foresterhill Road
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: East Kilbride
country: United Kingdom
facility: Monkton, Wishaw and Hairmyres Hospitals
city: Essex
country: United Kingdom
facility: Broomfield Hospital - Mid-Essex Hospitals NHS Trust
city: Essex
country: United Kingdom
facility: Basildon and Thurrock Hospitals
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Lincoln
country: United Kingdom
facility: Lincoln county Hospital
city: Liverpool
country: United Kingdom
facility: Aintree Hospital - Longmoor Lane
city: Manchester
country: United Kingdom
facility: University Hospital South Manc
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
city: Oxford
country: United Kingdom
facility: Radcliffe Hospitals and University - Headley Way, Headington
city: Swindon
country: United Kingdom
facility: Great Western Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: