Clinical trial NCT02164955: A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Pomalidomide
Multiple Myeloma
Relapsed, Refractory
Observational
Imnovid
Registry
Post-approval
Safety
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-06-17
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine incidence of risks as outlined in the Risk Management Plan
timeFrame: Up to 3 years
Secondary outcomes:
measure: Pregnancy Prevention Programme Effectiveness
timeFrame: Up to 3 years
measure: Previous Treatments
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
state: Avenue Hippocrate 10
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen- Campus Middelheim
state: Lindendreef 1
city: Sint-Niklaas
country: Belgium
facility: Az Nikolaas
state: Lodewijk De Meesterstraat 5
city: Verviers
country: Belgium
facility: Centre Hospitalier Peltzer-La Tourelle
state: Rue Du Parc 29
city: La Louviere
country: Belgium
facility: Centre hospitalier de Jolimont
state: Rue Ferrer 159
city: Arlon
country: Belgium
facility: Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Liege
country: Belgium
facility: CHC
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
city: Odense
country: Denmark
facility: Odense Hospital
state: Kloevervanget 10
city: Midtjylland
country: Denmark
facility: Aarhus Universitetshospital
state: Noerrebrogade 44
city: Vejle
country: Denmark
facility: Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25
city: Koln-Kalk
country: Germany
facility: Gemeinschaftspraxis Fur Hamatologie Und Onkologie
state: Buchforststr 14
city: Berlin
country: Germany
facility: Charite der Humboldt-Universität
state: Chariteplatz 1
city: Potsdam
country: Germany
facility: Klinikum Enroll von Bergmann
state: Charlotteustr 72
city: Traunstein
country: Germany
facility: Klinikum Traunstein
state: Cuno-Niggl-Strate 3
city: Aschaffenburg
country: Germany
facility: Studienzentrum Haematologie/Onkologie/Diabetologie
state: Elisenstr.26
city: Essen
country: Germany
facility: Universitaetsklinikum Essen, Westdeutsches Tumorzentrum
state: Hufelandstraße 55
city: Schwabisch Hall
country: Germany
facility: Diakonie-Klinikum Schwabisch Hall
state: Innere Medizin III
city: Delitzsch
country: Germany
facility: UBAG MVZ Mitte/ MVZ Delitzsch GmbH
state: Ludwig- Jahn- Str. 4
city: Muenchen
country: Germany
facility: Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen
state: Marchioninistr. 15
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum Karlsruhe
state: Medizinische Klinik III
city: Kronach
country: Germany
facility: Schwerpunktpraxis und Tagesklinik fur Hamatologie und Onkologie
state: Niederbronner Stabe 2
city: Minden
country: Germany
facility: Klinikum Lippe-Lemgo
state: Rintelner Strae 85
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
state: Schwanebecker Chaussee 50
city: Flensburg
country: Germany
facility: Malteser Krankenhaus St. Franziskus Hospital
state: Waldstr. 17
city: Aachen
country: Germany
facility: Dr. Reiner Weinberg, Md, Office Of
state: Weberstr. 8
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm GgmbH
state: Werler Str. 110
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3
city: Hamburg
country: Germany
facility: GP Dres. Verpoort
city: Hamburg
country: Germany
facility: Uberortliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Dres. Verpoort, Wierecky & Zeller
city: Leipzig
country: Germany
facility: Praxis Dr Schwarzer
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Minden
country: Germany
facility: Klinik für Hämatologie, Onkologie und Palliativmedizin Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
city: Moers
country: Germany
facility: Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend
city: Mutlangen
country: Germany
facility: Zentrum für Innere Medizin
city: Ravensburg
country: Germany
facility: Studienzentrum Onkologie Ravensburg
city: San Giovanni Rotondo
country: Italy
facility: Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza
state: FG
city: Firenze
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi
state: Florence
city: Brescia
country: Italy
facility: Reparto Di Ematologia Dell'Azienda
state: Lombardy
city: Napoli
country: Italy
facility: Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli'
state: Naples
city: Roma
country: Italy
facility: Institute of Hematology- Sapienza University -Rome, Italy
state: Rome
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
state: Veneto
city: Bari
country: Italy
facility: Azienda Ospedaliera Univarsitaria Consorziale Policlinico di Bari
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti di Bergamo
city: Bologna
country: Italy
facility: AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
city: Cagliari
country: Italy
facility: Centro Trapianti Midollo Osseo Ospedale Bnaghi
city: Catania
country: Italy
facility: A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria "San Martino"
city: Milano
country: Italy
facility: Ematologia, Policlinico di Milano
city: Milan
country: Italy
facility: Ospedale San Raffaele Srl
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
city: Pisa
country: Italy
facility: AOUP, Santa Chiara Hospital
city: Reggio Calabria
country: Italy
facility: A.O. Bianchi Melacrino Morelli
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Roma
country: Italy
facility: Policlinico S.Eugenio
city: Salerno
country: Italy
facility: A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
city: Torrette Di Ancona
country: Italy
facility: AOU Ospedali Riuniti Umbertio I
city: Treviso
country: Italy
facility: U.O Ematologia Az. ULSS9 di Treviso
city: Turin
country: Italy
facility: Unita di Oncologia Polmonare A.o. San
city: Udine
country: Italy
facility: Universita Degli Studi Policlinico
city: Alesund
country: Norway
facility: HF Alesund Hospital
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken/Baerums sjukhus
city: Fredrikstad
country: Norway
facility: Fredrikstad Hospital
city: Marbella
country: Spain
facility: Hospital Costa Del Sol
state: Autovia A-7, Km 187
city: Cordoba
country: Spain
facility: University Hospital Reina Sofia
state: Avda Menendez Pidal S/n
city: Sevilla
country: Spain
facility: Nuestra Senora de Valme
state: Avda. Bellavista, S/N
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
state: Avenida Ana De Viya, 21
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Avenida De Roma S/n
city: Jaen
country: Spain
facility: General de Jane
state: Avenida Ejercito Espanol 10
city: Caceres
country: Spain
facility: General San Pedro de Alcantara
state: Avenida Pablo Naranjo Porras
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario De Valladolid
state: Avenida Ramon Y Cajal 3
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
state: C/ Diego De León 62, 3a Planta
city: Lugo
country: Spain
facility: Hospital Xeral de Lugo
state: C/ Doctor Severo Ochoa S/N
city: Palma De Mallorca
country: Spain
facility: Hospital Son Dureta
state: Calle Andrea Doria 55
city: Cartagena (murcia)
country: Spain
facility: Hospital General Universitario Santa Lucia
state: Calle Mezquita
city: Valencia
country: Spain
facility: Hospital Arnau De Vilanova De Valencia
state: Calle San Clemente, 12
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: CAMI DE L´almassera 11
city: Gijon
country: Spain
facility: Hospital de Cabuenes
state: Camino De Los Prados
city: Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora De Candelaria
state: Carretera Del Rosario, 145
city: Palma de Mallorca
country: Spain
facility: Hospital Fundacion Son Llatzer
state: Ctra. Manacor, Km. 4
city: Alava
country: Spain
facility: Hospital universitario de Alava
state: Jose Achotegui
city: Barcelona
country: Spain
facility: IC0 Duran y Reynalds
state: L´Hospitalet De Llobregat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Passeig De La Vall D'Hebron 119-129
city: Orihuela (alicante)
country: Spain
facility: Ctra. Orihuela - Almoradi
state: S/N San Bartolome
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Servicio De Oncologia
city: Lulea
country: Sweden
facility: Sunderby Hospital
city: Umea
country: Sweden
facility: University Hospital UMEA
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital-Mid Yorkshire Nhs Trust
state: Aberford Road
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
state: Armthorpe Road
city: Northampton
country: United Kingdom
facility: Northhampton Gerneral Hospital
state: Cliftonville
city: County Durham
country: United Kingdom
facility: County Durham and Darlington NHS foundation Trust
state: Darlington Memorial Hospital
city: Broomfield,Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - Nhs Grampian
state: Foresterhill Road
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals Nhs Foundation
state: Freeman Hospital
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital - United Lincolnshire Hospitals Nhs Trust
state: Greetwell Road
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre
state: Kent
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust
state: Lancashire
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust
state: Lindley
city: Worthing
country: United Kingdom
facility: Worthing Hospital - Western Sussex Hospitals Nhs Trust
state: Lyndhurst Road
city: Airdrie
country: United Kingdom
facility: Monklands Hospital Trust: Nhs Lanarkshire - Acute Services Division
state: Monkscourt Avenue
city: Bristol
country: United Kingdom
facility: Southmead Hospital - North Bristol Nhs Trust Recruiting
state: Southmead Road
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS Trust Recruiting
state: Sunderland Royal Hospital
city: Colchester
country: United Kingdom
facility: Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust
state: Turner Road
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Vale Of Glamorgan
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital - North West London Hospitals Nhs Trust
state: Watford Road
city: Swansea
country: United Kingdom
facility: Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust
state: West Glamorgan
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
state: Worcestershire
city: Carshalton
country: United Kingdom
facility: St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust
state: Wrythe Lane
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool and Broadgreen -University Hospitals NHS
city: Oxford
country: United Kingdom
facility: Specialist Cancer Pharmacist-Oxford Cancer Centre & Cancer Research UK-Churchill Hospital-Oxford University Hospitals NHS Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire hospital
city: Slough
country: United Kingdom
facility: Wexham Park Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Tyne And Wear
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.