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Myelodysplastic SyndromePASS MDS del5qNCT02279654

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

An observational study of Myelodysplastic Syndrome, run by Celgene at 148 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndrome
What is being tested?
Lenalidomide
How many people
389 participants
Where
148 sitesin 12 countries
Study dates
17 Dec 2014to 29 Mar 2022
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

148 sites in 12 countries.

148 sites in 12 countries

Spain29 sites

  • H.U. Ribera de Alzira

    Alzira, 46600

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital del Mar,Hematologia Hemotheropia

    Barcelona, 08003

  • H. Clinic de Barcelona

    Barcelona, 08036

  • Pauc Tauli

    Barcelona, 08208

  • Hospital Vall d'Hebron

    Barcelona, 08835

  • Instit Catalia D'Oncologia

    Barcelona, 08916

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Josep Trueta (ICO Girona)

    Girona, 17007

  • Hospital Virgen de Las Nieves

    Granada, 18014

  • Hospital Universitario de Gran Canaria Servicio de Hematología y

    Las Palmas de Gran Canaria, Canary Islands, 35010

  • Department of Hematology, Hospital Duran i Reynals

    LLobregat, 08908

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hopsital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario fundacion Jiminez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octobre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • H Universitario Puera de Hierro

    Madrid, 28222

  • Hospital Son Espaces

    Mallorca, 07120

  • Hospital costa del sol

    Marbella, Málaga, 29603

  • Hospital Universitario central de Asturias

    Oviedo, 33011

  • Univesity Hospital de Salamanca

    Salamenca, 37007

  • H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología

    Santander, Cantabria, 39008

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen Macarena

    Seville, 41009

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hopsital Nuestra Senora de Valme

    Seville, 41014

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospiral Universitario de la Fe

    Valencia, 46026

Other trials in Spain

Germany26 sites

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

  • Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center

    Chemnitz, 09113

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 01307

  • Universitätsklinik Carl-Gustav

    Dresden, 01307

  • HELIOS St. Johannes Klinik

    Duisburg, 47166

  • Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

    Düsseldorf, 40225

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

  • St Antonius Hospital (SAH)

    Eschweiler, 52249

  • Kreiskrankenhaus St. Elisabeth - Von Werth-Str.

    Grevenbroich, 41515

  • Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort

    Hamburg, 20095

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068

  • InVO Institut fur Versorgungsforschung

    Koblenz, 56068

  • Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach

    Lebach, 66822

  • Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig

    Leipzig, 04103

  • III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim

    Mannheim, 68167

  • Gesellschaft für Medizinische

    Mönchengladbach, 41239

  • MLL Münchner Leukämielabor GmbH

    München, 81377

  • III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48149

  • Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen

    Tübingen, 72076

  • Klinik für Innere Medizin III

    Ulm, 89081

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Westerstede, 26655

  • Rems-Murr-Klinikum Winnenden

    Winnenden, 71364

  • Universitätsklinikum Würzburg

    Würzburg, 97080

  • ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Italy22 sites

  • AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

    Ancona, 60020

  • U.O Ematologia con Trapianto

    Bari, 70124

  • Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS

    Bergamo, 1 24127

  • Policlinico S.Orsola Malpighi, AOU di Bologna

    Bologna, 40138

  • AO Spedali Civili di Brescia

    Brescia, 25123

  • Ospedale di Castelfranco Venet

    Castelfranco Veneto, Treviso, 31033

  • Policlinico di Catania

    Catania, 95124

  • AOU Careggi

    Florence, 50134

  • U.O .C di Oncoematologia

    Mirano, 76 30035

  • Ospedale S. Luigi Gonzaga

    Orbassano, 10043

  • Azienda ospedaliero-universita

    Parma, 43126

  • Azienda Ospedaliera di Perugia

    Perugia, 106100

  • Ospedale Civile Santo Spirito

    Pescara, 65124

  • Arcispedale S.Maria Nuova

    Reggio Emilia, 42123

  • U.O Ematologia Azienda Ospedaliera

    Regio Calabria, 89100

  • Irccs Crob

    Rionero in Vulture, Potenza, 85028

  • Univesita La Sapienza

    Roma, 00161

  • AOU Policlinico Tor Vergata, Università Roma Tor Vergata

    Roma, 81 00133

  • Presidio Ospedaliero "A. Torto

    Salerno, 84016

  • Azienda Ospedaliera Universitaria di Sassari

    Sassari, 07100

  • A.O. Citta' della Salute e del

    Torino, 10126

  • Policlinico "G.B. Rossi" Verona

    Veneto, 37100

Other trials in Italy

France17 sites

  • CHU Hôtel Dieu

    Angers, 49933

  • Centre Hospitalier D'Avignon - Hopital Henri Duffaut

    Avignon, 84000

  • CH Chalon/Saone William Morey

    Chalon-sur-Saône, 71100

  • CHU Grenoble

    La Tronche, 38700

  • CHRU De Lille - Hôpital Claude - Rue Michel Polonovski

    Lille, 59037

  • Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt

    Limoges, 87042

  • Institut Paoli Calmettes

    Marseille, Bouches-du-Rhône, 13273

  • CHU Hôtel Dieu

    Nantes, Loire-Atlantique, 44093

  • CHU Hôtel Dieu - Place A Ricordeau

    Nantes, 44000

  • Hopital de L'archet I

    Nice, Alpes-Maritimes, 6202

  • Hôpital St Louis

    Paris, 75475

  • CHU Haut-Lévêque

    Pessac, Gironde, 33604

  • Centre Hospitalier Lyon-SUD [U

    Pierre-Bénite, 69310

  • Hopital de Hautepierre CHRU de Strasbourg

    Strasbourg, 67091

  • Hopital Purpan-Place du Dr. Baylac

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37000

  • CHU Nancy Brabois Adultes - 58 Allee dy morvan

    Vandœuvre-lès-Nancy, 54500

Other trials in France

United Kingdom14 sites

  • Aberdeen Royal Infirmary - Foresterhill Road

    Aberdeen, AB25 2ZN

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Pilgrim Hospital

    Boston, PE21 9QS

  • Monkton, Wishaw and Hairmyres Hospitals

    East Kilbride, G75 8RG

  • Broomfield Hospital - Mid-Essex Hospitals NHS Trust

    Essex, CM1 7ET

  • Basildon and Thurrock Hospitals

    Essex, SS16 5NL

  • Northwick Park Hospital

    Harrow, HA1 3UJ

  • Lincoln county Hospital

    Lincoln, LN2 5QY

  • Aintree Hospital - Longmoor Lane

    Liverpool, L9 7AL

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

  • University Hospital South Manc

    Manchester, M23 9LT

  • Royal Oldham Hospital

    Oldham, OL1 2JH

  • Radcliffe Hospitals and University - Headley Way, Headington

    Oxford, OX3 9DU

  • Great Western Hospital

    Swindon, SN3 6BB

Other trials in United Kingdom

United States13 sites

  • Local Institution - 0001

    Centre City, New Jersey, ZIP CODE

  • Local Institution - 0002

    Centre City, New Jersey, ZIP CODE

  • Local Institution - Belgium

    No City Provided, New Jersey, 00000

  • Local Institution - Denmark

    No City Provided, New Jersey, 00000

  • Local Institution - France

    No City Provided, New Jersey, 00000

  • Local Institution - Germany

    No City Provided, New Jersey, 00000

  • Local Institution - Greece

    No City Provided, New Jersey, 00000

  • Local Institution - Italy

    No City Provided, New Jersey, 00000

  • Local Institution - Luxembourg

    No City Provided, New Jersey, 00000

  • Local Institution - Norway

    No City Provided, New Jersey, 00000

  • Local Institution - Spain

    No City Provided, New Jersey, 00000

  • Local Institution - Sweden

    No City Provided, New Jersey, 00000

  • Local Institution - UK

    No City Provided, New Jersey, 00000

Other trials in United States

Greece9 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, GR-68100

  • General Hospital of Athens - LAIKO

    Athens, 11527

  • University General Hospital

    Athens, 12461

  • Georgios Gennimatos General Hospital

    Athens, GR 11527

  • University Hospital Of Herakli

    Herakleion - Crete, 71110

  • University General Hospital of Ioannina

    Ioannina, 45500

  • University General Hospital of Larissa

    Larissa, 4110

  • University General Hospital of Patras

    Pátrai, 26504

  • G. Papanikolaou General Hospital

    Thessaloniki, 57010

Other trials in Greece

Belgium7 sites

  • AZ Klina

    Brasschaat, B -2930

  • AZ Sint Jan

    Bruges, B-8000

  • GHdCharleroi

    Charleroi, B-6000

  • Jessa Ziekenhuis

    Hasselt, B-35000

  • CHR Citadelle

    Liège, 4000

  • CHU Vésale

    Montigny-le-Tilleul, B-6110

  • Clinique Saint-Pierre Ottignie

    Ottignies, 01340

Other trials in Belgium

Denmark5 sites

  • Aalborg Sygehus, Dept of Hematology

    Aalborg, DK-9000

  • Århus University Hospital

    Aarhus, DK-8000

  • Herlev Hospital

    Herlev, 2730

  • Odense University Hospital

    Odense, 5000

  • Rokslide Hospital

    Roskilde, 4000

Other trials in Denmark

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Länssjukhuset Kalmar

    Kalmar, 391 85

  • Lund University Hospital - Lasarettsgatan 23

    Lund, 22185

  • Karolinska University Hopsital

    Stockholm, 141 86

Other trials in Sweden

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg, 01210

Other trials in Luxembourg

Norway1 site

  • Haukeland Sykehus

    Bergen, N-5021

Other trials in Norway

About this study

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

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.

Being tested
Lenalidomide
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
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid, CC-5013

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

Study groups in NCT02279654
Study groupRoleWhat they receive
Lenalidomide PopulationPatients 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
Receives: Drug: Lenalidomide
Background PopulationAll 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
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years

  2. 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

    Measured: Up to 3 years

Secondary outcomes (4)

  1. 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

    Measured: Up to 3 years

  2. 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

    Measured: Up to 3 years

  3. 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

    Measured: Up to 3 years

  4. 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

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2014 (estimated)
  2. Study start17 Dec 2014
  3. Primary completion29 Mar 2022
  4. Study completion29 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
389 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02279654
Sponsor's protocol ID
CC-5013-MDS-010
Acronym
PASS MDS del5q
Status last verified
Aug 2022
First submitted
21 Oct 2014
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic Syndrome, run by Celgene at 148 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in Spain, Germany, Italy, France, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02279654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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