BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Drug: BT062 , intravenous administration
- Registration Number
- NCT01638936
- Lead Sponsor
- Biotest Pharmaceuticals Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
- Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to day 1 or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier
- Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lives (t½) prior to first dose, whichever time period is longer
- Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
- Treatment with another investigational drug during the study or within 3 weeks before day 1 or within 5 drug half-live (t½) prior to first dose, whichever time period is longer
- Treatment with BT062 in previous studies
- Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
- Malignancy within 3 years before day 1, other than the trial indication multiple myeloma and excluding treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in-situ of the cervix and prostate carcinoma ≤ Gleason Grade 6 with stable prostate specific antigen (PSA) levels
- Subjects with plasma cell leukemia (PCL)
- Subjects with deep vein thrombosis (DVT) and Pulmonary embolism (PE) within 3 months prior to day 1 treatment
- Severe infections necessitating use of antibiotics / antivirals during the screening period
- Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease
- Acute or relevant abnormalities in electrocardiogram (ECG)
- Significant cardiac disease
- Pregnant or breast-feeding
- Positive serum or urine pregnancy test
- Hypersensitivity to the active substance or to any of the excipients for study drug BT062, or history of severe allergic or anaphylactic reaction to therapeutic proteins (e.g. reaction to vaccination or to biological therapy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BT062 BT062 , intravenous administration BT062 administered intravenously on days 1, 8 and 15 of each 28-day cycle, and lenalidomide or pomalidomide and dexamethasone administered orally to subjects with relapsed or relapsed/refractory MM
- Primary Outcome Measures
Name Time Method Determination of optimal dose of BT062 (Phase I part) 6 months 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) 18 months Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone or pomalidomide/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 skeletal survey will be performed.
- Secondary Outcome Measures
Name Time Method Assessment of Time To Event end points 24 months 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.
Pharmacokinetics of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone 24 months Pharmacokinetic parameters will be assessed from plasma by measuring intact BT062 and free maytansinoid (DM4)
Qualitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone 24 months 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
Quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone 24 months 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
Trial Locations
- Locations (10)
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
City of Hope
🇺🇸Duarte, California, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Memorial Healthcare System
🇺🇸Pembroke Pines, Florida, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States