BT062 in Combination With Lenalidomide/Dexamethasone in Patients With Multiple Myeloma
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.
Drug: BT062 , intravenous administration
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Determination of optimal dose of BT062 (Phase I part) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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).
- Evaluation of response (Phase IIa part) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and sketetal survey will be performed.
- Qualitative and quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
- Pharmacokinetics (Cmax, half-life, AUC) of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ] [ Designated as safety issue: No ]Pharmacokinetic parameters will be assessed from plasma by measuring intact BT062 and free maytansinoid (DM4)
- Assessment of Time To Event end points [ Time Frame: 24 months ] [ Designated as safety issue: No ]Based on the response evaluation, the following Time To Event end points will be evaluated: Time To Progression, Progression Free Survival, Time To Next Treatment, Duration Of Response, Overall survival.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Drug: BT062 , intravenous administration
Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638936
|Contact: Shailesh Chavan, MDfirstname.lastname@example.org|
|Contact: Pankaj Patel, PhD||561-989-5577||PaPatel@biotestpharma.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|The University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|United States, New Jersey|
|Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|United States, Texas|
|University of Texas Health Science Center||Recruiting|
|San Antonio, Texas, United States, 78229|
|Study Director:||Kenneth C Anderson, MD||Dana-Farber Cancer Institute|