Clinical trial NCT02902900: An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice
Official title: Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Pomalidomide
Efficacy
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 2504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 6 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Time to Progression (TTP)
timeFrame: Up to 2 years
measure: Time to Treatment Failure (TTF)
timeFrame: Up to 2 Years
measure: Adverse Events (AEs)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Albi Cedex
country: France
facility: Centre Hospitalier General
city: Amiens Cedex 1
country: France
facility: Groupe Hospitalier Sud
city: Angers Cedex 9
country: France
facility: Hotel Dieu
city: Arras Cedex
country: France
facility: Ch D'Arras
city: Aulnay Sous Bois
country: France
facility: Centre Hospitalier Intercommunal Robert Ballanger
city: Avignon Cedex 9
country: France
facility: Centre Hospitalier H. Duffaut
city: Bar Le Duc Cedex
country: France
facility: Centre Hospitalier Jeanne d'Arc
city: Bayonne Cedex
country: France
facility: Chic Cote Basque Bayonne
city: Belfort Cedex
country: France
facility: Hopital Nord Franche-Comte - Site de Belfort
city: Besancon Cedex
country: France
facility: Hopital Jean Minjoz
city: Blois Cedex
country: France
facility: Centre Hospitalier General
city: Bobigny Cedex
country: France
facility: Hôpital Avicenne
city: Bordeaux Cedex
country: France
facility: Institut Bergonie
city: Bordeaux Cedex
country: France
facility: Polyclin Bordeaux Nord Aquitaine
city: Boulogne Sur Mer
country: France
facility: Ch Docteur Duchenne
city: Bourg En Bresse Cedex
country: France
facility: Ch de Fleyriat
city: Bourgoin Jallieu Cedex
country: France
facility: Ch Pierre Oudot
city: Brest Armees Cedex 9
country: France
facility: Hôpital d'Instruction des Armées
city: Brest Cedex
country: France
facility: Hopital Augustin Morvan
city: Brive La Gaillarde
country: France
facility: Ch de Brive La Gaillarde
city: Caen Cedex 9
country: France
facility: Hopital Cote de Nacre
city: Cannes Cedex
country: France
facility: Hopital Pierre Nouveau
city: Castelnau Le Lez
country: France
facility: Clinique Du Parc
city: Cesson Sevigne Cedex
country: France
facility: Hopital Prive Sevigne
city: Challes Les Eaux
country: France
facility: Médipôle de Savoie
city: Chalon Sur Saone Cedex
country: France
facility: Ch William Morey
city: Chambery
country: France
facility: Ch de Chambery
city: Cholet
country: France
facility: Centre Hospitalier
city: Clamart Cedex
country: France
facility: Hopital Antoine Beclere
city: Clermont Ferrand Cedex 2
country: France
facility: Pole Sante Republique
city: Clermont Ferrand
country: France
facility: Chu Estaing
city: Corbeil Essonnes Cedex
country: France
facility: Ch Sud Francilien
city: Creil Cedex
country: France
facility: Centre Hospitalier de Creil
city: Creteil Cedex
country: France
facility: Gh Henri Mondor Albert Chenevier
city: Dax Cedex
country: France
facility: Ch de Dax
city: Dijon
country: France
facility: Hopital Francois Mitterrand
city: Draguignan
country: France
facility: Ch Dracenie
city: Dunkerque Cedex 1
country: France
facility: Ch de Dunkerque
city: Epinal Cedex
country: France
facility: Centre Hospitalier Emile Durkheim
city: Evreux
country: France
facility: Clinique Pasteur
city: Frejus Cedex
country: France
facility: Chi de Frejus Saint Raphael
city: Gap Cedex
country: France
facility: Chi Des Alpes Du Sud
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: Ivry Sur Seine
country: France
facility: Hopital Charles Foix
city: La Chaussee St Victor
country: France
facility: Polyclinique de Blois
city: La Roche Sur Yon Cedex 9
country: France
facility: Ch Dptal Les Oudairies
city: La Rochelle
country: France
facility: Centre Hospitalier de La Rochelle
city: La Tronche
country: France
facility: Hopital Albert Michallon
city: Le Chesnay Cedex
country: France
facility: Ch Andre Mignot
city: Le Coudray Cedex
country: France
facility: Hopital Louis Pasteur
city: Le Mans Cedex 2
country: France
facility: Clinique Victor Hugo
city: Le Mans Cedex 9
country: France
facility: Ch Du Mans
city: Lens Cedex
country: France
facility: Ch Du Docteur Schaffner
city: Libourne Cedex
country: France
facility: Hopital Robert Boulin
city: Lille Cedex
country: France
facility: Hopital Saint Vincent
city: Lille Cedex
country: France
facility: Hopital Claude Huriez
city: Limoges Cedex 1
country: France
facility: Hopital Dupuytren
city: Lorient Cedex
country: France
facility: Ch Bretagne Sud Site Lorient
city: Lourdes Cedex
country: France
facility: Centre Hospitalier General
city: Lyon Cedex 3
country: France
facility: Hopital Edouard Herriot
city: Marseille Cedex 05
country: France
facility: Hopital de La Conception
city: Marseille Cedex 09
country: France
facility: Institut J Paoli-Calmettes
city: Marseille Cedex 8
country: France
facility: Hôpital Saint Joseph
city: Martigues
country: France
facility: Centre Hospitalier de Martigues
city: Meaux Cedex
country: France
facility: Ch de Meaux
city: Melun
country: France
facility: Hopital Marc Jacquet
city: Metz Cedex 01
country: France
facility: Hopital Belle Isle
city: Metz Cedex 03
country: France
facility: HOPITAL Metz Mercy
city: Montivilliers
country: France
facility: Hopital Jacques Monod
city: Montpellier Cedex 5
country: France
facility: Hopital Saint Eloi
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Morlaix Cedex
country: France
facility: Ch Des Pays de Morlaix
city: Mulhouse Cedex 1
country: France
facility: Ch Mulhouse
city: Nantes Cedex 1
country: France
facility: Hopital Hotel Dieu Et Hme
city: Nantes Cedex 2
country: France
facility: Centre Catherine de Sienne
city: Nevers Cedex
country: France
facility: Ch Pierre Beregovoy
city: Nice Cedex 3
country: France
facility: Hopital de L'Archet
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes Cedex 9
country: France
facility: Hopital Caremeau
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
city: Paris Cedex 12
country: France
facility: Hôpital Saint Antoine
city: Paris Cedex 13
country: France
facility: Gh Pitie Salpetriere
city: Paris Cedex 14
country: France
facility: Gh Cochin St Vincent de Paul
city: Paris Cedex 15
country: France
facility: Hopital Necker Enfants Malades
city: Perigueux Cedex
country: France
facility: Ch de Perigueux
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Perpignan Cedex
country: France
facility: Hopital Saint Jean
city: Pierre Benite Cedex
country: France
facility: Ch Lyon Sud
city: Poitiers Cedex
country: France
facility: Hopital La Miletrie
city: Pontoise
country: France
facility: Ch Rene Dubos
city: Pringy
country: France
facility: CH Annecy Genevois
city: Quimper Cedex
country: France
facility: Chi de Cornouaille
city: Rambouillet Cedex
country: France
facility: Ch de Rambouillet
city: Reims Cedex
country: France
facility: Chu Reims
city: Reims Cedex
country: France
facility: Hopital Robert Debre
city: Rennes Cedex 2
country: France
facility: Chu Rennes - Hopital Sud
city: Rennes Cedex 9
country: France
facility: Hopital Pontchaillou
city: Roanne
country: France
facility: Ch de Roanne
city: Romans Sur Isere Cedex
country: France
facility: Hopitaux Drome Nord
city: Roubaix Cedex 1
country: France
facility: Hopital Victor Provo
city: Rouen Cedex
country: France
facility: Centre Henri Becquerel
city: Saint Germain En Laye
country: France
facility: Centre Hospitalier General
city: Saint Herblain Cedex
country: France
facility: Centre Rene Gauducheau
city: Saint Malo
country: France
facility: Centre Hospitalier
city: Saint Quentin Cedex
country: France
facility: Chg de Saint Quentin
city: Saint Yrieix La Perche
country: France
facility: C.H. Jacques Boutard
city: Sens Cedex
country: France
facility: Centre Hospitalier
city: St Brieuc Cedex 1
country: France
facility: Hopital Yves Le Foll
city: St Cloud
country: France
facility: Centre Rene Huguenin
city: St Priest En Jarez Cedex
country: France
facility: Institut de Cancérologie de la Loire
city: St Priest En Jarez
country: France
facility: Hôpital Nord
city: Strasbourg Cedex 2
country: France
facility: Hopital Hautepierre
city: Strasbourg Cedex
country: France
facility: Hopital Hautepierre
city: Suresnes
country: France
facility: Hopital Foch
city: Thonon Les Bains
country: France
facility: C.H.I Les Hopitaux Du Leman
city: Toulon
country: France
facility: Hopital Sainte Musse
city: Toulouse Cedex 9
country: France
facility: Hopital Rangueil
city: Toulouse Cedex 9
country: France
facility: IUCT Oncopole
city: Tours
country: France
facility: Hopital Bretonneau
city: Troyes Cedex
country: France
facility: Hopital Des Hauts Clos
city: Valence Cedex 9
country: France
facility: Centre Hospitalier de Valence
city: Valenciennes Cedex
country: France
facility: Ch de Valenciennes
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Hopitaux de Brabois
city: Vannes Cedex
country: France
facility: Ch Bretagne Atlantique de Vannes
city: Vesoul Cedex
country: France
facility: Chi de La Haute Saone de Vesoul
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
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