A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
- Registration Number
- NCT02164955
- Lead Sponsor
- Celgene
- Brief Summary
This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 775
Understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the Registry.
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.
Refusal to participate in the Registry or currently participating in the treatment phase of an interventional clinical trial.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Relapsed and Refractory Multiple Myeloma Patients IMNOVID Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
- Primary Outcome Measures
Name Time Method Determine incidence of risks as outlined in the Risk Management Plan Up to 3 years To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated multiple myeloma patients who are currently being treated with IMNOVID (pomalidomide) in a post-marketing setting.
- Secondary Outcome Measures
Name Time Method Previous Treatments Approximately 6 months To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).
Pregnancy Prevention Programme Effectiveness Up to 3 years To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry
Trial Locations
- Locations (122)
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Rue Du Parc 29, Belgium
Clinique Saint-Pierre
🇧🇪Ottignies, Belgium
Broomfield Hospital
🇬🇧Broomfield,Chelmsford, Essex, United Kingdom
Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre
🇬🇧Maidstone, Kent, United Kingdom
Odense Hospital
🇩🇰Odense, Kloevervanget 10, Denmark
Aarhus Universitetshospital
🇩🇰Midtjylland, Noerrebrogade 44, Denmark
Centre hospitalier de Jolimont
🇧🇪La Louviere, Rue Ferrer 159, Belgium
Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25
🇩🇰Vejle, Denmark
Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli'
🇮🇹Napoli, Naples, Italy
Zentrum für Innere Medizin
🇩🇪Mutlangen, Germany
Studienzentrum Onkologie Ravensburg
🇩🇪Ravensburg, Germany
Reparto Di Ematologia Dell'Azienda
🇮🇹Brescia, Lombardy, Italy
Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust
🇬🇧Huddersfield, Lindley, United Kingdom
Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust
🇬🇧Colchester, Turner Road, United Kingdom
Klinikum Enroll von Bergmann
🇩🇪Potsdam, Charlotteustr 72, Germany
Gemeinschaftspraxis Fur Hamatologie Und Onkologie
🇩🇪Koln-Kalk, Buchforststr 14, Germany
Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen
🇩🇪Muenchen, Marchioninistr. 15, Germany
Hospital Arnau De Vilanova De Valencia
🇪🇸Valencia, Calle San Clemente, 12, Spain
Ziekenhuis Netwerk Antwerpen- Campus Middelheim
🇧🇪Antwerpen, Lindendreef 1, Belgium
Az Nikolaas
🇧🇪Sint-Niklaas, Lodewijk De Meesterstraat 5, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Avenue Hippocrate 10, Belgium
Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph
🇧🇪Arlon, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
CHC
🇧🇪Liege, Belgium
Klinikum Traunstein
🇩🇪Traunstein, Cuno-Niggl-Strate 3, Germany
Studienzentrum Haematologie/Onkologie/Diabetologie
🇩🇪Aschaffenburg, Elisenstr.26, Germany
Universitaetsklinikum Essen, Westdeutsches Tumorzentrum
🇩🇪Essen, Hufelandstraße 55, Germany
UBAG MVZ Mitte/ MVZ Delitzsch GmbH
🇩🇪Delitzsch, Ludwig- Jahn- Str. 4, Germany
Diakonie-Klinikum Schwabisch Hall
🇩🇪Schwabisch Hall, Innere Medizin 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
Evangelisches Krankenhaus Hamm GgmbH
🇩🇪Hamm, Werler Str. 110, Germany
Malteser Krankenhaus St. Franziskus Hospital
🇩🇪Flensburg, Waldstr. 17, Germany
Dr. Reiner Weinberg, Md, Office Of
🇩🇪Aachen, Weberstr. 8, Germany
Carl-Thiem-Klinikum Cottbus
🇩🇪Cottbus, Germany
Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3
🇩🇪Frankfurt, Germany
Uberortliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Dres. Verpoort, Wierecky & Zeller
🇩🇪Hamburg, Germany
Praxis Dr Schwarzer
🇩🇪Leipzig, Germany
Stauferklinikum Schwaebisch Gmuend
🇩🇪Mutlangen, 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
Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Florence, Italy
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Veneto, Italy
Azienda Ospedaliera Univarsitaria Consorziale Policlinico di Bari
🇮🇹Bari, Italy
Institute of Hematology- Sapienza University -Rome, Italy
🇮🇹Roma, Rome, 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
A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
🇮🇹Catania, Italy
Azienda Ospedaliera Universitaria "San Martino"
🇮🇹Genova, Italy
Centro Trapianti Midollo Osseo Ospedale Bnaghi
🇮🇹Cagliari, Italy
Ematologia, Policlinico di Milano
🇮🇹Milano, Italy
Ospedale San Raffaele Srl
🇮🇹Milan, Italy
Casa di Cura La Maddalena
🇮🇹Palermo, Italy
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
AOUP, Santa Chiara Hospital
🇮🇹Pisa, Italy
A.O. Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
🇮🇹Salerno, Italy
Policlinico S.Eugenio
🇮🇹Roma, 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
HF Alesund Hospital
🇳🇴Alesund, Norway
Universita Degli Studi Policlinico
🇮🇹Udine, Italy
Helse Bergen HF Haukeland University Hospital
🇳🇴Bergen, Norway
Vestre Viken/Baerums sjukhus
🇳🇴Drammen, Norway
Fredrikstad Hospital
🇳🇴Fredrikstad, Norway
Nuestra Senora de Valme
🇪🇸Sevilla, Avda. Bellavista, S/N, Spain
University Hospital Reina Sofia
🇪🇸Cordoba, Avda Menendez Pidal S/n, Spain
General San Pedro de Alcantara
🇪🇸Caceres, Avenida Pablo Naranjo Porras, Spain
Hospital Puerta del Mar
🇪🇸Cadiz, Avenida Ana De Viya, 21, Spain
General de Jane
🇪🇸Jaen, Avenida Ejercito Espanol 10, 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 de Elche
🇪🇸Elche, CAMI DE L´almassera 11, Spain
Hospital General Universitario Santa Lucia
🇪🇸Cartagena (murcia), Calle Mezquita, Spain
Hospital Universitario Nuestra Senora De Candelaria
🇪🇸Tenerife, Carretera Del Rosario, 145, Spain
Hospital de Cabuenes
🇪🇸Gijon, Camino De Los Prados, Spain
University Hospital UMEA
🇸🇪Umea, Sweden
Hospital Fundacion Son Llatzer
🇪🇸Palma de Mallorca, Ctra. Manacor, Km. 4, Spain
Hospital universitario de Alava
🇪🇸Alava, Jose Achotegui, Spain
Ctra. Orihuela - Almoradi
🇪🇸Orihuela (alicante), S/N San Bartolome, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Servicio De Oncologia, Spain
IC0 Duran y Reynalds
🇪🇸Barcelona, L´Hospitalet De Llobregat, Spain
Sunderby Hospital
🇸🇪Lulea, Sweden
Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
🇬🇧Doncaster, Armthorpe Road, United Kingdom
Pinderfields Hospital-Mid Yorkshire Nhs Trust
🇬🇧Wakefield, Aberford Road, United Kingdom
County Durham and Darlington NHS foundation Trust
🇬🇧County Durham, Darlington Memorial Hospital, 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
Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust
🇬🇧Blackpool, Lancashire, 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
University Hospital of Wales
🇬🇧Cardiff, Vale Of Glamorgan, United Kingdom
City Hospitals Sunderland NHS Trust Recruiting
🇬🇧Sunderland, Sunderland Royal Hospital, United Kingdom
Northwick Park Hospital - North West London Hospitals Nhs Trust
🇬🇧Harrow, Watford Road, United Kingdom
Northhampton Gerneral Hospital
🇬🇧Northampton, Cliftonville, United Kingdom
St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust
🇬🇧Carshalton, Wrythe Lane, United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
🇬🇧Worcester, Worcestershire, United Kingdom
Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust
🇬🇧Swansea, West Glamorgan, United Kingdom
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
🇬🇧Bath, United Kingdom
The Royal Liverpool and Broadgreen -University Hospitals NHS
🇬🇧Liverpool, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, 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
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Wexham Park Hospital
🇬🇧Slough, United Kingdom
Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital
🇬🇧Tyne And Wear, United Kingdom
Charite der Humboldt-Universität
🇩🇪Berlin, Chariteplatz 1, Germany
Stadtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Medizinische Klinik III, Germany
GP Dres. Verpoort
🇩🇪Hamburg, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Hospital Costa Del Sol
🇪🇸Marbella, Autovia A-7, Km 187, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Avenida De Roma S/n, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Passeig De La Vall D'Hebron 119-129, Spain