AzTrials
AzTrials

Multiple MyelomaNCT02164955

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

An observational study of Multiple Myeloma, run by Celgene at 122 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
IMNOVID
How many people
775 participants
Where
122 sitesin 8 countries
Study dates
26 Jun 2014to 10 Oct 2022
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

122 sites in 8 countries.

122 sites in 8 countries

United Kingdom30 sites

  • Aberdeen Royal Infirmary - Nhs Grampian

    Aberdeen, Foresterhill Road, AB25 2ZN

  • Monklands Hospital Trust: Nhs Lanarkshire - Acute Services Division

    Airdrie, Monkscourt Avenue, ML6 OJS

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA

  • Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust

    Bath, BA1 3NG

  • Blackpool Victoria Hospital - Blackpool, Fylde And Wyre Hospitals Nhs Foundation Trust

    Blackpool, Lancashire, FY3 8NR

  • Southmead Hospital - North Bristol Nhs Trust Recruiting

    Bristol, Southmead Road, BS10 5NB

  • Broomfield Hospital

    Broomfield,Chelmsford, Essex, CM1 7ET

  • University Hospital of Wales

    Cardiff, Vale Of Glamorgan, CF14 4XW

  • St Helier Hospital - Epsom and St Helier University Hospitals NHS Trust

    Carshalton, Wrythe Lane, SM5 1AA

  • Colchester General Hospital - Colchester Hospital University Nhs Foundation Trust

    Colchester, Turner Road, CO4 5JL

  • County Durham and Darlington NHS foundation Trust

    County Durham, Darlington Memorial Hospital, DL3 6HX

  • Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust

    Doncaster, Armthorpe Road, DN25LT

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • Northwick Park Hospital - North West London Hospitals Nhs Trust

    Harrow, Watford Road, HA1 3UJ

  • Huddersfield Royal Infirmary - Calderdale And Huddersfield Nhs Foundation Trust

    Huddersfield, Lindley, HD3 3EA

  • Lincoln County Hospital - United Lincolnshire Hospitals Nhs Trust

    Lincoln, Greetwell Road, LN2 5QY

  • The Royal Liverpool and Broadgreen -University Hospitals NHS

    Liverpool, L7 8XP

  • Maidstone Hospital - Maidstone And Tunbridge Wells Nhs Trust-Kent Oncology Centre

    Maidstone, Kent, ME16 9QQ

  • The Newcastle Upon Tyne Hospitals Nhs Foundation

    Newcastle upon Tyne, Freeman Hospital, NE7 7DN

  • Northhampton Gerneral Hospital

    Northampton, Cliftonville, NN1 5BD

  • Specialist Cancer Pharmacist-Oxford Cancer Centre & Cancer Research UK-Churchill Hospital-Oxford University Hospitals NHS Trust

    Oxford, OX3 7LJ

  • Royal Berkshire hospital

    Reading, RG1 5AN

  • Wexham Park Hospital

    Slough, SL2 4HL

  • City Hospitals Sunderland NHS Trust Recruiting

    Sunderland, Sunderland Royal Hospital, SR4 7TP

  • Singleton Hospital - Abertawe Bro Morgannwg University Nhs Trust

    Swansea, West Glamorgan, SA2 8QA

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • Northumbria Healthcare NHS Foundation Trust North Tyneside Hospital

    Tyne and Wear, NE29 8NH

  • Pinderfields Hospital-Mid Yorkshire Nhs Trust

    Wakefield, Aberford Road, WF14DG

  • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

    Worcester, Worcestershire, WR5 1DD

  • Worthing Hospital - Western Sussex Hospitals Nhs Trust

    Worthing, Lyndhurst Road, BN11 2DH

Other trials in United Kingdom

Germany27 sites

  • Dr. Reiner Weinberg, Md, Office Of

    Aachen, Weberstr. 8, 52064

  • Studienzentrum Haematologie/Onkologie/Diabetologie

    Aschaffenburg, Elisenstr.26, 63877

  • Charite der Humboldt-Universität

    Berlin, Chariteplatz 1, 10117

  • HELIOS Klinikum Berlin-Buch

    Berlin, Schwanebecker Chaussee 50, 13125

  • Carl-Thiem-Klinikum Cottbus

    Cottbus, 03048

  • UBAG MVZ Mitte/ MVZ Delitzsch GmbH

    Delitzsch, Ludwig- Jahn- Str. 4, 04509

  • Universitaetsklinikum Essen, Westdeutsches Tumorzentrum

    Essen, Hufelandstraße 55, 45147

  • Malteser Krankenhaus St. Franziskus Hospital

    Flensburg, Waldstr. 17, 24939

  • Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3

    Frankfurt, 65929

  • GP Dres. Verpoort

    Hamburg, 20095

  • Uberortliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Dres. Verpoort, Wierecky & Zeller

    Hamburg, 20259

  • Evangelisches Krankenhaus Hamm GgmbH

    Hamm, Werler Str. 110, 59063

  • Stadtisches Klinikum Karlsruhe

    Karlsruhe, Medizinische Klinik III, 76133

  • Gemeinschaftspraxis Fur Hamatologie Und Onkologie

    Koln-Kalk, Buchforststr 14, 51103

  • Schwerpunktpraxis und Tagesklinik fur Hamatologie und Onkologie

    Kronach, Niederbronner Stabe 2, 96317

  • Praxis Dr Schwarzer

    Leipzig, 04289

  • Klinikum Lippe-Lemgo

    Minden, Rintelner Strae 85, 32657

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Klinik für Hämatologie, Onkologie und Palliativmedizin Mühlenkreiskliniken, Johannes Wesling Klinikum Minden

    Minden, 32429

  • Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers

    Moers, 47441

  • Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen

    München, Marchioninistr. 15, 81377

  • Stauferklinikum Schwaebisch Gmuend

    Mutlangen, 73557

  • Zentrum für Innere Medizin

    Mutlangen, 73557

  • Klinikum Enroll von Bergmann

    Potsdam, Charlotteustr 72, 14467

  • Studienzentrum Onkologie Ravensburg

    Ravensburg, 88212

  • Diakonie-Klinikum Schwabisch Hall

    Schwäbisch Hall, Innere Medizin III, 74523

  • Klinikum Traunstein

    Traunstein, Cuno-Niggl-Strate 3, 83278

Other trials in Germany

Italy25 sites

  • Azienda Ospedaliera Univarsitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliera Ospedali Riuniti di Bergamo

    Bergamo, 24128

  • AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna

    Bologna, 40138

  • Reparto Di Ematologia Dell'Azienda

    Brescia, Lombardy, 25133

  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

    Brescia, 25123

  • Centro Trapianti Midollo Osseo Ospedale Bnaghi

    Cagliari, 2-09126

  • A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto

    Catania, 95124

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, Florence, 50134

  • Azienda Ospedaliera Universitaria "San Martino"

    Genova, 16132

  • Ospedale San Raffaele Srl

    Milan, 20132

  • Ematologia, Policlinico di Milano

    Milan, 20122

  • Azienda Ospedaliera Di Rilievo Nazionale (AORN) 'Antonio Cardarelli'

    Naples, Naples, 80131

  • Azienda Ospedaliera Universitaria di Padova

    Padova, Veneto, 35128

  • Casa di Cura La Maddalena

    Palermo, 90146

  • AOUP, Santa Chiara Hospital

    Pisa, 56123

  • A.O. Bianchi Melacrino Morelli

    Reggio Calabria, 89133

  • Arcispedale S. Maria Nuova

    Reggio Emilia, 42121

  • Institute of Hematology- Sapienza University -Rome, Italy

    Roma, Rome, 00161

  • Policlinico S.Eugenio

    Roma, 0144

  • A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC

    Salerno, 84131

  • Laboratorio Analisi Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG, 71013

  • AOU Ospedali Riuniti Umbertio I

    Torrette Di Ancona, 60126

  • U.O Ematologia Az. ULSS9 di Treviso

    Treviso, 31100

  • Unita di Oncologia Polmonare A.o. San

    Turin, 10043

  • Universita Degli Studi Policlinico

    Udine, 33100

Other trials in Italy

Spain22 sites

  • Hospital universitario de Alava

    Alava, Jose Achotegui, 01009

  • IC0 Duran y Reynalds

    Barcelona, L´Hospitalet de Llobregat, 08908

  • Hospital Universitari Vall d'Hebron

    Barcelona, Passeig de La Vall D'Hebron 119-129, 08035

  • General San Pedro de Alcantara

    Cáceres, Avenida Pablo Naranjo Porras, 10003

  • Hospital Puerta del Mar

    Cadiz, Avenida Ana de Viya, 21, CP 11009

  • Hospital General Universitario Santa Lucia

    Cartagena (murcia), Calle Mezquita, 30202

  • University Hospital Reina Sofia

    Córdoba, Avda Menendez Pidal S/n, 14004

  • Hospital General Universitario de Elche

    Elche, CAMI de L´almassera 11, 03203

  • Hospital de Cabuenes

    Gijón, Camino de Los Prados, 395-33203

  • General de Jane

    Jaén, Avenida Ejercito Espanol 10, 23007

  • Hospital Xeral de Lugo

    Lugo, C/ Doctor Severo Ochoa S/N, 27004

  • Hospital Universitario de La Princesa

    Madrid, C/ Diego de León 62, 3a Planta, 28006

  • Hospital Universitario Virgen de la Victoria

    Málaga, Servicio de Oncologia, 29010

  • Hospital Costa Del Sol

    Marbella, Autovia A-7, Km 187, 29603

  • Ctra. Orihuela - Almoradi

    Orihuela (alicante), S/N San Bartolome, 03314

  • Hospital Universitario Central de Asturias

    Oviedo, Avenida de Roma S/n, 33011

  • Hospital Son Dureta

    Palma de Mallorca, Calle Andrea Doria 55, 07014

  • Hospital Fundacion Son Llatzer

    Palma de Mallorca, Ctra. Manacor, Km. 4, 07198

  • Hospital Universitario Nuestra Senora De Candelaria

    Santa Cruz de Tenerife, Carretera Del Rosario, 145, 38010

  • Nuestra Senora de Valme

    Seville, Avda. Bellavista, S/N, 41014

  • Hospital Arnau De Vilanova De Valencia

    Valencia, Calle San Clemente, 12, 46015

  • Hospital Clinico Universitario De Valladolid

    Valladolid, Avenida Ramon Y Cajal 3, 47005

Other trials in Spain

Belgium9 sites

  • Ziekenhuis Netwerk Antwerpen- Campus Middelheim

    Antwerp, Lindendreef 1, 02020

  • Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph

    Arlon, 6700

  • Cliniques Universitaires Saint Luc

    Brussels, Avenue Hippocrate 10, 01200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Centre hospitalier de Jolimont

    La Louvière, Rue Ferrer 159, 7100

  • CHC

    Liège, 4000

  • Clinique Saint-Pierre

    Ottignies, 1340

  • Az Nikolaas

    Sint-Niklaas, Lodewijk de Meesterstraat 5, 09100

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, Rue Du Parc 29, 4800

Other trials in Belgium

Norway4 sites

  • HF Alesund Hospital

    Ålesund, NO-6026

  • Helse Bergen HF Haukeland University Hospital

    Bergen, NO-5021

  • Vestre Viken/Baerums sjukhus

    Drammen, 3004

  • Fredrikstad Hospital

    Fredrikstad, N-1603

Other trials in Norway

Denmark3 sites

  • Aarhus Universitetshospital

    Karup, Noerrebrogade 44, 8000

  • Odense Hospital

    Odense, Kloevervanget 10, 05000

  • Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25

    Vejle, 7100

Other trials in Denmark

Sweden2 sites

  • Sunderby Hospital

    Luleå, 97180

  • University Hospital UMEA

    Umeå, 901 85

Other trials in Sweden

About this study

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

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.

Being tested
IMNOVID
Keywords
Pomalidomide, Multiple Myeloma, Relapsed, Refractory, Observational, Imnovid, Registry, Post-approval, Safety
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMNOVIDDrug

    Also called pomalidomide, CC-4047, BMS-986379

    IMNOVID (pomalidomide) as prescribed in routine clinical practice

Study groups in NCT02164955
Study groupRoleWhat they receive
Relapsed and Refractory Multiple Myeloma PatientsSingle Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
Receives: Drug: IMNOVID

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. 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

    Measured: Up to 3 years

  2. Previous Treatments

    To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).

    Measured: Approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study start26 Jun 2014
  3. Primary completion10 Oct 2022
  4. Study completion10 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
775 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02164955
Sponsor's protocol ID
CC-4047-MM-015
Status last verified
Oct 2022
First submitted
13 Jun 2014
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28504846

  • 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.

    PubMed 29945920

  • 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.

    PubMed 29802551

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Celgene at 122 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United Kingdom, Germany, Italy, Spain, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine incidence of risks as outlined in the Risk Management Plan (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02164955, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in