A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of optimal dose of BT062 (Phase I part)
The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
6 months
Yes
Kenneth C Anderson, MD
Study Director
Dana-Farber Cancer Institute
United States: Food and Drug Administration
983
NCT01638936
July 2012
November 2014
Name | Location |
---|---|
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Mayo Clinic | Jacksonville, Florida 32224 |
City of Hope | Duarte, California 91010 |
University of Texas Health Science Center | San Antonio, Texas 78284 |