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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imnovid | Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier General | Albi | 81013 | France | |||
| Groupe Hospitalier Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28670693 | Background | 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. | |
| 29802551 |
| Label | URL |
|---|---|
| Expanded Access for CC-4047 | View source |
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| 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 |
| 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 |
| 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. |
| 30282798 | Background | 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. |
| 30792190 | Background | 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. |
| 30773308 | Background | 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. |
| 29746728 | Background | 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. |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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