A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
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
1 other identifier
observational
775
8 countries
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Longer than P75 for all trials
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedStudy Start
First participant enrolled
June 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2022
CompletedOctober 20, 2022
October 1, 2022
8.3 years
June 13, 2014
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Pregnancy Prevention Programme Effectiveness
Up to 3 years
Previous Treatments
Approximately 6 months
Study Arms (1)
Relapsed and Refractory Multiple Myeloma Patients
Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
Interventions
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (122)
Cliniques Universitaires Saint Luc
Brussels, Avenue Hippocrate 10, 01200, Belgium
Ziekenhuis Netwerk Antwerpen- Campus Middelheim
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'
Napoli, Naples, 80131, Italy
Institute of Hematology- Sapienza University -Rome, Italy
Roma, Rome, 00161, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, 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
Related Publications (3)
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.
PMID: 28504846BACKGROUNDSchafer 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.
PMID: 29945920BACKGROUNDDinner 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.
PMID: 29802551BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 17, 2014
Study Start
June 26, 2014
Primary Completion
October 10, 2022
Study Completion
October 10, 2022
Last Updated
October 20, 2022
Record last verified: 2022-10