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COMPLETED
NCT01053949
PHASE2

IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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