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Brief Title: BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
Official Title: A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
Study ID: NCT01638936
Brief Summary: The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Detailed Description: BT062 is an antibody-drug conjugate designed to bind and destroy Myeloma cells. The study drug is being given in multiple doses with standard Multiple Myeloma treatments, lenalidomide and dexamethasone, to test how well the treatments are tolerated and work together. This study is a dose escalation study with the purpose to find out the highest dose of BT062 that a subject can tolerate in combination with lenalidomide and dexamethasone.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Mayo Clinic, Jacksonville, Florida, United States
Memorial Healthcare System, Pembroke Pines, Florida, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
The University of Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Mount Sinai Medical Center, New York, New York, United States
University of Texas Health Science Center, San Antonio, Texas, United States
Name: Kenneth C Anderson, MD
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_DIRECTOR