An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice
- Conditions
- Multiple Myeloma
- Registration Number
- NCT02902900
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2504
- 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.
- Previous participation in a clinical trial with pomalidomide,
- Treatment with pomalidomide in a previous line,
- Simultaneous participation in a clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to approximately 6 months 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.
- Secondary Outcome Measures
Name Time Method Time to Progression (TTP) Up to 2 years Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.
Overall Response Rate (ORR) Up to 2 years Is defined by at least a partial response (PR) according to IMWG criteria
Duration of Response (DOR) Up to 2 years 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.
Overall Survival (OS) Up to 2 years Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.
Time to Treatment Failure (TTF) Up to 2 Years 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.
Adverse Events (AEs) Up to 3 years Number of subjects with adverse events
Trial Locations
- Locations (120)
Centre Hospitalier General
🇫🇷Saint Germain En Laye, France
Centre Hospitalier H. Duffaut
🇫🇷Avignon Cedex 9, France
Centre Hospitalier Intercommunal Robert Ballanger
🇫🇷Aulnay Sous Bois, France
Centre Hospitalier Jeanne d'Arc
🇫🇷Bar Le Duc Cedex, France
Ch Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
Ch Pierre Oudot
🇫🇷Bourgoin Jallieu Cedex, France
Chu Estaing
🇫🇷Clermont Ferrand, France
Ch Du Mans
🇫🇷Le Mans Cedex 9, France
Ch de Meaux
🇫🇷Meaux Cedex, France
Hopital Saint Jean
🇫🇷Perpignan Cedex, France
Ch D'Arras
🇫🇷Arras Cedex, France
Hopital Jean Minjoz
🇫🇷Besancon Cedex, France
Hotel Dieu
🇫🇷Angers Cedex 9, France
Groupe Hospitalier Sud
🇫🇷Amiens Cedex 1, France
Hôpital Avicenne
🇫🇷Bobigny Cedex, France
Chic Cote Basque Bayonne
🇫🇷Bayonne Cedex, France
Hopital Nord Franche-Comte - Site de Belfort
🇫🇷Belfort Cedex, France
Institut Bergonie
🇫🇷Bordeaux Cedex, France
Ch de Fleyriat
🇫🇷Bourg En Bresse Cedex, France
Polyclin Bordeaux Nord Aquitaine
🇫🇷Bordeaux Cedex, France
Hôpital d'Instruction des Armées
🇫🇷Brest Armees Cedex 9, France
Hopital Augustin Morvan
🇫🇷Brest Cedex, France
Hopital Pierre Nouveau
🇫🇷Cannes Cedex, France
Hopital Cote de Nacre
🇫🇷Caen Cedex 9, France
Ch de Brive La Gaillarde
🇫🇷Brive La Gaillarde, France
Clinique Du Parc
🇫🇷Castelnau Le Lez, France
Médipôle de Savoie
🇫🇷Challes Les Eaux, France
Ch William Morey
🇫🇷Chalon Sur Saone Cedex, France
Ch de Chambery
🇫🇷Chambery, France
Centre Hospitalier
🇫🇷Sens Cedex, France
Centre Hospitalier de Creil
🇫🇷Creil Cedex, France
Hopital Antoine Beclere
🇫🇷Clamart Cedex, France
Pole Sante Republique
🇫🇷Clermont Ferrand Cedex 2, France
Ch Sud Francilien
🇫🇷Corbeil Essonnes Cedex, France
Gh Henri Mondor Albert Chenevier
🇫🇷Creteil Cedex, France
Ch de Dax
🇫🇷Dax Cedex, France
Hopital Francois Mitterrand
🇫🇷Dijon, France
Ch de Dunkerque
🇫🇷Dunkerque Cedex 1, France
Centre Hospitalier Emile Durkheim
🇫🇷Epinal Cedex, France
Clinique Pasteur
🇫🇷Evreux, France
Ch Dracenie
🇫🇷Draguignan, France
Chi de Frejus Saint Raphael
🇫🇷Frejus Cedex, France
Chi Des Alpes Du Sud
🇫🇷Gap Cedex, France
Institut Daniel Hollard
🇫🇷Grenoble, France
Polyclinique de Blois
🇫🇷La Chaussee St Victor, France
Hopital Charles Foix
🇫🇷Ivry Sur Seine, France
Hopital Robert Boulin
🇫🇷Libourne Cedex, France
Ch Dptal Les Oudairies
🇫🇷La Roche Sur Yon Cedex 9, France
Centre Hospitalier de La Rochelle
🇫🇷La Rochelle, France
Hopital Albert Michallon
🇫🇷La Tronche, France
Ch Andre Mignot
🇫🇷Le Chesnay Cedex, France
Hopital Louis Pasteur
🇫🇷Le Coudray Cedex, France
Clinique Victor Hugo
🇫🇷Le Mans Cedex 2, France
Ch Du Docteur Schaffner
🇫🇷Lens Cedex, France
Hopital Saint Vincent
🇫🇷Lille Cedex, France
Hopital Claude Huriez
🇫🇷Lille Cedex, France
Ch Bretagne Sud Site Lorient
🇫🇷Lorient Cedex, France
Hopital Dupuytren
🇫🇷Limoges Cedex 1, France
Hopital Edouard Herriot
🇫🇷Lyon Cedex 3, France
Centre Hospitalier de Martigues
🇫🇷Martigues, France
Hopital de La Conception
🇫🇷Marseille Cedex 05, France
Institut J Paoli-Calmettes
🇫🇷Marseille Cedex 09, France
Hôpital Saint Joseph
🇫🇷Marseille Cedex 8, France
Hopital Marc Jacquet
🇫🇷Melun, France
Hopital Belle Isle
🇫🇷Metz Cedex 01, France
HOPITAL Metz Mercy
🇫🇷Metz Cedex 03, France
Hopital Jacques Monod
🇫🇷Montivilliers, France
Hopital Saint Eloi
🇫🇷Montpellier Cedex 5, France
Clinique Beau Soleil
🇫🇷Montpellier, France
Ch Des Pays de Morlaix
🇫🇷Morlaix Cedex, France
Ch Mulhouse
🇫🇷Mulhouse Cedex 1, France
Hopital Hotel Dieu Et Hme
🇫🇷Nantes Cedex 1, France
Centre Catherine de Sienne
🇫🇷Nantes Cedex 2, France
Ch Pierre Beregovoy
🇫🇷Nevers Cedex, France
Hopital Saint Louis
🇫🇷Paris Cedex 10, France
Hopital de L'Archet
🇫🇷Nice Cedex 3, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Gh Pitie Salpetriere
🇫🇷Paris Cedex 13, France
Hopital Caremeau
🇫🇷Nimes Cedex 9, France
Hôpital Saint Antoine
🇫🇷Paris Cedex 12, France
Hopital Necker Enfants Malades
🇫🇷Paris Cedex 15, France
Gh Cochin St Vincent de Paul
🇫🇷Paris Cedex 14, France
Ch de Perigueux
🇫🇷Perigueux Cedex, France
Polyclinique Francheville
🇫🇷Perigueux, France
Hopital La Miletrie
🇫🇷Poitiers Cedex, France
Hopital Robert Debre
🇫🇷Reims Cedex, France
Ch Rene Dubos
🇫🇷Pontoise, France
CH Annecy Genevois
🇫🇷Pringy, France
Chi de Cornouaille
🇫🇷Quimper Cedex, France
Ch Lyon Sud
🇫🇷Pierre Benite Cedex, France
Hopital Pontchaillou
🇫🇷Rennes Cedex 9, France
Ch de Rambouillet
🇫🇷Rambouillet Cedex, France
Ch de Roanne
🇫🇷Roanne, France
Chu Reims
🇫🇷Reims Cedex, France
Chu Rennes - Hopital Sud
🇫🇷Rennes Cedex 2, France
Hopitaux Drome Nord
🇫🇷Romans Sur Isere Cedex, France
Chg de Saint Quentin
🇫🇷Saint Quentin Cedex, France
Hopital Victor Provo
🇫🇷Roubaix Cedex 1, France
Centre Henri Becquerel
🇫🇷Rouen Cedex, France
Centre Rene Gauducheau
🇫🇷Saint Herblain Cedex, France
Centre Rene Huguenin
🇫🇷St Cloud, France
Hopital Yves Le Foll
🇫🇷St Brieuc Cedex 1, France
C.H. Jacques Boutard
🇫🇷Saint Yrieix La Perche, France
Hopital Foch
🇫🇷Suresnes, France
Institut de Cancérologie de la Loire
🇫🇷St Priest En Jarez Cedex, France
Hopital Sainte Musse
🇫🇷Toulon, France
Hôpital Nord
🇫🇷St Priest En Jarez, France
C.H.I Les Hopitaux Du Leman
🇫🇷Thonon Les Bains, France
Hopital Hautepierre
🇫🇷Strasbourg Cedex, France
IUCT Oncopole
🇫🇷Toulouse Cedex 9, France
Hopital Rangueil
🇫🇷Toulouse Cedex 9, France
Hopital Bretonneau
🇫🇷Tours, France
Hopital Des Hauts Clos
🇫🇷Troyes Cedex, France
Centre Hospitalier de Valence
🇫🇷Valence Cedex 9, France
Ch de Valenciennes
🇫🇷Valenciennes Cedex, France
Hopitaux de Brabois
🇫🇷Vandoeuvre Les Nancy Cedex, France
Chi de La Haute Saone de Vesoul
🇫🇷Vesoul Cedex, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Ch Bretagne Atlantique de Vannes
🇫🇷Vannes Cedex, France
Hopital Prive Sevigne
🇫🇷Cesson Sevigne Cedex, France