Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q) (PASS MDS del5q)

August 18, 2022 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

389

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brasschaat, Belgium, B -2930
        • AZ Klina
      • Brugge, Belgium, B-8000
        • AZ Sint Jan
      • Charleroi, Belgium, B-6000
        • GHdCharleroi
      • Hasselt, Belgium, B-35000
        • Jessa Ziekenhuis
      • Liège, Belgium, 4000
        • CHR Citadelle
      • Montigny- le- tilleul, Belgium, B-6110
        • CHU Vésale
      • Ottignies, Belgium, 01340
        • Clinique Saint-Pierre Ottignie
  • Denmark
      • Aalborg, Denmark, DK-9000
        • Aalborg Sygehus, Dept of Hematology
      • Aarhus, Denmark, DK-8000
        • Århus University Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Rokslide Hospital
  • France
      • Angers, France, 49933
        • Chu Hotel Dieu
      • Avignon, France, 84000
        • Centre Hospitalier D'Avignon - Hopital Henri Duffaut
      • Chalon Sur Saone, France, 71100
        • CH Chalon/Saone William Morey
      • La Tronche, France, 38700
        • CHU Grenoble
      • Lille, France, 59037
        • CHRU De Lille - Hôpital Claude - Rue Michel Polonovski
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt
      • Nantes, France, 44000
        • CHU Hôtel Dieu - Place A Ricordeau
      • Paris, France, 75475
        • Hopital St Louis
      • Pierre- Bénite, France, 69310
        • Centre Hospitalier Lyon-SUD [U
      • Strasbourg, France, 67091
        • Hopital de Hautepierre CHRU de Strasbourg
      • Toulouse, France, 31059
        • Hopital Purpan-Place du Dr. Baylac
      • Tours, France, 37000
        • CHU Bretonneau
      • Vandoeuvre les Nancy, France, 54500
        • CHU Nancy Brabois Adultes - 58 Allee dy morvan
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 6202
        • Hôpital de L'Archet I
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13273
        • Institut Paoli Calmettes
    • Gironde
      • Pessac, Gironde, France, 33604
        • CHU Haut-Leveque
    • Loire-Atlantique
      • Nantes cedex 01, Loire-Atlantique, France, 44093
        • Chu Hotel Dieu
  • Germany
      • Bielefeld, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld
      • Chemnitz, Germany, 09113
        • Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis Hämatologie-Onkologie
      • Dresden, Germany, 01307
        • Universitätsklinik Carl-Gustav
      • Duisburg, Germany, 47166
        • Helios St. Johannes Klinik
      • Düsseldorf, Germany, 40479
        • Marien Hospital Düsseldorf
      • Düsseldorf, Germany, 40225
        • Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
      • Eschweiler, Germany, 52249
        • St Antonius Hospital (SAH)
      • Grevenbroich, Germany, 41515
        • Kreiskrankenhaus St. Elisabeth - Von Werth-Str.
      • Hamburg, Germany, 20095
        • Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Koblenz, Germany, 56068
        • Institut Für Versorgungsforschung in Der Onkologie
      • Koblenz, Germany, 56068
        • InVo Institut für Versorgungsforschung
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach
      • Leipzig, Germany, 04103
        • Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig
      • Mannheim, Germany, 68167
        • III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim
      • Mönchengladbach, Germany, 41239
        • Gesellschaft für Medizinische
      • München, Germany, 81377
        • MLL Münchner Leukämielabor GmbH
      • München, Germany, 81675
        • III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
      • Münster, Germany, 48149
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Tübingen, Germany, 72076
        • Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen
      • Ulm, Germany, 89081
        • Klinik fur Innere Medizin III
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Winnenden, Germany, 71364
        • Rems-Murr-Klinikum Winnenden
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
      • Würzburg, Germany, 97080
        • ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg
  • Greece
      • Alexandroupolis, Greece, GR-68100
        • University Hospital of Alexandroupolis
      • Athens, Greece, 11527
        • General Hospital of Athens - Laiko
      • Athens, Greece, 12461
        • University General Hospital
      • Athens, Greece, GR 11527
        • Georgios Gennimatos General Hospital
      • Herakleion - Crete, Greece, 71110
        • University Hospital Of Herakli
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina
      • Larissa, Greece, 4110
        • University General Hospital of Larissa
      • Patras, Greece, 26504
        • University General Hospital of Patras
      • Thessaloniki, Greece, 57010
        • G. Papanikolaou General Hospital
  • Italy
      • Ancona, Italy, 60020
        • AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
      • Bari, Italy, 70124
        • U.O Ematologia con Trapianto
      • Bergamo, Italy, 1 24127
        • Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS
      • Bologna, Italy, 40138
        • Policlinico S.Orsola Malpighi, AOU di Bologna
      • Brescia, Italy, 25123
        • AO Spedali Civili di Brescia
      • Catania, Italy, 95124
        • Policlinico di Catania
      • Firenze, Italy, 50134
        • AOU Careggi
      • Mirano, Italy, 76 30035
        • U.O .C di Oncoematologia
      • Orbassano, Italy, 10043
        • Ospedale S. Luigi Gonzaga
      • Parma, Italy, 43126
        • Azienda ospedaliero-universita
      • Perugia, Italy, 106100
        • Azienda Ospedaliera di Perugia
      • Pescara, Italy, 65124
        • Ospedale Civile Santo Spirito
      • Reggio Emilia, Italy, 42123
        • Arcispedale S.Maria Nuova
      • Regio Calabria, Italy, 89100
        • U.O Ematologia Azienda Ospedaliera
      • Roma, Italy, 00161
        • Univesita La Sapienza
      • Roma, Italy, 81 00133
        • AOU Policlinico Tor Vergata, Università Roma Tor Vergata
      • Salerno, Italy, 84016
        • Presidio Ospedaliero "A. Torto
      • Sassari, Italy, 07100
        • Azienda Ospedaliera Universitaria di Sassari
      • Torino, Italy, 10126
        • A.O. Citta' della Salute e del
      • Veneto, Italy, 37100
        • Policlinico "G.B. Rossi" Verona
    • Potenza
      • Rionero in Vulture, Potenza, Italy, 85028
        • Irccs Crob
    • Treviso
      • Castelfranco Veneto, Treviso, Italy, 31033
        • Ospedale di Castelfranco Venet
  • Luxembourg
      • Luxembourg, Luxembourg, 01210
        • Centre Hospitalier de Luxembourg
  • Norway
      • Bergen, Norway, N-5021
        • Haukeland Sykehus
  • Spain
      • Alzira, Spain, 46600
        • H.U. Ribera de Alzira
      • Barakaldo, Spain, 48903
        • Hospital de Cruces
      • Barcelona, Spain, 08036
        • H. Clinic de Barcelona
      • Barcelona, Spain, 08003
        • Hospital del Mar,Hematologia Hemotheropia
      • Barcelona, Spain, 08208
        • Pauc Tauli
      • Barcelona, Spain, 08835
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08916
        • Instit Catalia D'Oncologia
      • Cordoba, Spain, 14004
        • Hospital Reina Sofía
      • Girona, Spain, 17007
        • Hospital Josep Trueta (ICO Girona)
      • Grenada, Spain, 18014
        • Hospital Virgen de las Nieves
      • LLobregat, Spain, 08908
        • Department of Hematology, Hospital Duran i Reynals
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28040
        • Hopsital Clínico San Carlos
      • Madrid, Spain, 28040
        • Hospital Universitario fundacion Jiminez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octobre
      • Madrid, Spain, 28222
        • H Universitario Puera de Hierro
      • Mallorca, Spain, 07120
        • Hospital Son Espaces
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Salamenca, Spain, 37007
        • Univesity Hospital de Salamanca
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Sevilla, Spain, 41009
        • Hospital Virgen Macarena
      • Sevilla, Spain, 41014
        • Hopsital Nuestra Senora de Valme
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46026
        • Hospiral Universitario de la Fe
    • Canarias
      • Las Palmas de Gran Canaria, Canarias, Spain, 35010
        • Hospital Universitario de Gran Canaria Servicio de Hematología y
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Hospital Costa del Sol
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Göteborg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Kalmar, Sweden, 391 85
        • Länssjukhuset Kalmar
      • Lund, Sweden, 22185
        • Lund University Hospital - Lasarettsgatan 23
      • Stockholm, Sweden, 141 86
        • Karolinska University Hopsital
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary - Foresterhill Road
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Boston, United Kingdom, PE21 9QS
        • Pilgrim Hospital
      • East Kilbride, United Kingdom, G75 8RG
        • Monkton, Wishaw and Hairmyres Hospitals
      • Essex, United Kingdom, CM1 7ET
        • Broomfield Hospital - Mid-Essex Hospitals NHS Trust
      • Essex, United Kingdom, SS16 5NL
        • Basildon and Thurrock Hospitals
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • Lincoln, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree Hospital - Longmoor Lane
      • Manchester, United Kingdom, M23 9LT
        • University Hospital South Manc
      • Oldham, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Radcliffe Hospitals and University - Headley Way, Headington
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Maidstone Hospital
  • United States
    • New Jersey
      • Centre City, New Jersey, United States, ZIP CODE
        • Local Institution - 0001
      • Centre City, New Jersey, United States, ZIP CODE
        • Local Institution - 0002
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Belgium
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Denmark
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - France
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Germany
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Greece
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Italy
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Luxembourg
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Norway
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Spain
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Sweden
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - UK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lenalidomide Population
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
Drug: Lenalidomide
Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS
Other Names:
  • CC-5013
  • Revlimid
Background Population
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
Drug: Lenalidomide
Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS
Other Names:
  • CC-5013
  • Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide
Time Frame: Up to 3 years
Number of MDS participants who survive
Up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2014

Primary Completion (Actual)

March 29, 2022

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MDS-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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