Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

Myelodysplastic Syndrome Clinical Trial

— PASS MDS del5q  

Official title:

A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279654
• Other study ID #: CC-5013-MDS-010
• Status: Completed
• Start date: December 17, 2014
• Est. completion date: March 29, 2022

Study information

• Verified date: August 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Lenalidomide
Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Greece,  Italy,  Luxembourg,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 3 years
Primary	Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide	Number of MDS participants who survive	Up to 3 years
Secondary	Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide	Number of MDS participants who survive who have never been treated with Lenalidomide	Up to 3 years
Secondary	Adverse Events	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	Up to 3 years
Secondary	Evaluate risk factors associated with progression of AML	Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide	Up to 3 years
Secondary	Clinical practice	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	Up to 3 years