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Multiple MyelomaMIROIRNCT02902900

An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice

An observational study of Multiple Myeloma, run by Celgene at 126 sites in France.

Completed

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

Official record
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Trial summary

This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry. This study will add to the registry. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
2,504 participants
Where
126 sitesFrance
Study dates
1 Apr 2015to 31 May 2022
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: The MIROIR study focuses on multiple myeloma patients treated with pomalidomide in France whose treatment was initiated between October 1, 2014, and September 30, 2019. Patients having initiated pomalidomide outside of this period or having received pomalidomide in a previous treatment line will not be included.

Who may be able to join

  • Adult patient (age ≥ 18 yrs),
  • Diagnosed with multiple myeloma (measurable or not),
  • In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2019,
  • Patient already included in the Imnovid registry,
  • Having received oral and written information about the study, and having given their consent to participate.

Who cannot join

  • Previous participation in a clinical trial with pomalidomide,
  • Treatment with pomalidomide in a previous line,
  • Simultaneous participation in a clinical trial.

Trial locations and contacts

126 sites in 1 country.

126 sites in 1 country

France126 sites

  • Centre Hospitalier General

    Albi, 81013

  • Groupe Hospitalier Sud

    Amiens, 80054

  • Hotel Dieu

    Angers, 49933

  • Ch D'Arras

    Arras, 62022

  • Centre Hospitalier Intercommunal Robert Ballanger

    Aulnay-sous-Bois, 93602

  • Centre Hospitalier H. Duffaut

    Avignon, 84000

  • Centre Hospitalier Jeanne d'Arc

    Bar-le-Duc, 55012

  • Chic Cote Basque Bayonne

    Bayonne, 64109

  • Hopital Nord Franche-Comte - Site de Belfort

    Belfort, 90016

  • Hopital Jean Minjoz

    Besançon, 25030

  • Centre Hospitalier General

    Blois, 41016

  • Hôpital Avicenne

    Bobigny, 93000

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclin Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • Ch Docteur Duchenne

    Boulogne-sur-Mer, 62321

  • Ch de Fleyriat

    Bourg-en-Bresse, 01012

  • Ch Pierre Oudot

    Bourgoin, 38302

  • Hopital Augustin Morvan

    Brest, 29609

  • Hôpital d'Instruction des Armées

    Brest Armees Cedex 9, 29240

  • Ch de Brive La Gaillarde

    Brive-la-Gaillarde, 19100

  • Hopital Cote de Nacre

    Caen, 14033

  • Hopital Pierre Nouveau

    Cannes, 06401

  • Clinique Du Parc

    Castelnau-le-Lez, 34170

  • Hopital Prive Sevigne

    Cesson-Sévigné, 35576

  • Médipôle de Savoie

    Challes-les-Eaux, 73190

  • Ch William Morey

    Chalon-sur-Saône, 71100

  • Ch de Chambery

    Chambéry, 73000

  • Centre Hospitalier

    Cholet, 49325

  • Hopital Antoine Beclere

    Clamart, 92141

  • Chu Estaing

    Clermont-Ferrand, 63000

  • Pole Sante Republique

    Clermont-Ferrand, 63050

  • Ch Sud Francilien

    Corbeil-Essonnes, 91106

  • Centre Hospitalier de Creil

    Creil, 60109

  • Gh Henri Mondor Albert Chenevier

    Créteil, 94010

  • Ch de Dax

    Dax, 40107

  • Hopital Francois Mitterrand

    Dijon, 21000

  • Ch Dracenie

    Draguignan, 83300

  • Ch de Dunkerque

    Dunkirk, 59385

  • Centre Hospitalier Emile Durkheim

    Épinal, 88021

  • Clinique Pasteur

    Évreux, 27000

  • Chi de Frejus Saint Raphael

    Fréjus, 83608

  • Chi Des Alpes Du Sud

    Gap, 05007

  • Institut Daniel Hollard

    Grenoble, 38000

  • Hopital Charles Foix

    Ivry-sur-Seine, 94200

  • Polyclinique de Blois

    La Chaussée-Saint-Victor, 41260

  • Ch Dptal Les Oudairies

    La Roche-sur-Yon, 85925

  • Centre Hospitalier de La Rochelle

    La Rochelle, 17019

  • Hopital Albert Michallon

    La Tronche, 38700

  • Ch Andre Mignot

    Le Chesnay, 78157

  • Hopital Louis Pasteur

    Le Coudray, 28630

  • Clinique Victor Hugo

    Le Mans, 72015

  • Ch Du Mans

    Le Mans, 72037

  • Ch Du Docteur Schaffner

    Lens, 62307

  • Hopital Robert Boulin

    Libourne, 33505

  • Hopital Saint Vincent

    Lille, 59020

  • Hopital Claude Huriez

    Lille, 59037

  • Hopital Dupuytren

    Limoges, 87042

  • Ch Bretagne Sud Site Lorient

    Lorient, 56322

  • Centre Hospitalier General

    Lourdes, 65115

  • Hopital Edouard Herriot

    Lyon, 69437

  • Institut J Paoli-Calmettes

    Marseille, 13273

  • Hôpital Saint Joseph

    Marseille, 13285

  • Hopital de La Conception

    Marseille, 13385

  • Centre Hospitalier de Martigues

    Martigues, 13698

  • Ch de Meaux

    Meaux, 77104

  • Hopital Marc Jacquet

    Melun, 77011

  • Hopital Belle Isle

    Metz, 57045

  • HOPITAL Metz Mercy

    Metz, 57085

  • Hopital Jacques Monod

    Montivilliers, 76290

  • Clinique Beau Soleil

    Montpellier, 34070

  • Hopital Saint Eloi

    Montpellier, 34295

  • Ch Des Pays de Morlaix

    Morlaix, 29672

  • Ch Mulhouse

    Mulhouse, 68070

  • Hopital Hotel Dieu Et Hme

    Nantes, 44093

  • Centre Catherine de Sienne

    Nantes, 44277

  • Ch Pierre Beregovoy

    Nevers, 58033

  • Centre Antoine Lacassagne

    Nice, 06100

  • Hopital de L'Archet

    Nice, 06202

  • Hopital Caremeau

    Nîmes, 30029

  • Hopital Saint Louis

    Paris, 75475

  • Hôpital Saint Antoine

    Paris, 75571

  • Gh Pitie Salpetriere

    Paris, 75651

  • Gh Cochin St Vincent de Paul

    Paris, 75679

  • Hopital Necker Enfants Malades

    Paris, 75743

  • Polyclinique Francheville

    Périgueux, 24000

  • Ch de Perigueux

    Périgueux, 24019

  • Hopital Saint Jean

    Perpignan, 66046

  • Ch Lyon Sud

    Pierre-Bénite, 69495

  • Hopital La Miletrie

    Poitiers, 86021

  • Ch Rene Dubos

    Pontoise, 95300

  • CH Annecy Genevois

    Pringy, 74374

  • Chi de Cornouaille

    Quimper, 29107

  • Ch de Rambouillet

    Rambouillet, 78514

  • Chu Reims

    Reims, 51092

  • Hopital Robert Debre

    Reims, 51092

  • Hopital Pontchaillou

    Rennes, 35033

  • Chu Rennes - Hopital Sud

    Rennes, 35203

  • Ch de Roanne

    Roanne, 42300

  • Hopitaux Drome Nord

    Romans-sur-Isère, 26102

  • Hopital Victor Provo

    Roubaix, 59100

  • Centre Henri Becquerel

    Rouen, 76038

  • Hopital Yves Le Foll

    Saint-Brieuc, 22027

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Hospitalier General

    Saint-Germain-en-Laye, 78100

  • Centre Rene Gauducheau

    Saint-Herblain, 44805

  • Hôpital Nord

    Saint-Priest-en-Jarez, 42270

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Chg de Saint Quentin

    Saint-Quentin, 02321

  • C.H. Jacques Boutard

    Saint-Yrieix-la-Perche, 87500

  • Centre Hospitalier

    Sens, 89106

  • Centre Hospitalier

    St-Malo, 35403

  • Hopital Hautepierre

    Strasbourg, 67091

  • Hopital Hautepierre

    Strasbourg, 67098

  • Hopital Foch

    Suresnes, 92150

  • C.H.I Les Hopitaux Du Leman

    Thonon-les-Bains, 74203

  • Hopital Sainte Musse

    Toulon, 83100

  • Hopital Rangueil

    Toulouse, 31059

  • IUCT Oncopole

    Toulouse, 31059

  • Hopital Bretonneau

    Tours, 37044

  • Hopital Des Hauts Clos

    Troyes, 10003

  • Centre Hospitalier de Valence

    Valence, 26953

  • Ch de Valenciennes

    Valenciennes, 59322

  • Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Ch Bretagne Atlantique de Vannes

    Vannes, 56017

  • Chi de La Haute Saone de Vesoul

    Vesoul, 70014

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

Keywords
Multiple Myeloma, Pomalidomide, Efficacy
Medical subject headings
Multiple Myeloma

What participants receive

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

Study groups in NCT02902900
Study groupRoleWhat they receive
ImnovidPatients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice

What is being measured

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

  1. Progression Free Survival (PFS)

    Is defined as the time between the date of treatment initiation with pomalidomide and the date of the first progression according to the International Myeloma Working Group (IMWG) criteria or death whatever the cause.

    Measured: Up to approximately 6 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    Is defined by at least a partial response (PR) according to IMWG criteria

    Measured: Up to 2 years

  2. Duration of Response (DOR)

    Is calculated for responders with at least partial response (PR) as the time between the first observation of response and the time of the first event such as disease progression or death due to progression.

    Measured: Up to 2 years

  3. Overall Survival (OS)

    Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.

    Measured: Up to 2 years

  4. Time to Progression (TTP)

    Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.

    Measured: Up to 2 years

  5. Time to Treatment Failure (TTF)

    Is defined as the duration between the date of the start of pomalidomide treatment and the first progression according to IMWG criteria, second cancer, toxicity requiring treatment discontinuation or death of the patient.

    Measured: Up to 2 Years

  6. Adverse Events (AEs)

    Number of subjects with adverse events

    Measured: Up to 3 years

Timeline

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

  1. First posted16 Sep 2016 (estimated)
  2. Study start1 Apr 2015
  3. Primary completion31 May 2022
  4. Study completion31 May 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
Retrospective
Enrolment
2,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02902900
Sponsor's protocol ID
CC-4047-MM-018
Acronym
MIROIR
Status last verified
Jun 2022
First submitted
13 Sep 2016
Last updated
27 Jun 2022
Results posted
No
Data monitoring committee
No

Publications

  • Waldschmidt JM, Simon A, Wider D, Muller SJ, Follo M, Ihorst G, Decker S, Lorenz J, Chatterjee M, Azab AK, Duyster J, Wasch R, Engelhardt M. CXCL12 and CXCR7 are relevant targets to reverse cell adhesion-mediated drug resistance in multiple myeloma. Br J Haematol. 2017 Oct;179(1):36-49. doi: 10.1111/bjh.14807. Epub 2017 Jul 2.

    PubMed 28670693

  • 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

  • Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

    PubMed 30282798

  • Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

    PubMed 30792190

  • Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

    PubMed 30773308

  • Li Y, Wang X, Liu L, Zhang C, Gomez D, Reyes J, Palmisano M, Zhou S. An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Apr;8(3):346-354. doi: 10.1002/cpdd.470. Epub 2018 May 10.

    PubMed 29746728

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Celgene at 126 sites in France.

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 5 inclusion and 3 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in France. 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?

Progression Free Survival (PFS) (time frame: Up to approximately 6 months). 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 NCT02902900, which also lists 6 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 27 Jun 2022.

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