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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma

• Study Type: Observational
• Enrollment (Actual): 2504

Contacts and Locations

Study Locations

• France
  • Albi Cedex, France, 81013
    • Centre Hospitalier General
  • Amiens Cedex 1, France, 80054
    • Groupe Hospitalier Sud
  • Angers Cedex 9, France, 49933
    • Hotel Dieu
  • Arras Cedex, France, 62022
    • CH d'Arras
  • Aulnay Sous Bois, France, 93602
    • Centre Hospitalier Intercommunal Robert Ballanger
  • Avignon Cedex 9, France, 84000
    • Centre Hospitalier H. Duffaut
  • Bar Le Duc Cedex, France, 55012
    • Centre Hospitalier Jeanne d'Arc
  • Bayonne Cedex, France, 64109
    • Chic Cote Basque Bayonne
  • Belfort Cedex, France, 90016
    • Hopital Nord Franche-Comte - Site de Belfort
  • Besancon Cedex, France, 25030
    • Hopital Jean Minjoz
  • Blois Cedex, France, 41016
    • Centre Hospitalier General
  • Bobigny Cedex, France, 93000
    • Hopital Avicenne
  • Bordeaux Cedex, France, 33076
    • Institut Bergonie
  • Bordeaux Cedex, France, 33077
    • Polyclin Bordeaux Nord Aquitaine
  • Boulogne Sur Mer, France, 62321
    • Ch Docteur Duchenne
  • Bourg En Bresse Cedex, France, 01012
    • Ch de Fleyriat
  • Bourgoin Jallieu Cedex, France, 38302
    • CH Pierre Oudot
  • Brest Armees Cedex 9, France, 29240
    • Hopital D'Instruction Des Armees
  • Brest Cedex, France, 29609
    • Hopital Augustin Morvan
  • Brive La Gaillarde, France, 19100
    • CH de Brive la Gaillarde
  • Caen Cedex 9, France, 14033
    • Hôpital Côte De Nacre
  • Cannes Cedex, France, 06401
    • Hopital Pierre Nouveau
  • Castelnau Le Lez, France, 34170
    • Clinique du Parc
  • Cesson Sevigne Cedex, France, 35576
    • Hôpital Privé Sévigné
  • Challes Les Eaux, France, 73190
    • Médipôle de Savoie
  • Chalon Sur Saone Cedex, France, 71100
    • CH William Morey
  • Chambery, France, 73000
    • CH de Chambery
  • Cholet, France, 49325
    • Centre Hospitalier
  • Clamart Cedex, France, 92141
    • Hopital Antoine Beclere
  • Clermont Ferrand, France, 63000
    • CHU Estaing
  • Clermont Ferrand Cedex 2, France, 63050
    • Pole Santé République
  • Corbeil Essonnes Cedex, France, 91106
    • CH Sud Francilien
  • Creil Cedex, France, 60109
    • Centre Hospitalier de Creil
  • Creteil Cedex, France, 94010
    • Gh Henri Mondor Albert Chenevier
  • Dax Cedex, France, 40107
    • CH de Dax
  • Dijon, France, 21000
    • Hôpital François Mitterrand
  • Draguignan, France, 83300
    • Ch Dracenie
  • Dunkerque Cedex 1, France, 59385
    • CH de Dunkerque
  • Epinal Cedex, France, 88021
    • Centre Hospitalier Emile Durkheim
  • Evreux, France, 27000
    • Clinique Pasteur
  • Frejus Cedex, France, 83608
    • Chi de Frejus Saint Raphael
  • Gap Cedex, France, 05007
    • Chi Des Alpes Du Sud
  • Grenoble, France, 38000
    • Institut Daniel Hollard
  • Ivry Sur Seine, France, 94200
    • Hôpital Charles Foix
  • La Chaussee St Victor, France, 41260
    • Polyclinique De Blois
  • La Roche Sur Yon Cedex 9, France, 85925
    • Ch Dptal Les Oudairies
  • La Rochelle, France, 17019
    • Centre Hospitalier de La Rochelle
  • La Tronche, France, 38700
    • Hôpital Albert Michallon
  • Le Chesnay Cedex, France, 78157
    • Ch Andre Mignot
  • Le Coudray Cedex, France, 28630
    • Hopital Louis Pasteur
  • Le Mans Cedex 2, France, 72015
    • Clinique Victor Hugo
  • Le Mans Cedex 9, France, 72037
    • CH du Mans
  • Lens Cedex, France, 62307
    • Ch Du Docteur Schaffner
  • Libourne Cedex, France, 33505
    • Hôpital Robert Boulin
  • Lille Cedex, France, 59037
    • Hôpital Claude Huriez
  • Lille Cedex, France, 59020
    • Hôpital Saint Vincent
  • Limoges Cedex 1, France, 87042
    • Hôpital Dupuytren
  • Lorient Cedex, France, 56322
    • Ch Bretagne Sud Site Lorient
  • Lourdes Cedex, France, 65115
    • Centre Hospitalier General
  • Lyon Cedex 3, France, 69437
    • Hopital Edouard Herriot
  • Marseille Cedex 05, France, 13385
    • Hôpital de la Conception
  • Marseille Cedex 09, France, 13273
    • Institut J Paoli-Calmettes
  • Marseille Cedex 8, France, 13285
    • Hôpital Saint Joseph
  • Martigues, France, 13698
    • Centre Hospitalier de Martigues
  • Meaux Cedex, France, 77104
    • CH de Meaux
  • Melun, France, 77011
    • Hopital Marc Jacquet
  • Metz Cedex 01, France, 57045
    • Hôpital Belle Isle
  • Metz Cedex 03, France, 57085
    • HOPITAL Metz Mercy
  • Montivilliers, France, 76290
    • Hopital Jacques Monod
  • Montpellier, France, 34070
    • Clinique Beau Soleil
  • Montpellier Cedex 5, France, 34295
    • Hopital Saint Eloi
  • Morlaix Cedex, France, 29672
    • CH des Pays de Morlaix
  • Mulhouse Cedex 1, France, 68070
    • CH Mulhouse
  • Nantes Cedex 1, France, 44093
    • Hopital Hotel Dieu Et Hme
  • Nantes Cedex 2, France, 44277
    • Centre Catherine de Sienne
  • Nevers Cedex, France, 58033
    • CH Pierre Bérégovoy
  • Nice, France, 06100
    • Centre Antoine Lacassagne
  • Nice Cedex 3, France, 06202
    • Hopital de l'Archet
  • Nimes Cedex 9, France, 30029
    • Hopital Caremeau
  • Paris Cedex 10, France, 75475
    • Hôpital Saint Louis
  • Paris Cedex 12, France, 75571
    • Hôpital Saint Antoine
  • Paris Cedex 13, France, 75651
    • GH Pitié Salpêtrière
  • Paris Cedex 14, France, 75679
    • Gh Cochin St Vincent de Paul
  • Paris Cedex 15, France, 75743
    • Hopital Necker Enfants Malades
  • Perigueux, France, 24000
    • Polyclinique Francheville
  • Perigueux Cedex, France, 24019
    • CH de Périgueux
  • Perpignan Cedex, France, 66046
    • Hopital Saint Jean
  • Pierre Benite Cedex, France, 69495
    • CH Lyon sud
  • Poitiers Cedex, France, 86021
    • Hopital La Miletrie
  • Pontoise, France, 95300
    • CH René Dubos
  • Pringy, France, 74374
    • Ch Annecy Genevois
  • Quimper Cedex, France, 29107
    • CHI de Cornouaille
  • Rambouillet Cedex, France, 78514
    • CH de Rambouillet
  • Reims Cedex, France, 51092
    • CHU Reims
  • Reims Cedex, France, 51092
    • Hopital Robert Debre
  • Rennes Cedex 2, France, 35203
    • CHU Rennes - Hôpital sud
  • Rennes Cedex 9, France, 35033
    • Hopital Pontchaillou
  • Roanne, France, 42300
    • CH de Roanne
  • Romans Sur Isere Cedex, France, 26102
    • Hopitaux Drome Nord
  • Roubaix Cedex 1, France, 59100
    • Hôpital Victor Provo
  • Rouen Cedex, France, 76038
    • Centre Henri Becquerel
  • Saint Germain En Laye, France, 78100
    • Centre Hospitalier General
  • Saint Herblain Cedex, France, 44805
    • Centre Rene Gauducheau
  • Saint Malo, France, 35403
    • Centre Hospitalier
  • Saint Quentin Cedex, France, 02321
    • Chg de Saint Quentin
  • Saint Yrieix La Perche, France, 87500
    • C.H. Jacques Boutard
  • Sens Cedex, France, 89106
    • Centre Hospitalier
  • St Brieuc Cedex 1, France, 22027
    • Hôpital Yves Le Foll
  • St Cloud, France, 92210
    • Centre René Huguenin
  • St Priest En Jarez, France, 42270
    • Hopital Nord
  • St Priest En Jarez Cedex, France, 42270
    • Institut de Cancérologie de la Loire
  • Strasbourg Cedex, France, 67091
    • Hôpital Hautepierre
  • Strasbourg Cedex 2, France, 67098
    • Hôpital Hautepierre
  • Suresnes, France, 92150
    • Hopital Foch
  • Thonon Les Bains, France, 74203
    • C.H.I Les Hopitaux Du Leman
  • Toulon, France, 83100
    • Hôpital Sainte Musse
  • Toulouse Cedex 9, France, 31059
    • Hopital Rangueil
  • Toulouse Cedex 9, France, 31059
    • IUCT Oncopole
  • Tours, France, 37044
    • Hôpital Bretonneau
  • Troyes Cedex, France, 10003
    • Hopital des Hauts Clos
  • Valence Cedex 9, France, 26953
    • Centre Hospitalier de Valence
  • Valenciennes Cedex, France, 59322
    • CH de Valenciennes
  • Vandoeuvre Les Nancy Cedex, France, 54511
    • Hôpitaux de Brabois
  • Vannes Cedex, France, 56017
    • Ch Bretagne Atlantique de Vannes
  • Vesoul Cedex, France, 70014
    • Chi de La Haute Saone de Vesoul
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Imnovid; Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Is defined by at least a partial response (PR) according to IMWG criteria	Up to 2 years
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.	Up to 2 years
Overall Survival (OS)	Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.	Up to 2 years
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.	Up to 2 years
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.	Up to 2 Years
Adverse Events (AEs)	Number of subjects with adverse events	Up to 3 years

Collaborators and Investigators

• Sponsor: Celgene

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Expanded Access for CC-4047

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pomalidomide; Multiple Myeloma; Efficacy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CC-4047-MM-018