Multiple Myeloma in Relapse Clinical Trial
Official title:
Safety of Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma, A Phase I/II Study, Short Title: VBDD
Primary objective of the study is the determination of the maximum tolerated dose (MTD) of
Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and
Dexamethasone (D).
Secondary objectives are:
Assessment of safety and tolerability of VBDD; efficacy data of VBDD.
A first cohort of three patients will be treated at the starting dose level of Vorinostat
100 mg/d, on day 1-4, 8-11, and 15-18 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 and
the third cohort will be given Vorinostat with 300 mg/d.
Bortezomib will be administered intravenously (i.v.) 1.3mg/m2 d1, 8, 15. Doxorubicin will be
administered i.v. with a total dose of 18 mg/m2 per cycle (9 mg/m2, d1 and 8).
Dexamethasone will be administered per os (p.o.) with 40mg (first cycle) and 20mg (all other
subsequent cycles) on d1, 8, 15, 22.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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