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A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02164955
Recruitment Status : Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
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 up prospectively for up to 3 years following the end of pomalidomide treatment. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.


Condition or disease Intervention/treatment
Multiple Myeloma Drug: IMNOVID

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Study Type : Observational [Patient Registry]
Actual Enrollment : 775 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : June 26, 2014
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Relapsed and Refractory Multiple Myeloma Patients
Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
Drug: IMNOVID
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Other Name: pomalidomide




Primary Outcome Measures :
  1. Determine incidence of risks as outlined in the Risk Management Plan [ Time Frame: Up to 5 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 :
  1. Pregnancy Prevention Programme Effectiveness [ Time Frame: Up to 5 years ]
    To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry


Other Outcome Measures:
  1. Previous Treatments [ Time Frame: Approximately 6 months ]
    To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164955


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

Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02164955     History of Changes
Other Study ID Numbers: CC-4047-MM-015
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

Keywords provided by Celgene:
Pomalidomide
Multiple Myeloma
Relapsed, Refractory
Observational
Imnovid
Registry
Post-approval
Safety

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pomalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents