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

October 18, 2022 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

775

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Arlon, Belgium, 6700
        • Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Liege, Belgium, 4000
        • CHC
      • Ottignies, Belgium, 1340
        • Clinique Saint-Pierre
    • Avenue Hippocrate 10
      • Bruxelles, Avenue Hippocrate 10, Belgium, 01200
        • Cliniques Universitaires Saint Luc
    • Lindendreef 1
      • Antwerpen, Lindendreef 1, Belgium, 02020
        • Ziekenhuis Netwerk Antwerpen- Campus Middelheim
    • Lodewijk De Meesterstraat 5
      • Sint-Niklaas, Lodewijk De Meesterstraat 5, Belgium, 09100
        • AZ Nikolaas
    • Rue Du Parc 29
      • Verviers, Rue Du Parc 29, Belgium, 4800
        • Centre Hospitalier Peltzer-La Tourelle
    • Rue Ferrer 159
      • La Louviere, Rue Ferrer 159, Belgium, 7100
        • Centre Hospitalier de Jolimont
  • Denmark
      • Vejle, Denmark, 7100
        • Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25
    • Kloevervanget 10
      • Odense, Kloevervanget 10, Denmark, 05000
        • Odense Hospital
    • Noerrebrogade 44
      • Midtjylland, Noerrebrogade 44, Denmark, 8000
        • Aarhus Universitetshospital
  • Germany
      • Cottbus, Germany, 03048
        • Carl-Thiem-Klinikum Cottbus
      • Frankfurt, Germany, 65929
        • Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3
      • Hamburg, Germany, 20095
        • GP Dres. Verpoort
      • Hamburg, Germany, 20259
        • Uberortliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Dres. Verpoort, Wierecky & Zeller
      • Leipzig, Germany, 04289
        • Praxis Dr Schwarzer
      • Minden, Germany, 32429
        • Johannes Wesling Klinikum Minden
      • Minden, Germany, 32429
        • Klinik für Hämatologie, Onkologie und Palliativmedizin Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
      • Moers, Germany, 47441
        • Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers
      • Mutlangen, Germany, 73557
        • Stauferklinikum Schwaebisch Gmuend
      • Mutlangen, Germany, 73557
        • Zentrum für Innere Medizin
      • Ravensburg, Germany, 88212
        • Studienzentrum Onkologie Ravensburg
    • Buchforststr 14
      • Koln-Kalk, Buchforststr 14, Germany, 51103
        • Gemeinschaftspraxis für Hämatologie und Onkologie
    • Chariteplatz 1
      • Berlin, Chariteplatz 1, Germany, 10117
        • Charite der Humboldt-Universität
    • Charlotteustr 72
      • Potsdam, Charlotteustr 72, Germany, 14467
        • Klinikum Enroll von Bergmann
    • Cuno-Niggl-Strate 3
      • Traunstein, Cuno-Niggl-Strate 3, Germany, 83278
        • Klinikum Traunstein
    • Elisenstr.26
      • Aschaffenburg, Elisenstr.26, Germany, 63877
        • Studienzentrum Haematologie/Onkologie/Diabetologie
    • Hufelandstraße 55
      • Essen, Hufelandstraße 55, Germany, 45147
        • Universitaetsklinikum Essen, Westdeutsches Tumorzentrum
    • Innere Medizin III
      • Schwabisch Hall, Innere Medizin III, Germany, 74523
        • Diakonie-Klinikum Schwäbisch Hall
    • Ludwig- Jahn- Str. 4
      • Delitzsch, Ludwig- Jahn- Str. 4, Germany, 04509
        • UBAG MVZ Mitte/ MVZ Delitzsch GmbH
    • Marchioninistr. 15
      • Muenchen, Marchioninistr. 15, Germany, 81377
        • Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen
    • Medizinische Klinik III
      • Karlsruhe, Medizinische Klinik III, Germany, 76133
        • Städtisches Klinikum Karlsruhe
    • Niederbronner Stabe 2
      • Kronach, Niederbronner Stabe 2, Germany, 96317
        • Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
    • Rintelner Strae 85
      • Minden, Rintelner Strae 85, Germany, 32657
        • Klinikum Lippe-Lemgo
    • Schwanebecker Chaussee 50
      • Berlin, Schwanebecker Chaussee 50, Germany, 13125
        • Helios Klinikum Berlin-Buch
    • Waldstr. 17
      • Flensburg, Waldstr. 17, Germany, 24939
        • Malteser Krankenhaus St. Franziskus Hospital
    • Weberstr. 8
      • Aachen, Weberstr. 8, Germany, 52064
        • Dr. Reiner Weinberg, Md, Office Of
    • Werler Str. 110
      • Hamm, Werler Str. 110, Germany, 59063
        • Evangelisches Krankenhaus Hamm gGmbH
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliera Univarsitaria Consorziale Policlinico di Bari
      • Bergamo, Italy, 24128
        • Azienda Ospedaliera Ospedali Riuniti di Bergamo
      • Bologna, Italy, 40138
        • AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
      • Cagliari, Italy, 2-09126
        • Centro Trapianti Midollo Osseo Ospedale Bnaghi
      • Catania, Italy, 95124
        • A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria "San Martino"
      • Milan, Italy, 20132
        • Ospedale San Raffaele SRL
      • Milano, Italy, 20122
        • Ematologia, Policlinico di Milano
      • Palermo, Italy, 90146
        • Casa di Cura La Maddalena
      • Pisa, Italy, 56123
        • AOUP, Santa Chiara Hospital
      • Reggio Calabria, Italy, 89133
        • A.O. Bianchi Melacrino Morelli
      • Reggio Emilia, Italy, 42121
        • Arcispedale S. Maria Nuova
      • Roma, Italy, 0144
        • Policlinico S.Eugenio
      • Salerno, Italy, 84131
        • A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
      • Torrette Di Ancona, Italy, 60126
        • AOU Ospedali Riuniti Umbertio I
      • Treviso, Italy, 31100
        • U.O Ematologia Az. ULSS9 di Treviso
      • Turin, Italy, 10043
        • Unita di Oncologia Polmonare A.o. San
      • Udine, Italy, 33100
        • Universita Degli Studi Policlinico
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza
    • Florence
      • Firenze, Florence, Italy, 50134
        • AOUC Azienda Ospedaliero-Universitaria Careggi
    • Lombardy
      • Brescia, Lombardy, Italy, 25133
        • Reparto Di Ematologia Dell'Azienda
    • Naples
      • Napoli, Naples, Italy, 80131
        • Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli'
    • Rome
      • Roma, Rome, Italy, 00161
        • Institute of Hematology- Sapienza University -Rome, Italy
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Azienda Ospedaliera Universitaria di Padova
  • Norway
      • Alesund, Norway, NO-6026
        • HF Alesund Hospital
      • Bergen, Norway, NO-5021
        • Helse Bergen HF Haukeland University Hospital
      • Drammen, Norway, 3004
        • Vestre Viken/Baerums sjukhus
      • Fredrikstad, Norway, N-1603
        • Fredrikstad Hospital
  • Spain
    • Autovia A-7, Km 187
      • Marbella, Autovia A-7, Km 187, Spain, 29603
        • Hospital Costa del Sol
    • Avda Menendez Pidal S/n
      • Cordoba, Avda Menendez Pidal S/n, Spain, 14004
        • University Hospital Reina Sofia
    • Avda. Bellavista, S/N
      • Sevilla, Avda. Bellavista, S/N, Spain, 41014
        • Nuestra Senora de Valme
    • Avenida Ana De Viya, 21
      • Cadiz, Avenida Ana De Viya, 21, Spain, CP 11009
        • Hospital Puerta del Mar
    • Avenida De Roma S/n
      • Oviedo, Avenida De Roma S/n, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Avenida Ejercito Espanol 10
      • Jaen, Avenida Ejercito Espanol 10, Spain, 23007
        • General de Jane
    • Avenida Pablo Naranjo Porras
      • Caceres, Avenida Pablo Naranjo Porras, Spain, 10003
        • General San Pedro de Alcantara
    • Avenida Ramon Y Cajal 3
      • Valladolid, Avenida Ramon Y Cajal 3, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
    • C/ Diego De León 62, 3a Planta
      • Madrid, C/ Diego De León 62, 3a Planta, Spain, 28006
        • Hospital Universitario de La Princesa
    • C/ Doctor Severo Ochoa S/N
      • Lugo, C/ Doctor Severo Ochoa S/N, Spain, 27004
        • Hospital Xeral de Lugo
    • CAMI DE L´almassera 11
      • Elche, CAMI DE L´almassera 11, Spain, 03203
        • Hospital General Universitario de Elche
    • Calle Andrea Doria 55
      • Palma De Mallorca, Calle Andrea Doria 55, Spain, 07014
        • Hospital Son Dureta
    • Calle Mezquita
      • Cartagena (murcia), Calle Mezquita, Spain, 30202
        • Hospital General Universitario Santa Lucía
    • Calle San Clemente, 12
      • Valencia, Calle San Clemente, 12, Spain, 46015
        • Hospital Arnau de Vilanova de Valencia
    • Camino De Los Prados
      • Gijon, Camino De Los Prados, Spain, 395-33203
        • Hospital de Cabueñes
    • Carretera Del Rosario, 145
      • Tenerife, Carretera Del Rosario, 145, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
    • Ctra. Manacor, Km. 4
      • Palma de Mallorca, Ctra. Manacor, Km. 4, Spain, 07198
        • Hospital Fundacion Son Llatzer
    • Jose Achotegui
      • Alava, Jose Achotegui, Spain, 01009
        • Hospital Universitario de Alava
    • L´Hospitalet De Llobregat
      • Barcelona, L´Hospitalet De Llobregat, Spain, 08908
        • IC0 Duran y Reynalds
    • Passeig De La Vall D'Hebron 119-129
      • Barcelona, Passeig De La Vall D'Hebron 119-129, Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • S/N San Bartolome
      • Orihuela (alicante), S/N San Bartolome, Spain, 03314
        • Ctra. Orihuela - Almoradi
    • Servicio De Oncologia
      • Malaga, Servicio De Oncologia, Spain, 29010
        • Hospital Universitario Virgen De La Victoria
  • Sweden
      • Lulea, Sweden, 97180
        • Sunderby Hospital
      • Umea, Sweden, 901 85
        • University Hospital Umeå
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire Hospital
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Liverpool, United Kingdom, L7 8XP
        • The Royal Liverpool and Broadgreen -University Hospitals NHS
      • Oxford, United Kingdom, OX3 7LJ
        • Specialist Cancer Pharmacist-Oxford Cancer Centre & Cancer Research UK-Churchill Hospital-Oxford University Hospitals NHS Trust
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Slough, United Kingdom, SL2 4HL
        • Wexham Park Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Tyne And Wear, United Kingdom, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital
    • Aberford Road
      • Wakefield, Aberford Road, United Kingdom, WF14DG
        • Pinderfields Hospital-Mid Yorkshire Nhs Trust
    • Armthorpe Road
      • Doncaster, Armthorpe Road, United Kingdom, DN25LT
        • Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
    • Cliftonville
      • Northampton, Cliftonville, United Kingdom, NN1 5BD
        • Northhampton Gerneral Hospital
    • Darlington Memorial Hospital
      • County Durham, Darlington Memorial Hospital, United Kingdom, DL3 6HX
        • County Durham and Darlington NHS Foundation Trust
    • Essex
      • Broomfield,Chelmsford, Essex, United Kingdom, CM1 7ET
        • Broomfield Hospital
    • Foresterhill Road
      • Aberdeen, Foresterhill Road, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary - NHS Grampian
    • Freeman Hospital
      • Newcastle Upon Tyne, Freeman Hospital, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals Nhs Foundation
    • Greetwell Road
      • Lincoln, Greetwell Road, United Kingdom, LN2 5QY
        • Lincoln County Hospital - United Lincolnshire Hospitals Nhs Trust
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust
    • Lindley
      • Huddersfield, Lindley, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust
    • Lyndhurst Road
      • Worthing, Lyndhurst Road, United Kingdom, BN11 2DH
        • Worthing Hospital - Western Sussex Hospitals Nhs Trust
    • Monkscourt Avenue
      • Airdrie, Monkscourt Avenue, United Kingdom, ML6 OJS
        • Monklands Hospital Trust: Nhs Lanarkshire - Acute Services Division
    • Southmead Road
      • Bristol, Southmead Road, United Kingdom, BS10 5NB
        • Southmead Hospital - North Bristol Nhs Trust Recruiting
    • Sunderland Royal Hospital
      • Sunderland, Sunderland Royal Hospital, United Kingdom, SR4 7TP
        • City Hospitals Sunderland NHS Trust Recruiting
    • Turner Road
      • Colchester, Turner Road, United Kingdom, CO4 5JL
        • Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust
    • Vale Of Glamorgan
      • Cardiff, Vale Of Glamorgan, United Kingdom, CF14 4XW
        • University Hospital of Wales
    • Watford Road
      • Harrow, Watford Road, United Kingdom, HA1 3UJ
        • Northwick Park Hospital - North West London Hospitals Nhs Trust
    • West Glamorgan
      • Swansea, West Glamorgan, United Kingdom, SA2 8QA
        • Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust
    • Worcestershire
      • Worcester, Worcestershire, United Kingdom, WR5 1DD
        • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
    • Wrythe Lane
      • Carshalton, Wrythe Lane, United Kingdom, SM5 1AA
        • St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • CC-4047
  • pomalidomide
  • BMS-986379

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine incidence of risks as outlined in the Risk Management Plan
Time Frame: Up to 3 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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Prevention Programme Effectiveness
Time Frame: Up to 3 years
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
Time Frame: Approximately 6 months
To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).
Approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2014

Primary Completion (Actual)

October 10, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-4047-MM-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on IMNOVID

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe