Multiple Myeloma Clinical Trial
Official title:
A Non-interventional Post Authorisation Registry of Patients Treated With Pomalidomide for Relapsed and Refractory Multiple Myeloma Who Have Received at Least Two Prior Treatment Regimens, Including Both Lenalidomide and Bortezomib, and Have Demonstrated Disease Progression on the Last Therapy
| Verified date | October 2022 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 775 |
| Est. completion date | October 10, 2022 |
| Est. primary completion date | October 10, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ziekenhuis Netwerk Antwerpen- Campus Middelheim | Antwerpen | Lindendreef 1 |
| Belgium | Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph | Arlon | |
| Belgium | Cliniques Universitaires Saint Luc | Bruxelles | Avenue Hippocrate 10 |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Centre hospitalier de Jolimont | La Louviere | Rue Ferrer 159 |
| Belgium | CHC | Liege | |
| Belgium | Clinique Saint-Pierre | Ottignies | |
| Belgium | Az Nikolaas | Sint-Niklaas | Lodewijk De Meesterstraat 5 |
| Belgium | Centre Hospitalier Peltzer-La Tourelle | Verviers | Rue Du Parc 29 |
| Denmark | Aarhus Universitetshospital | Midtjylland | Noerrebrogade 44 |
| Denmark | Odense Hospital | Odense | Kloevervanget 10 |
| Denmark | Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25 | Vejle | |
| Germany | Dr. Reiner Weinberg, Md, Office Of | Aachen | Weberstr. 8 |
| Germany | Studienzentrum Haematologie/Onkologie/Diabetologie | Aschaffenburg | Elisenstr.26 |
| Germany | Charite der Humboldt-Universität | Berlin | Chariteplatz 1 |
| Germany | HELIOS Klinikum Berlin-Buch | Berlin | Schwanebecker Chaussee 50 |
| Germany | Carl-Thiem-Klinikum Cottbus | Cottbus | |
| Germany | UBAG MVZ Mitte/ MVZ Delitzsch GmbH | Delitzsch | Ludwig- Jahn- Str. 4 |
| Germany | Universitaetsklinikum Essen, Westdeutsches Tumorzentrum | Essen | Hufelandstraße 55 |
| Germany | Malteser Krankenhaus St. Franziskus Hospital | Flensburg | Waldstr. 17 |
| 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 | Evangelisches Krankenhaus Hamm GgmbH | Hamm | Werler Str. 110 |
| Germany | Stadtisches Klinikum Karlsruhe | Karlsruhe | Medizinische Klinik III |
| Germany | Gemeinschaftspraxis Fur Hamatologie Und Onkologie | Koln-Kalk | Buchforststr 14 |
| Germany | Schwerpunktpraxis und Tagesklinik fur Hamatologie und Onkologie | Kronach | Niederbronner Stabe 2 |
| 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 | Klinikum Lippe-Lemgo | Minden | Rintelner Strae 85 |
| Germany | Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers | Moers | |
| Germany | Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen | Muenchen | Marchioninistr. 15 |
| Germany | Stauferklinikum Schwaebisch Gmuend | Mutlangen | |
| Germany | Zentrum für Innere Medizin | Mutlangen | |
| Germany | Klinikum Enroll von Bergmann | Potsdam | Charlotteustr 72 |
| Germany | Studienzentrum Onkologie Ravensburg | Ravensburg | |
| Germany | Diakonie-Klinikum Schwabisch Hall | Schwabisch Hall | Innere Medizin III |
| Germany | Klinikum Traunstein | Traunstein | Cuno-Niggl-Strate 3 |
| 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 | Reparto Di Ematologia Dell'Azienda | Brescia | Lombardy |
| Italy | Centro Trapianti Midollo Osseo Ospedale Bnaghi | Cagliari | |
| Italy | A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto | Catania | |
| Italy | AOUC Azienda Ospedaliero-Universitaria Careggi | Firenze | Florence |
| Italy | Azienda Ospedaliera Universitaria "San Martino" | Genova | |
| Italy | Ospedale San Raffaele Srl | Milan | |
| Italy | Ematologia, Policlinico di Milano | Milano | |
| Italy | Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli' | Napoli | Naples |
| Italy | Azienda Ospedaliera Universitaria di Padova | Padova | Veneto |
| 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 | Institute of Hematology- Sapienza University -Rome, Italy | Roma | Rome |
| Italy | Policlinico S.Eugenio | Roma | |
| Italy | A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC | Salerno | |
| Italy | Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | FG |
| 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 | |
| Norway | HF Alesund Hospital | Alesund | |
| Norway | Helse Bergen HF Haukeland University Hospital | Bergen | |
| Norway | Vestre Viken/Baerums sjukhus | Drammen | |
| Norway | Fredrikstad Hospital | Fredrikstad | |
| Spain | Hospital universitario de Alava | Alava | Jose Achotegui |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | Passeig De La Vall D'Hebron 119-129 |
| Spain | IC0 Duran y Reynalds | Barcelona | L´Hospitalet De Llobregat |
| Spain | General San Pedro de Alcantara | Caceres | Avenida Pablo Naranjo Porras |
| Spain | Hospital Puerta del Mar | Cadiz | Avenida Ana De Viya, 21 |
| Spain | Hospital General Universitario Santa Lucia | Cartagena (murcia) | Calle Mezquita |
| Spain | University Hospital Reina Sofia | Cordoba | Avda Menendez Pidal S/n |
| Spain | Hospital General Universitario de Elche | Elche | CAMI DE L´almassera 11 |
| Spain | Hospital de Cabuenes | Gijon | Camino De Los Prados |
| Spain | General de Jane | Jaen | Avenida Ejercito Espanol 10 |
| Spain | Hospital Xeral de Lugo | Lugo | C/ Doctor Severo Ochoa S/N |
| Spain | Hospital Universitario de La Princesa | Madrid | C/ Diego De León 62, 3a Planta |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | Servicio De Oncologia |
| Spain | Hospital Costa Del Sol | Marbella | Autovia A-7, Km 187 |
| Spain | Ctra. Orihuela - Almoradi | Orihuela (alicante) | S/N San Bartolome |
| Spain | Hospital Universitario Central de Asturias | Oviedo | Avenida De Roma S/n |
| Spain | Hospital Fundacion Son Llatzer | Palma de Mallorca | Ctra. Manacor, Km. 4 |
| Spain | Hospital Son Dureta | Palma De Mallorca | Calle Andrea Doria 55 |
| Spain | Nuestra Senora de Valme | Sevilla | Avda. Bellavista, S/N |
| Spain | Hospital Universitario Nuestra Senora De Candelaria | Tenerife | Carretera Del Rosario, 145 |
| Spain | Hospital Arnau De Vilanova De Valencia | Valencia | Calle San Clemente, 12 |
| Spain | Hospital Clinico Universitario De Valladolid | Valladolid | Avenida Ramon Y Cajal 3 |
| Sweden | Sunderby Hospital | Lulea | |
| Sweden | University Hospital UMEA | Umea | |
| United Kingdom | Aberdeen Royal Infirmary - Nhs Grampian | Aberdeen | Foresterhill Road |
| United Kingdom | Monklands Hospital Trust: Nhs Lanarkshire - Acute Services Division | Airdrie | Monkscourt Avenue |
| United Kingdom | Basingstoke and North Hampshire Hospital | Basingstoke | |
| United Kingdom | Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust | Bath | |
| United Kingdom | Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust | Blackpool | Lancashire |
| United Kingdom | Southmead Hospital - North Bristol Nhs Trust Recruiting | Bristol | Southmead Road |
| United Kingdom | Broomfield Hospital | Broomfield,Chelmsford | Essex |
| United Kingdom | University Hospital of Wales | Cardiff | Vale Of Glamorgan |
| United Kingdom | St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust | Carshalton | Wrythe Lane |
| United Kingdom | Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust | Colchester | Turner Road |
| United Kingdom | County Durham and Darlington NHS foundation Trust | County Durham | Darlington Memorial Hospital |
| United Kingdom | Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust | Doncaster | Armthorpe Road |
| United Kingdom | Dorset County Hospital | Dorchester | |
| United Kingdom | Northwick Park Hospital - North West London Hospitals Nhs Trust | Harrow | Watford Road |
| United Kingdom | Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust | Huddersfield | Lindley |
| United Kingdom | Lincoln County Hospital - United Lincolnshire Hospitals Nhs Trust | Lincoln | Greetwell Road |
| United Kingdom | The Royal Liverpool and Broadgreen -University Hospitals NHS | Liverpool | |
| United Kingdom | Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre | Maidstone | Kent |
| United Kingdom | The Newcastle Upon Tyne Hospitals Nhs Foundation | Newcastle Upon Tyne | Freeman Hospital |
| United Kingdom | Northhampton Gerneral Hospital | Northampton | Cliftonville |
| 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 | City Hospitals Sunderland NHS Trust Recruiting | Sunderland | Sunderland Royal Hospital |
| United Kingdom | Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust | Swansea | West Glamorgan |
| United Kingdom | Royal Cornwall Hospital | Truro | |
| United Kingdom | Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital | Tyne And Wear | |
| United Kingdom | Pinderfields Hospital-Mid Yorkshire Nhs Trust | Wakefield | Aberford Road |
| United Kingdom | Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital | Worcester | Worcestershire |
| United Kingdom | Worthing Hospital - Western Sussex Hospitals Nhs Trust | Worthing | Lyndhurst Road |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
Belgium, Denmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom,
Dinner S, Dunn TJ, Price E, Coutré 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. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine incidence of risks as outlined in the Risk Management Plan | 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. | Up to 3 years | |
| Secondary | Pregnancy Prevention Programme Effectiveness | To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry | Up to 3 years | |
| Secondary | Previous Treatments | To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide). | Approximately 6 months |
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