A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
NCT ID: NCT02164955
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
775 participants
OBSERVATIONAL
2014-06-26
2022-10-10
Brief Summary
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The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Relapsed and Refractory Multiple Myeloma Patients
Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
IMNOVID
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Interventions
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IMNOVID
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment.
Exclusion Criteria
Pregnancy.
Women of childbearing potential, unless all the conditions of the pregnancy prevention program are met.
Male patients unable to follow or comply with the required contraceptive measures.
Hypersensitivity to the active substance or to any of the excipients.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Cliniques Universitaires Saint Luc
Brussels, Avenue Hippocrate 10, Belgium
Ziekenhuis Netwerk Antwerpen- Campus Middelheim
Antwerp, Lindendreef 1, Belgium
Az Nikolaas
Sint-Niklaas, Lodewijk de Meesterstraat 5, Belgium
Centre Hospitalier Peltzer-La Tourelle
Verviers, Rue Du Parc 29, Belgium
Centre hospitalier de Jolimont
La Louvière, Rue Ferrer 159, Belgium
Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph
Arlon, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
CHC
Liège, , Belgium
Clinique Saint-Pierre
Ottignies, , Belgium
Odense Hospital
Odense, Kloevervanget 10, Denmark
Aarhus Universitetshospital
Karup, Noerrebrogade 44, Denmark
Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25
Vejle, , Denmark
Gemeinschaftspraxis Fur Hamatologie Und Onkologie
Koln-Kalk, Buchforststr 14, Germany
Charite der Humboldt-Universität
Berlin, Chariteplatz 1, Germany
Klinikum Enroll von Bergmann
Potsdam, Charlotteustr 72, Germany
Klinikum Traunstein
Traunstein, Cuno-Niggl-Strate 3, Germany
Studienzentrum Haematologie/Onkologie/Diabetologie
Aschaffenburg, Elisenstr.26, Germany
Universitaetsklinikum Essen, Westdeutsches Tumorzentrum
Essen, Hufelandstraße 55, Germany
Diakonie-Klinikum Schwabisch Hall
Schwäbisch Hall, Innere Medizin III, Germany
UBAG MVZ Mitte/ MVZ Delitzsch GmbH
Delitzsch, Ludwig- Jahn- Str. 4, Germany
Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen
München, Marchioninistr. 15, Germany
Stadtisches Klinikum Karlsruhe
Karlsruhe, Medizinische Klinik III, Germany
Schwerpunktpraxis und Tagesklinik fur Hamatologie und Onkologie
Kronach, Niederbronner Stabe 2, Germany
Klinikum Lippe-Lemgo
Minden, Rintelner Strae 85, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Schwanebecker Chaussee 50, Germany
Malteser Krankenhaus St. Franziskus Hospital
Flensburg, Waldstr. 17, Germany
Dr. Reiner Weinberg, Md, Office Of
Aachen, Weberstr. 8, Germany
Evangelisches Krankenhaus Hamm GgmbH
Hamm, Werler Str. 110, Germany
Carl-Thiem-Klinikum Cottbus
Cottbus, , Germany
Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3
Frankfurt, , Germany
GP Dres. Verpoort
Hamburg, , Germany
Uberortliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Dres. Verpoort, Wierecky & Zeller
Hamburg, , Germany
Praxis Dr Schwarzer
Leipzig, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Klinik für Hämatologie, Onkologie und Palliativmedizin Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
Minden, , Germany
Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers
Moers, , Germany
Stauferklinikum Schwaebisch Gmuend
Mutlangen, , Germany
Zentrum für Innere Medizin
Mutlangen, , Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, , Germany
Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Florence, Italy
Reparto Di Ematologia Dell'Azienda
Brescia, Lombardy, Italy
Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli'
Napoli, Naples, Italy
Institute of Hematology- Sapienza University -Rome, Italy
Roma, Rome, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, Veneto, Italy
Azienda Ospedaliera Univarsitaria Consorziale Policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo, , Italy
AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Brescia, , Italy
Centro Trapianti Midollo Osseo Ospedale Bnaghi
Cagliari, , Italy
A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
Catania, , Italy
Azienda Ospedaliera Universitaria "San Martino"
Genova, , Italy
Ospedale San Raffaele Srl
Milan, , Italy
Ematologia, Policlinico di Milano
Milan, , Italy
Casa di Cura La Maddalena
Palermo, , Italy
AOUP, Santa Chiara Hospital
Pisa, , Italy
A.O. Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Policlinico S.Eugenio
Roma, , Italy
A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
Salerno, , Italy
AOU Ospedali Riuniti Umbertio I
Torrette Di Ancona, , Italy
U.O Ematologia Az. ULSS9 di Treviso
Treviso, , Italy
Unita di Oncologia Polmonare A.o. San
Turin, , Italy
Universita Degli Studi Policlinico
Udine, , Italy
HF Alesund Hospital
Ålesund, , Norway
Helse Bergen HF Haukeland University Hospital
Bergen, , Norway
Vestre Viken/Baerums sjukhus
Drammen, , Norway
Fredrikstad Hospital
Fredrikstad, , Norway
Hospital Costa Del Sol
Marbella, Autovia A-7, Km 187, Spain
University Hospital Reina Sofia
Córdoba, Avda Menendez Pidal S/n, Spain
Nuestra Senora de Valme
Seville, Avda. Bellavista, S/N, Spain
Hospital Puerta del Mar
Cadiz, Avenida Ana de Viya, 21, Spain
Hospital Universitario Central de Asturias
Oviedo, Avenida de Roma S/n, Spain
General de Jane
Jaén, Avenida Ejercito Espanol 10, Spain
General San Pedro de Alcantara
Cáceres, Avenida Pablo Naranjo Porras, Spain
Hospital Clinico Universitario De Valladolid
Valladolid, Avenida Ramon Y Cajal 3, Spain
Hospital Universitario de La Princesa
Madrid, C/ Diego de León 62, 3a Planta, Spain
Hospital Xeral de Lugo
Lugo, C/ Doctor Severo Ochoa S/N, Spain
Hospital Son Dureta
Palma de Mallorca, Calle Andrea Doria 55, Spain
Hospital General Universitario Santa Lucia
Cartagena (murcia), Calle Mezquita, Spain
Hospital Arnau De Vilanova De Valencia
Valencia, Calle San Clemente, 12, Spain
Hospital General Universitario de Elche
Elche, CAMI de L´almassera 11, Spain
Hospital de Cabuenes
Gijón, Camino de Los Prados, Spain
Hospital Universitario Nuestra Senora De Candelaria
Santa Cruz de Tenerife, Carretera Del Rosario, 145, Spain
Hospital Fundacion Son Llatzer
Palma de Mallorca, Ctra. Manacor, Km. 4, Spain
Hospital universitario de Alava
Alava, Jose Achotegui, Spain
IC0 Duran y Reynalds
Barcelona, L´Hospitalet de Llobregat, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Passeig de La Vall D'Hebron 119-129, Spain
Ctra. Orihuela - Almoradi
Orihuela (alicante), S/N San Bartolome, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Servicio de Oncologia, Spain
Sunderby Hospital
Luleå, , Sweden
University Hospital UMEA
Umeå, , Sweden
Pinderfields Hospital-Mid Yorkshire Nhs Trust
Wakefield, Aberford Road, United Kingdom
Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
Doncaster, Armthorpe Road, United Kingdom
Northhampton Gerneral Hospital
Northampton, Cliftonville, United Kingdom
County Durham and Darlington NHS foundation Trust
County Durham, Darlington Memorial Hospital, United Kingdom
Broomfield Hospital
Broomfield,Chelmsford, Essex, United Kingdom
Aberdeen Royal Infirmary - Nhs Grampian
Aberdeen, Foresterhill Road, United Kingdom
The Newcastle Upon Tyne Hospitals Nhs Foundation
Newcastle upon Tyne, Freeman Hospital, United Kingdom
Lincoln County Hospital - United Lincolnshire Hospitals Nhs Trust
Lincoln, Greetwell Road, United Kingdom
Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre
Maidstone, Kent, United Kingdom
Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust
Blackpool, Lancashire, United Kingdom
Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust
Huddersfield, Lindley, United Kingdom
Worthing Hospital - Western Sussex Hospitals Nhs Trust
Worthing, Lyndhurst Road, United Kingdom
Monklands Hospital Trust: Nhs Lanarkshire - Acute Services Division
Airdrie, Monkscourt Avenue, United Kingdom
Southmead Hospital - North Bristol Nhs Trust Recruiting
Bristol, Southmead Road, United Kingdom
City Hospitals Sunderland NHS Trust Recruiting
Sunderland, Sunderland Royal Hospital, United Kingdom
Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust
Colchester, Turner Road, United Kingdom
University Hospital of Wales
Cardiff, Vale Of Glamorgan, United Kingdom
Northwick Park Hospital - North West London Hospitals Nhs Trust
Harrow, Watford Road, United Kingdom
Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust
Swansea, West Glamorgan, United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, Worcestershire, United Kingdom
St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust
Carshalton, Wrythe Lane, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, , United Kingdom
Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
Bath, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
The Royal Liverpool and Broadgreen -University Hospitals NHS
Liverpool, , United Kingdom
Specialist Cancer Pharmacist-Oxford Cancer Centre & Cancer Research UK-Churchill Hospital-Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Royal Berkshire hospital
Reading, , United Kingdom
Wexham Park Hospital
Slough, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital
Tyne and Wear, , United Kingdom
Countries
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References
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Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.
Schafer PH, Ye Y, Wu L, Kosek J, Ringheim G, Yang Z, Liu L, Thomas M, Palmisano M, Chopra R. Cereblon modulator iberdomide induces degradation of the transcription factors Ikaros and Aiolos: immunomodulation in healthy volunteers and relevance to systemic lupus erythematosus. Ann Rheum Dis. 2018 Oct;77(10):1516-1523. doi: 10.1136/annrheumdis-2017-212916. Epub 2018 Jun 26.
Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.
Related Links
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Expanded Access for CC-4047
Other Identifiers
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CC-4047-MM-015
Identifier Type: -
Identifier Source: org_study_id
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