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IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma
Sponsor: University Hospital, Lille
Summary
The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in relapse and refractory MM patients who are progressive and did not achieve at least a partial response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily treated characterized with adverse prognostic and that are in desperate need of novel therapeutics.
Official title: A Multicenter Randomized Open Label Phase II Study of Pomalidomide and Dexamethasone in Relapse and Refractory Multiple Myeloma Patients Who Are Progressive and Did Not Achieve at Least a Partial Response to Bortezomib and Lenalidomide
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2009-10
Completion Date
2015-04
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Pomalidomide
Pomalidomide 4 mg continuous daily oral route on 21 days per 28 days cycle. The proposed dose of dexamethasone is considered standard, 40mg/day once a week.
Pomalidomide
Pomalidomide 4 mg continuous daily oral route on 28 days of a 28 days cycle The proposed dose of dexamethasone is considered standard, 40mg/day once a week.
Locations (19)
CHRU-Hôpital Sud, avenue Laennec,
Amiens, France
Hématologie, Hôpital Avicenne
Bobigny, France
Hématologie, CHU, avenue G.Clemenceau
Caen, France
Hématologie Clinique, CHU, Hôpital d'Enfants
Dijon, France
Hématologie, CHRU, Hôpital A.Michallon
Grenoble, France
Service des Maladies du Sang, CHRU
Lille, France
Hôpital Edouard HERRIOT
Lyon, France
Hématologie, Institut Paoli Calmette
Marseille, France
Hématologie, CHRU, Hôpitaux de Brabois
Nancy, France
Maladies du Sang, CHRU, Hôtel Dieu
Nantes, France
Service Immuno-Hématologie, Hôpital Saint-Louis
Paris, France
Maladies du Sang, CHU - Hôpital St Antoine
Paris, France
Service des Maladies du Sang, Hôpital Haut-Levèque
Pessac, France
Service d'Hématologie, Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Hématologie Clinique, Hôpital Robert Debré, CHU Reims
Reims, France
Hôpital PONTCHAILLOU, CHU de RENNES
Rennes, France
Médecine Interne, CHRU, Hôpital Sud
Rennes, France
Hématologie, CHRU, Hôpital Purpan
Toulouse, France
Onco-Hématologie, CHRU- Hôpital Bretonneau
Tours, France