Phase II Trial Of Zolinza With Velcade
The Multiple Myeloma Research Consortium (MMRC) announced a Phase IIb study of Zolinza®, an oral histone deacetylase (HDAC) inhibitor, in combination with Velcade® for Injection, a proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. The study is open for enrollment. This international, multicenter, open-label clinical trial is sponsored by Merck & Co. and is part of the VANTAGE (Vorinostat Clinical Trials in Hematologic and Solid Malignancies) program.
The trial will enroll 142 patients from more than 60 clinical centers including the following MMRC Member Institutions: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, Hackensack University Medical Center, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, and University Health Network (Princess Margaret Hospital). Patients must be refractory to Velcade taken alone or in combination with other anti-myeloma therapies and have been exposed to prior immunomodulatory therapies, such as Revlimid® (lenalidomide, Celgene Corporation) or Thalomid® (thalidomide, Celgene Corporation). The study will assess the objective response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination.
"Vorinostat is one of a promising class of drugs that may offer a new treatment option for patients with multiple myeloma, particularly when combined with bortezomib," said Kenneth Anderson, MD, a member of the MMRC Steering Committee and Chief of the Division of Hematologic Neoplasia and Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.
For more information about this and other clinical trials, please visit http://www.myelomatrials.org or call 866-603-MMCT (6628).
About Zolinza Zolinza is approved in the United States for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. In addition to the Phase II-b study, Merck has also initiated a Phase III, global, randomized, double-blind, placebo-controlled, multi-center trial (Vantage 088) investigating Zolinza in combination with Velcade in patients with relapsed multiple myeloma after 1-3 prior anti-myeloma regimen. The Phase III trial will enroll 742 patients at more than 200 centers. The study will compare progression-free survival in patients taking Velcade in combination with either Zolinza or placebo. The study is open for enrollment.
The trial will enroll 142 patients from more than 60 clinical centers including the following MMRC Member Institutions: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, Hackensack University Medical Center, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, and University Health Network (Princess Margaret Hospital). Patients must be refractory to Velcade taken alone or in combination with other anti-myeloma therapies and have been exposed to prior immunomodulatory therapies, such as Revlimid® (lenalidomide, Celgene Corporation) or Thalomid® (thalidomide, Celgene Corporation). The study will assess the objective response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination.
"Vorinostat is one of a promising class of drugs that may offer a new treatment option for patients with multiple myeloma, particularly when combined with bortezomib," said Kenneth Anderson, MD, a member of the MMRC Steering Committee and Chief of the Division of Hematologic Neoplasia and Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.
For more information about this and other clinical trials, please visit http://www.myelomatrials.org or call 866-603-MMCT (6628).
About Zolinza Zolinza is approved in the United States for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. In addition to the Phase II-b study, Merck has also initiated a Phase III, global, randomized, double-blind, placebo-controlled, multi-center trial (Vantage 088) investigating Zolinza in combination with Velcade in patients with relapsed multiple myeloma after 1-3 prior anti-myeloma regimen. The Phase III trial will enroll 742 patients at more than 200 centers. The study will compare progression-free survival in patients taking Velcade in combination with either Zolinza or placebo. The study is open for enrollment.
posted by gwg at 2:19 PM
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