IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma

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.

Conditions

• Multiple Myeloma

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.

Sponsors & Collaborators

• Celgene

  collaborator INDUSTRY

• University Hospital, Lille

  lead OTHER

Principal Investigators

• Bruno ROYER, MD PhD · CHRU-Hôpital Sud d'Amiens-AMIENS

• Philippe RODON, MD PhD · Centre Hospitalier de Blois -BLOIS

• Sabine BRECHIGNAC, MD PhD · Hôpital Avicenne-Bobigny- PARIS

• Gerard MARIT, MD PhD · Hôpital Haut-Levèque de Pessac-BORDEAUX

• Christian BERTHOU, MD PhD · Service d'Hématologie Clinique, CHU Morvan, BREST

• Margaret MACRO, MD PhD · Hématologie, CHU, CAEN

• Denis CAILLOT, MD PhD · Hématologie Clinique, CHU, Hôpital d'Enfants, DIJON

• Brigitte PEGOURIE, MD PhD · Hématologie, CHRU, Hôpital A.Michallon, GRENOBLE

• Catherine TRAULLE, MD PhD · Service d'Hématologie, Centre Hospitalier Lyon Sud, PIERRE BENIT

• Anne Marie STOPPA, MD PhD · Hématologie, Institut Paoli Calmette, MARSEILLE

• Cyrille HULIN, MD PhD · Hématologie, CHRU, Hôpitaux de Brabois, VANDOEUVRE

• Philippe MOREAU, MD PhD · Maladies du Sang, CHRU, Hôtel Dieu, NANTES

• Jean-Gabriel FUZIBET, MD PhD · Médecine Interne, Oncologie, Hôpital de l'Archet 1, NICE

• Bernard GROSBOIS, MD PhD · Médecine Interne, CHRU, Hôpital Sud, RENNES

• Brigitte KOLB, MD PfD · Hématologie Clinique, Hôpital Robert Debré, CHU REIMS

• Laurent GARDERET, MD PhD · Maladies du Sang, CHU - Hôpital St Antoine, PARIS

• Jean-Paul FERMAND, MD PhD · Service Immuno-Hématologie, Hôpital Saint-Louis, PARIS

• Michel ATTAL, MD PhD · Hématologie, CHRU, Hôpital Purpan, TOULOUSE

• Lofti BENBOUBKER, MD PhD · Onco-Hématologie, CHRU- Hôpital Bretonneau, TOURS

• Xavier Leleu, MD PhD · Service des maladies du sang, CHRU de Lille

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2014-04-30

Completion

2015-04-30

Countries

• France

Study Locations