Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

May 31, 2023

Conditions
Multiple Myeloma
Interventions
DRUG

CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE

Patients will start induction treatment with Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. Low dose Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. Carfilzomib = 20 mg/m2 IV once daily on days 1, 2, of cycle 1 only followed by 36 mg/ m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 36 mg/ m2 IV once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Each cycle will be repeated every 28 days for a total of 9 courses. MANTEINANCE PERIOD At the end of induction phase (9 courses), maintenance phase with Carfilzomib alone IV at 36 mg/ m2 IV on days 1, 2, 15, 16 will start, until progression or intolerance. For patients who show evidence of progression during maintenance phase, the frequency of Carfilzomib can be increased to days 1, 2, 8, 9, 15, 16 at the discretion of the investigator, or the patient may be removed from the study

Trial Locations (13)

10126

SC Ematologia - A.O.U. Città della Salute e della Scienza di Torino, Torino

SSD CLINICAL TRIAL IN ONCOEMATOLOGIA E MIELOMA MULTIPLO - A.O.U. Città della Salute e della Scienza di Torino, Torino

20133

Istituto Nazionale per lo Studio e la Cura dei Tumori_UO Ematologia_Trapianto di Midollo Osseo Allogenico, Milan

28100

Divisione di Ematologia Dipartimento di Medicina Clinica e Sperimentale Università Amedeo Avogadro, Novara

40138

Policlinico S. Orsola Istituto di Ematologia e Oncologia Medica, Bologna

50134

Az.Osp. Di Careggi_Dh ematologia, Florence

60020

azienda ospedaliero-universitaria umberto I Clinica di Ematologia, Ancona

85100

IRCCS CROB UOC di Ematologia e trapianto cellule staminali Ospedale Oncologico Regionale, Rionero in Vulture

95124

Ospedale Ferrarotto_Reparto di Ematologia, Catania

Unknown

Cattedra di ematologia Università La Sapienza, Roma

Divisione di Ematologia Ospedale S. Eugenio, Roma

S.C.di Oncoematologia, Azienda Ospedaliera S. Maria di Terni, Terni

Erasmus MC, Rotterdam

All Listed Sponsors
collaborator

Fondazione EMN Italy Onlus

OTHER

lead

European Myeloma Network B.V.

NETWORK

NCT01346787 - Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients | Biotech Hunter | Biotech Hunter