NCT02244125 - A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial | Biotech Hunter

Enrollment

100

Participants

Timeline

Start Date

April 14, 2014

Primary Completion Date

January 31, 2017

Study Completion Date

May 29, 2023

Conditions

Multiple MyelomaFirst Relapse

Interventions

DRUG

PCD

"STUDY TREATMENT PHASE: All patients~* 4x 28 days cycles of PCD~\[Pomalidomide: 4mg/day oral route on 21 days per cycle\]~\[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle\]~\[Dexamethasone: 40mg/day oral route on days 1, 2, 3, 4 and 15, 16, 17, 18 per cycle\]~CONSOLIDATION PHASE: depends on previous IFM/DFCI 2009's arm:~Arm A:~* Melphalan 200mg/m2 followed by Autologous Transplantation~* 2x 28 days cycles of PCD, three months post transplantation~Arm B:~* 5x 28 days cycles of PCD~\[Pomalidomide: 4mg/day oral route on 21 days per cycle\]~\[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle\]~\[Dexamethasone: 40mg/day oral route on days 1, 8, 15, 22 per cycle\]~MAINTENANCE PHASE: All patients~\- Until progression/relapse or discontinuation for any other reason~\[Pomalidomide: 4mg/day oral route on 21 days per cycle\]~\[Dexamethasone: 20mg/day oral route on days 1, 8, 15, 22 per cycle\]"

PROCEDURE

Autologous transplantation (ASCT)

"Arm A:~•Melphalan 200mg/m2 followed by Autologous Transplantation"

Trial Locations (30)

13273

Institut Paoli Calmette, Marseille

14033

Institut d'Hématologie de Basse Normandie - IHBN, Caen

21000

CHRU Dijon, Dijon

22027

Centre Hospitalier Yves Le Foll, Saint-Brieuc

29609

ICH - Hôpital A. Morvan, Brest

30029

CHU Carémeau, Nîmes

31059

Institut Universitaire du Cancer Toulouse-Oncopôle (IUCT-O), Toulouse

33604

CHRU Hôpital Haut Lévêque, Pessac

35033

CHRU Hopital Pontchaillou, Rennes

37044

CHRU Hopital Bretonneau, Tours

38043

Chru Grenoble, Grenoble

44093

CHU de Nantes, Nantes

54511

CHRU Hopitaux de Brabois, Vandœuvre-lès-Nancy

59037

CHRU - Hôpital Claude Huriez, Lille

59385

Centre Hospitalier Général, Dunkirk

63003

Chu Estaing, Clermont-Ferrand

64109

Centre Hospitalier de la côte Basque, Bayonne

68100

Hopital Emile Muller, Mulhouse

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72000

Clinique Victor Hugo, Le Mans

74374

Centre Hospitalier Annecy Genevois, Pringy

75012

CHRU Hopital Saint Antoine, Paris

76038

Centre Henri Becquerel, Rouen

80054

CHRU Hopital Sud, Amiens

85925

Centre Hospitalier départemental de Vendée, La Roche-sur-Yon

87042

CHU de Limoges, Limoges

92210

Centre René Huguenin, Saint-Cloud

93009

Hôpital Avicenne, Bobigny

94010

CHU Henri Mondor, Créteil

750005

Institut Curie, Paris