An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice
MIROIR
Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
1 other identifier
observational
2,504
1 country
126
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJune 27, 2022
June 1, 2022
7.2 years
September 13, 2016
June 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to approximately 6 months
Secondary Outcomes (6)
Overall Response Rate (ORR)
Up to 2 years
Duration of Response (DOR)
Up to 2 years
Overall Survival (OS)
Up to 2 years
Time to Progression (TTP)
Up to 2 years
Time to Treatment Failure (TTF)
Up to 2 Years
- +1 more secondary outcomes
Study Arms (1)
Imnovid
Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Previous participation in a clinical trial with pomalidomide,
- Treatment with pomalidomide in a previous line,
- Simultaneous participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (126)
Centre Hospitalier General
Albi, 81013, France
Groupe Hospitalier Sud
Amiens, 80054, France
Hotel Dieu
Angers, 49933, France
Ch D'Arras
Arras, 62022, France
Centre Hospitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois, 93602, France
Centre Hospitalier H. Duffaut
Avignon, 84000, France
Centre Hospitalier Jeanne d'Arc
Bar-le-Duc, 55012, France
Chic Cote Basque Bayonne
Bayonne, 64109, France
Hopital Nord Franche-Comte - Site de Belfort
Belfort, 90016, France
Hopital Jean Minjoz
Besançon, 25030, France
Centre Hospitalier General
Blois, 41016, France
Hôpital Avicenne
Bobigny, 93000, France
Institut Bergonie
Bordeaux, 33076, France
Polyclin Bordeaux Nord Aquitaine
Bordeaux, 33077, France
Ch Docteur Duchenne
Boulogne-sur-Mer, 62321, France
Ch de Fleyriat
Bourg-en-Bresse, 01012, France
Ch Pierre Oudot
Bourgoin, 38302, France
Hopital Augustin Morvan
Brest, 29609, France
Hôpital d'Instruction des Armées
Brest Armees Cedex 9, 29240, France
Ch de Brive La Gaillarde
Brive-la-Gaillarde, 19100, France
Hopital Cote de Nacre
Caen, 14033, France
Hopital Pierre Nouveau
Cannes, 06401, France
Clinique Du Parc
Castelnau-le-Lez, 34170, France
Hopital Prive Sevigne
Cesson-Sévigné, 35576, France
Médipôle de Savoie
Challes-les-Eaux, 73190, France
Ch William Morey
Chalon-sur-Saône, 71100, France
Ch de Chambery
Chambéry, 73000, France
Centre Hospitalier
Cholet, 49325, France
Hopital Antoine Beclere
Clamart, 92141, France
Chu Estaing
Clermont-Ferrand, 63000, France
Pole Sante Republique
Clermont-Ferrand, 63050, France
Ch Sud Francilien
Corbeil-Essonnes, 91106, France
Centre Hospitalier de Creil
Creil, 60109, France
Gh Henri Mondor Albert Chenevier
Créteil, 94010, France
Ch de Dax
Dax, 40107, France
Hopital Francois Mitterrand
Dijon, 21000, France
Ch Dracenie
Draguignan, 83300, France
Ch de Dunkerque
Dunkirk, 59385, France
Centre Hospitalier Emile Durkheim
Épinal, 88021, France
Clinique Pasteur
Évreux, 27000, France
Chi de Frejus Saint Raphael
Fréjus, 83608, France
Chi Des Alpes Du Sud
Gap, 05007, France
Institut Daniel Hollard
Grenoble, 38000, France
Hopital Charles Foix
Ivry-sur-Seine, 94200, France
Polyclinique de Blois
La Chaussée-Saint-Victor, 41260, France
Ch Dptal Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Hospitalier de La Rochelle
La Rochelle, 17019, France
Hopital Albert Michallon
La Tronche, 38700, France
Ch Andre Mignot
Le Chesnay, 78157, France
Hopital Louis Pasteur
Le Coudray, 28630, France
Clinique Victor Hugo
Le Mans, 72015, France
Ch Du Mans
Le Mans, 72037, France
Ch Du Docteur Schaffner
Lens, 62307, France
Hopital Robert Boulin
Libourne, 33505, France
Hopital Saint Vincent
Lille, 59020, France
Hopital Claude Huriez
Lille, 59037, France
Hopital Dupuytren
Limoges, 87042, France
Ch Bretagne Sud Site Lorient
Lorient, 56322, France
Centre Hospitalier General
Lourdes, 65115, France
Hopital Edouard Herriot
Lyon, 69437, France
Institut J Paoli-Calmettes
Marseille, 13273, France
Hôpital Saint Joseph
Marseille, 13285, France
Hopital de La Conception
Marseille, 13385, France
Centre Hospitalier de Martigues
Martigues, 13698, France
Ch de Meaux
Meaux, 77104, France
Hopital Marc Jacquet
Melun, 77011, France
Hopital Belle Isle
Metz, 57045, France
HOPITAL Metz Mercy
Metz, 57085, France
Hopital Jacques Monod
Montivilliers, 76290, France
Clinique Beau Soleil
Montpellier, 34070, France
Hopital Saint Eloi
Montpellier, 34295, France
Ch Des Pays de Morlaix
Morlaix, 29672, France
Ch Mulhouse
Mulhouse, 68070, France
Hopital Hotel Dieu Et Hme
Nantes, 44093, France
Centre Catherine de Sienne
Nantes, 44277, France
Ch Pierre Beregovoy
Nevers, 58033, France
Centre Antoine Lacassagne
Nice, 06100, France
Hopital de L'Archet
Nice, 06202, France
Hopital Caremeau
Nîmes, 30029, France
Hopital Saint Louis
Paris, 75475, France
Hôpital Saint Antoine
Paris, 75571, France
Gh Pitie Salpetriere
Paris, 75651, France
Gh Cochin St Vincent de Paul
Paris, 75679, France
Hopital Necker Enfants Malades
Paris, 75743, France
Hopital Saint Jean
Perpignan, 66046, France
Polyclinique Francheville
Périgueux, 24000, France
Ch de Perigueux
Périgueux, 24019, France
Ch Lyon Sud
Pierre-Bénite, 69495, France
Hopital La Miletrie
Poitiers, 86021, France
Ch Rene Dubos
Pontoise, 95300, France
CH Annecy Genevois
Pringy, 74374, France
Chi de Cornouaille
Quimper, 29107, France
Ch de Rambouillet
Rambouillet, 78514, France
Chu Reims
Reims, 51092, France
Hopital Robert Debre
Reims, 51092, France
Hopital Pontchaillou
Rennes, 35033, France
Chu Rennes - Hopital Sud
Rennes, 35203, France
Ch de Roanne
Roanne, 42300, France
Hopitaux Drome Nord
Romans-sur-Isère, 26102, France
Hopital Victor Provo
Roubaix, 59100, France
Centre Henri Becquerel
Rouen, 76038, France
Hopital Yves Le Foll
Saint-Brieuc, 22027, France
Centre Rene Huguenin
Saint-Cloud, 92210, France
Centre Hospitalier General
Saint-Germain-en-Laye, 78100, France
Centre Rene Gauducheau
Saint-Herblain, 44805, France
Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, France
Chg de Saint Quentin
Saint-Quentin, 02321, France
C.H. Jacques Boutard
Saint-Yrieix-la-Perche, 87500, France
Centre Hospitalier
Sens, 89106, France
Centre Hospitalier
St-Malo, 35403, France
Hopital Hautepierre
Strasbourg, 67091, France
Hopital Hautepierre
Strasbourg, 67098, France
Hopital Foch
Suresnes, 92150, France
C.H.I Les Hopitaux Du Leman
Thonon-les-Bains, 74203, France
Hopital Sainte Musse
Toulon, 83100, France
Hopital Rangueil
Toulouse, 31059, France
IUCT Oncopole
Toulouse, 31059, France
Hopital Bretonneau
Tours, 37044, France
Hopital Des Hauts Clos
Troyes, 10003, France
Centre Hospitalier de Valence
Valence, 26953, France
Ch de Valenciennes
Valenciennes, 59322, France
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Ch Bretagne Atlantique de Vannes
Vannes, 56017, France
Chi de La Haute Saone de Vesoul
Vesoul, 70014, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (6)
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.
PMID: 28670693BACKGROUNDDinner 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.
PMID: 29802551BACKGROUNDGarderet 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.
PMID: 30282798BACKGROUNDMark 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.
PMID: 30792190BACKGROUNDAilawadhi 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.
PMID: 30773308BACKGROUNDLi 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.
PMID: 29746728BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 16, 2016
Study Start
April 1, 2015
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
June 27, 2022
Record last verified: 2022-06