Phase 1b Study of Carfilzomib Administered Once Weekly in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma Save

Date Added
September 8th, 2015
PRO Number
Pro00046355
Researcher
Amarendra Neppalli
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with multiple myeloma. The investigational drug in this study is carfilzomib. The purpose of this study is to find out more about carfilzomib in people with multiple myeloma, a cancer that affects how normal blood cells grow and work. Participants can expect to be in this study for about 2.5 years (30 months), including a maximum of about 1.5 years (18 months) of study drug administration as well as about 1 year of follow-up visits.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Multicenter Phase 1/2b Study of the Bruton?s Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis™) in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma Save

Date Added
February 11th, 2014
PRO Number
Pro00031755
Researcher
Amarendra Neppalli
Keywords
Cancer, Men's Health, Women's Health
Summary

This study if for patients that have been diagnosed with muliple myeloma. Pharmacyclics, Inc. (the Sponsor) is studying an investigational new drug called ibrutinib. Ibrutinib is a type of drug called a ?kinase inhibitor?. ?Kinases? are proteins inside cells that help cells live and grow. The specific kinase inhibited or ?blocked? by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing.

The study has two parts:
? Phase 1 tests different doses of ibrutinib and carfilzomib together to study what dose to use in Phase 2b
? Phase 2b will study the effects of the treatment. All subjects will receive carfilzomib, only half of the subjects will receive ibrutinib, to test if there is a benefit to adding ibrutinib to carfilzomib treatment
Participation in this study will last approximately two years. This will include coming to the study center for treatment and follow-up after the study treatment ends.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

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