Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Multiple Myeloma in Relapse
Interventions
DRUG

Vorinostat

"Vorinostat 100 mg/d p.o., on day 1-4, 8-11, and 15-18 /28 day treatment cycle in combination with BDD.~The dose level of Vorinostat will be escalated in each new cohort:~if no dose limiting toxicity (DLT) has been observed in the previous dose level in 3 patient, the second cohort of 3 new patients will be treated with Vorinostat 200 mg/d p.o. and the third cohort will be given Vorinostat with 300 mg/d p.o."

DRUG

Bortezomib

1.3mg/m2 (days 1,8,15)/28 day treatment cycle, i.v., for max. 6 treatment cycles

DRUG

Doxorubicin

18mg/m2 i.v. (days 1 and 8)/ 28 day treatment cycle, max. 6 treatment cycles

DRUG

Dexamethasone

40mg abs. p.o. (days 1,8,15,22) 1st treatment cycle, 20mg abs. p.o.(days 1,8,15,22) 2-6 treatment cycles

Trial Locations (1)

79106

University Medical Center Freiburg, Freiburg im Breisgau

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Janssen-Cilag Ltd.

INDUSTRY

lead

University Hospital Freiburg

OTHER

NCT01394354 - Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM) | Biotech Hunter | Biotech Hunter