T WO INVE S TIGATIONAL S TUDIE S :
NOW ENROLLING
Vorinostat Clinical Trials in Hematologic and Solid Malignancies
VANTAGE 088
VANTAGE 095
Multiple Myeloma
Multiple Myeloma
A Phase 3, International, Multicenter, Randomized,
A Phase 2b, International, Multicenter, Open-Label
Double-Blind Study of the HDAC Inhibitor Vorinostat
Study of the HDAC Inhibitor Vorinostat in Combination
or Placebo in Combination With Bortezomib in
With Bortezomib in Patients With Relapsed or
Patients With Multiple Myeloma (NCT00773747)
Refractory Multiple Myeloma (NCT00773838)
VANTAGE 088 study schema
VANTAGE 095 study schema
Established diagnosis of multiple myeloma
Established diagnosis of multiple myeloma
based on myeloma diagnostic criteria
based on myeloma diagnostic criteria
Randomized
Open label
Oral vorinostat
Oral placebo
Oral vorinostat
I.V. bortezomib
I.V. bortezomib
I.V. bortezomib
Study duration: approximately 33 months.
Study duration: up to 18 months.
Primary End Point
Primary End Point
· Progression-free survival
· Response rate
Key Secondary End Point
Key Secondary End Point
· Tolerability
· Tolerability
Study Population
Study Population
· Patients aged 18 years
· Patients aged 18 years
· Established diagnosis of multiple myeloma
· Established diagnosis of multiple myeloma
· Have received at least 1 but no more than
· Relapsed after or refractory to at least 2 prior
3 prior antimyeloma regimens and have
antimyeloma regimens
progressive disease after the most recent
· Refractory to bortezomib
treatment regimen
· Exposure to prior IMiD (thalidomide or lenalidomide)
· Have adequate organ function
· Have adequate organ function
To learn more, please visit msdcancertrials.com.
Please see clinicaltrials.gov for more complete information.
HDAC=histone deacetylase.
Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA.
All rights reserved. 5-11 ZLZ-2010-W-1332005-W

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