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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsed and Refractory Multiple Myeloma Patients | Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMNOVID | Drug | IMNOVID (pomalidomide) as prescribed in routine clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Previous Treatments |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc | Brussels | Avenue Hippocrate 10 | 01200 | Belgium | ||
| Ziekenhuis Netwerk Antwerpen- Campus Middelheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28504846 | Background | 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. | |
| 29945920 |
| Label | URL |
|---|---|
| Expanded Access for CC-4047 | View source |
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To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).
| Approximately 6 months |
| Antwerp |
| Lindendreef 1 |
| 02020 |
| Belgium |
| Az Nikolaas | Sint-Niklaas | Lodewijk de Meesterstraat 5 | 09100 | Belgium |
| Centre Hospitalier Peltzer-La Tourelle | Verviers | Rue Du Parc 29 | 4800 | Belgium |
| Centre hospitalier de Jolimont | La Louvière | Rue Ferrer 159 | 7100 | Belgium |
| Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph | Arlon | 6700 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| CHC | Liège | 4000 | Belgium |
| Clinique Saint-Pierre | Ottignies | 1340 | Belgium |
| Odense Hospital | Odense | Kloevervanget 10 | 05000 | Denmark |
| Aarhus Universitetshospital | Karup | Noerrebrogade 44 | 8000 | Denmark |
| Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25 | Vejle | 7100 | Denmark |
| Gemeinschaftspraxis Fur Hamatologie Und Onkologie | Koln-Kalk | Buchforststr 14 | 51103 | Germany |
| Charite der Humboldt-Universität | Berlin | Chariteplatz 1 | 10117 | Germany |
| Klinikum Enroll von Bergmann | Potsdam | Charlotteustr 72 | 14467 | Germany |
| Klinikum Traunstein | Traunstein | Cuno-Niggl-Strate 3 | 83278 | Germany |
| Studienzentrum Haematologie/Onkologie/Diabetologie | Aschaffenburg | Elisenstr.26 | 63877 | Germany |
| Universitaetsklinikum Essen, Westdeutsches Tumorzentrum | Essen | Hufelandstraße 55 | 45147 | Germany |
| Diakonie-Klinikum Schwabisch Hall | Schwäbisch Hall | Innere Medizin III | 74523 | Germany |
| UBAG MVZ Mitte/ MVZ Delitzsch GmbH | Delitzsch | Ludwig- Jahn- Str. 4 | 04509 | Germany |
| Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen | München | Marchioninistr. 15 | 81377 | Germany |
| Stadtisches Klinikum Karlsruhe | Karlsruhe | Medizinische Klinik III | 76133 | Germany |
| Schwerpunktpraxis und Tagesklinik fur Hamatologie und Onkologie | Kronach | Niederbronner Stabe 2 | 96317 | Germany |
| Klinikum Lippe-Lemgo | Minden | Rintelner Strae 85 | 32657 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | Schwanebecker Chaussee 50 | 13125 | Germany |
| Malteser Krankenhaus St. Franziskus Hospital | Flensburg | Waldstr. 17 | 24939 | Germany |
| Dr. Reiner Weinberg, Md, Office Of | Aachen | Weberstr. 8 | 52064 | Germany |
| Evangelisches Krankenhaus Hamm GgmbH | Hamm | Werler Str. 110 | 59063 | Germany |
| Carl-Thiem-Klinikum Cottbus | Cottbus | 03048 | Germany |
| Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3 | Frankfurt | 65929 | Germany |
| GP Dres. Verpoort | Hamburg | 20095 | Germany |
| Uberortliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Dres. Verpoort, Wierecky & Zeller | Hamburg | 20259 | Germany |
| Praxis Dr Schwarzer | Leipzig | 04289 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Klinik für Hämatologie, Onkologie und Palliativmedizin Mühlenkreiskliniken, Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers | Moers | 47441 | Germany |
| Stauferklinikum Schwaebisch Gmuend | Mutlangen | 73557 | Germany |
| Zentrum für Innere Medizin | Mutlangen | 73557 | Germany |
| Studienzentrum Onkologie Ravensburg | Ravensburg | 88212 | Germany |
| Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | FG | 71013 | Italy |
| AOUC Azienda Ospedaliero-Universitaria Careggi | Florence | Florence | 50134 | Italy |
| Reparto Di Ematologia Dell'Azienda | Brescia | Lombardy | 25133 | Italy |
| Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli' | Naples | Naples | 80131 | Italy |
| Institute of Hematology- Sapienza University -Rome, Italy | Roma | Rome | 00161 | Italy |
| Azienda Ospedaliera Universitaria di Padova | Padova | Veneto | 35128 | Italy |
| Azienda Ospedaliera Univarsitaria Consorziale Policlinico di Bari | Bari | 70124 | Italy |
| Azienda Ospedaliera Ospedali Riuniti di Bergamo | Bergamo | 24128 | Italy |
| AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna | Bologna | 40138 | Italy |
| Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia | Brescia | 25123 | Italy |
| Centro Trapianti Midollo Osseo Ospedale Bnaghi | Cagliari | 2-09126 | Italy |
| A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto | Catania | 95124 | Italy |
| Azienda Ospedaliera Universitaria "San Martino" | Genova | 16132 | Italy |
| Ospedale San Raffaele Srl | Milan | 20132 | Italy |
| Ematologia, Policlinico di Milano | Milan | 20122 | Italy |
| Casa di Cura La Maddalena | Palermo | 90146 | Italy |
| AOUP, Santa Chiara Hospital | Pisa | 56123 | Italy |
| A.O. Bianchi Melacrino Morelli | Reggio Calabria | 89133 | Italy |
| Arcispedale S. Maria Nuova | Reggio Emilia | 42121 | Italy |
| Policlinico S.Eugenio | Roma | 0144 | Italy |
| A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC | Salerno | 84131 | Italy |
| AOU Ospedali Riuniti Umbertio I | Torrette Di Ancona | 60126 | Italy |
| U.O Ematologia Az. ULSS9 di Treviso | Treviso | 31100 | Italy |
| Unita di Oncologia Polmonare A.o. San | Turin | 10043 | Italy |
| Universita Degli Studi Policlinico | Udine | 33100 | Italy |
| HF Alesund Hospital | Ålesund | NO-6026 | Norway |
| Helse Bergen HF Haukeland University Hospital | Bergen | NO-5021 | Norway |
| Vestre Viken/Baerums sjukhus | Drammen | 3004 | Norway |
| Fredrikstad Hospital | Fredrikstad | N-1603 | Norway |
| Hospital Costa Del Sol | Marbella | Autovia A-7, Km 187 | 29603 | Spain |
| University Hospital Reina Sofia | Córdoba | Avda Menendez Pidal S/n | 14004 | Spain |
| Nuestra Senora de Valme | Seville | Avda. Bellavista, S/N | 41014 | Spain |
| Hospital Puerta del Mar | Cadiz | Avenida Ana de Viya, 21 | CP 11009 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Avenida de Roma S/n | 33011 | Spain |
| General de Jane | Jaén | Avenida Ejercito Espanol 10 | 23007 | Spain |
| General San Pedro de Alcantara | Cáceres | Avenida Pablo Naranjo Porras | 10003 | Spain |
| Hospital Clinico Universitario De Valladolid | Valladolid | Avenida Ramon Y Cajal 3 | 47005 | Spain |
| Hospital Universitario de La Princesa | Madrid | C/ Diego de León 62, 3a Planta | 28006 | Spain |
| Hospital Xeral de Lugo | Lugo | C/ Doctor Severo Ochoa S/N | 27004 | Spain |
| Hospital Son Dureta | Palma de Mallorca | Calle Andrea Doria 55 | 07014 | Spain |
| Hospital General Universitario Santa Lucia | Cartagena (murcia) | Calle Mezquita | 30202 | Spain |
| Hospital Arnau De Vilanova De Valencia | Valencia | Calle San Clemente, 12 | 46015 | Spain |
| Hospital General Universitario de Elche | Elche | CAMI de L´almassera 11 | 03203 | Spain |
| Hospital de Cabuenes | Gijón | Camino de Los Prados | 395-33203 | Spain |
| Hospital Universitario Nuestra Senora De Candelaria | Santa Cruz de Tenerife | Carretera Del Rosario, 145 | 38010 | Spain |
| Hospital Fundacion Son Llatzer | Palma de Mallorca | Ctra. Manacor, Km. 4 | 07198 | Spain |
| Hospital universitario de Alava | Alava | Jose Achotegui | 01009 | Spain |
| IC0 Duran y Reynalds | Barcelona | L´Hospitalet de Llobregat | 08908 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Passeig de La Vall D'Hebron 119-129 | 08035 | Spain |
| Ctra. Orihuela - Almoradi | Orihuela (alicante) | S/N San Bartolome | 03314 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Servicio de Oncologia | 29010 | Spain |
| Sunderby Hospital | Luleå | 97180 | Sweden |
| University Hospital UMEA | Umeå | 901 85 | Sweden |
| Pinderfields Hospital-Mid Yorkshire Nhs Trust | Wakefield | Aberford Road | WF14DG | United Kingdom |
| Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust | Doncaster | Armthorpe Road | DN25LT | United Kingdom |
| Northhampton Gerneral Hospital | Northampton | Cliftonville | NN1 5BD | United Kingdom |
| County Durham and Darlington NHS foundation Trust | County Durham | Darlington Memorial Hospital | DL3 6HX | United Kingdom |
| Broomfield Hospital | Broomfield,Chelmsford | Essex | CM1 7ET | United Kingdom |
| Aberdeen Royal Infirmary - Nhs Grampian | Aberdeen | Foresterhill Road | AB25 2ZN | United Kingdom |
| The Newcastle Upon Tyne Hospitals Nhs Foundation | Newcastle upon Tyne | Freeman Hospital | NE7 7DN | United Kingdom |
| Lincoln County Hospital - United Lincolnshire Hospitals Nhs Trust | Lincoln | Greetwell Road | LN2 5QY | United Kingdom |
| Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre | Maidstone | Kent | ME16 9QQ | United Kingdom |
| Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust | Blackpool | Lancashire | FY3 8NR | United Kingdom |
| Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust | Huddersfield | Lindley | HD3 3EA | United Kingdom |
| Worthing Hospital - Western Sussex Hospitals Nhs Trust | Worthing | Lyndhurst Road | BN11 2DH | United Kingdom |
| Monklands Hospital Trust: Nhs Lanarkshire - Acute Services Division | Airdrie | Monkscourt Avenue | ML6 OJS | United Kingdom |
| Southmead Hospital - North Bristol Nhs Trust Recruiting | Bristol | Southmead Road | BS10 5NB | United Kingdom |
| City Hospitals Sunderland NHS Trust Recruiting | Sunderland | Sunderland Royal Hospital | SR4 7TP | United Kingdom |
| Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust | Colchester | Turner Road | CO4 5JL | United Kingdom |
| University Hospital of Wales | Cardiff | Vale Of Glamorgan | CF14 4XW | United Kingdom |
| Northwick Park Hospital - North West London Hospitals Nhs Trust | Harrow | Watford Road | HA1 3UJ | United Kingdom |
| Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust | Swansea | West Glamorgan | SA2 8QA | United Kingdom |
| Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital | Worcester | Worcestershire | WR5 1DD | United Kingdom |
| St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust | Carshalton | Wrythe Lane | SM5 1AA | United Kingdom |
| Basingstoke and North Hampshire Hospital | Basingstoke | RG24 9NA | United Kingdom |
| Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust | Bath | BA1 3NG | United Kingdom |
| Dorset County Hospital | Dorchester | DT1 2JY | United Kingdom |
| The Royal Liverpool and Broadgreen -University Hospitals NHS | Liverpool | L7 8XP | United Kingdom |
| Specialist Cancer Pharmacist-Oxford Cancer Centre & Cancer Research UK-Churchill Hospital-Oxford University Hospitals NHS Trust | Oxford | OX3 7LJ | United Kingdom |
| Royal Berkshire hospital | Reading | RG1 5AN | United Kingdom |
| Wexham Park Hospital | Slough | SL2 4HL | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital | Tyne and Wear | NE29 8NH | United Kingdom |
| Background |
| 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. |
| 29802551 | Background | 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. |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
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