Multiple Myeloma Clinical Trial
— MIROIROfficial title:
Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
| NCT number | NCT02902900 |
| Other study ID # | CC-4047-MM-018 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2015 |
| Est. completion date | May 31, 2022 |
| Verified date | June 2022 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2504 |
| Est. completion date | May 31, 2022 |
| Est. primary completion date | May 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier General | Albi Cedex | |
| France | Groupe Hospitalier Sud | Amiens Cedex 1 | |
| France | Hotel Dieu | Angers Cedex 9 | |
| France | Ch D'Arras | Arras Cedex | |
| France | Centre Hospitalier Intercommunal Robert Ballanger | Aulnay Sous Bois | |
| France | Centre Hospitalier H. Duffaut | Avignon Cedex 9 | |
| France | Centre Hospitalier Jeanne d'Arc | Bar Le Duc Cedex | |
| France | Chic Cote Basque Bayonne | Bayonne Cedex | |
| France | Hopital Nord Franche-Comte - Site de Belfort | Belfort Cedex | |
| France | Hopital Jean Minjoz | Besancon Cedex | |
| France | Centre Hospitalier General | Blois Cedex | |
| France | Hôpital Avicenne | Bobigny Cedex | |
| France | Institut Bergonie | Bordeaux Cedex | |
| France | Polyclin Bordeaux Nord Aquitaine | Bordeaux Cedex | |
| France | Ch Docteur Duchenne | Boulogne Sur Mer | |
| France | Ch de Fleyriat | Bourg En Bresse Cedex | |
| France | Ch Pierre Oudot | Bourgoin Jallieu Cedex | |
| France | Hôpital d'Instruction des Armées | Brest Armees Cedex 9 | |
| France | Hopital Augustin Morvan | Brest Cedex | |
| France | Ch de Brive La Gaillarde | Brive La Gaillarde | |
| France | Hopital Cote de Nacre | Caen Cedex 9 | |
| France | Hopital Pierre Nouveau | Cannes Cedex | |
| France | Clinique Du Parc | Castelnau Le Lez | |
| France | Hopital Prive Sevigne | Cesson Sevigne Cedex | |
| France | Médipôle de Savoie | Challes Les Eaux | |
| France | Ch William Morey | Chalon Sur Saone Cedex | |
| France | Ch de Chambery | Chambery | |
| France | Centre Hospitalier | Cholet | |
| France | Hopital Antoine Beclere | Clamart Cedex | |
| France | Chu Estaing | Clermont Ferrand | |
| France | Pole Sante Republique | Clermont Ferrand Cedex 2 | |
| France | Ch Sud Francilien | Corbeil Essonnes Cedex | |
| France | Centre Hospitalier de Creil | Creil Cedex | |
| France | Gh Henri Mondor Albert Chenevier | Creteil Cedex | |
| France | Ch de Dax | Dax Cedex | |
| France | Hopital Francois Mitterrand | Dijon | |
| France | Ch Dracenie | Draguignan | |
| France | Ch de Dunkerque | Dunkerque Cedex 1 | |
| France | Centre Hospitalier Emile Durkheim | Epinal Cedex | |
| France | Clinique Pasteur | Evreux | |
| France | Chi de Frejus Saint Raphael | Frejus Cedex | |
| France | Chi Des Alpes Du Sud | Gap Cedex | |
| France | Institut Daniel Hollard | Grenoble | |
| France | Hopital Charles Foix | Ivry Sur Seine | |
| France | Polyclinique de Blois | La Chaussee St Victor | |
| 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 Mans | Le Mans Cedex 9 | |
| France | Ch Du Docteur Schaffner | Lens Cedex | |
| France | Hopital Robert Boulin | Libourne Cedex | |
| France | Hopital Claude Huriez | Lille Cedex | |
| France | Hopital Saint Vincent | Lille Cedex | |
| France | Hopital Dupuytren | Limoges Cedex 1 | |
| France | Ch Bretagne Sud Site Lorient | Lorient Cedex | |
| France | Centre Hospitalier General | Lourdes Cedex | |
| France | Hopital Edouard Herriot | Lyon Cedex 3 | |
| France | Hopital de La Conception | Marseille Cedex 05 | |
| France | Institut J Paoli-Calmettes | Marseille Cedex 09 | |
| France | Hôpital Saint Joseph | Marseille Cedex 8 | |
| France | Centre Hospitalier de Martigues | Martigues | |
| France | Ch de Meaux | Meaux Cedex | |
| 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 | Clinique Beau Soleil | Montpellier | |
| France | Hopital Saint Eloi | Montpellier Cedex 5 | |
| 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 | Centre Antoine Lacassagne | Nice | |
| France | Hopital de L'Archet | Nice Cedex 3 | |
| France | Hopital Caremeau | Nimes Cedex 9 | |
| France | Hopital Saint Louis | Paris Cedex 10 | |
| France | Hôpital Saint Antoine | Paris Cedex 12 | |
| France | Gh Pitie Salpetriere | Paris Cedex 13 | |
| France | Gh Cochin St Vincent de Paul | Paris Cedex 14 | |
| France | Hopital Necker Enfants Malades | Paris Cedex 15 | |
| France | Polyclinique Francheville | Perigueux | |
| France | Ch de Perigueux | Perigueux Cedex | |
| France | Hopital Saint Jean | Perpignan Cedex | |
| France | Ch Lyon Sud | Pierre Benite Cedex | |
| France | Hopital La Miletrie | Poitiers Cedex | |
| France | Ch Rene Dubos | Pontoise | |
| France | CH Annecy Genevois | Pringy | |
| France | Chi de Cornouaille | Quimper Cedex | |
| France | Ch de Rambouillet | Rambouillet Cedex | |
| France | Chu Reims | Reims Cedex | |
| France | Hopital Robert Debre | Reims Cedex | |
| France | Chu Rennes - Hopital Sud | Rennes Cedex 2 | |
| France | Hopital Pontchaillou | Rennes Cedex 9 | |
| France | Ch de Roanne | Roanne | |
| France | Hopitaux Drome Nord | Romans Sur Isere Cedex | |
| France | Hopital Victor Provo | Roubaix Cedex 1 | |
| France | Centre Henri Becquerel | Rouen Cedex | |
| France | Centre Hospitalier General | Saint Germain En Laye | |
| France | Centre Rene Gauducheau | Saint Herblain Cedex | |
| France | Centre Hospitalier | Saint Malo | |
| France | Chg de Saint Quentin | Saint Quentin Cedex | |
| France | C.H. Jacques Boutard | Saint Yrieix La Perche | |
| France | Centre Hospitalier | Sens Cedex | |
| France | Hopital Yves Le Foll | St Brieuc Cedex 1 | |
| France | Centre Rene Huguenin | St Cloud | |
| France | Hôpital Nord | St Priest En Jarez | |
| France | Institut de Cancérologie de la Loire | St Priest En Jarez Cedex | |
| France | Hopital Hautepierre | Strasbourg Cedex | |
| France | Hopital Hautepierre | Strasbourg Cedex 2 | |
| France | Hopital Foch | Suresnes | |
| France | C.H.I Les Hopitaux Du Leman | Thonon Les Bains | |
| France | Hopital Sainte Musse | Toulon | |
| France | Hopital Rangueil | Toulouse Cedex 9 | |
| France | IUCT Oncopole | 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 | Ch Bretagne Atlantique de Vannes | Vannes Cedex | |
| France | Chi de La Haute Saone de Vesoul | Vesoul Cedex | |
| France | Institut Gustave Roussy | Villejuif Cedex |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
France,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Overall Response Rate (ORR) | Is defined by at least a partial response (PR) according to IMWG criteria | Up to 2 years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Adverse Events (AEs) | Number of subjects with adverse events | Up to 3 years |
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