This trial is active, not recruiting.

Condition multiple myeloma
Treatment bt062 , intravenous administration
Phase phase 1/phase 2
Target SDC1
Sponsor Biotest Pharmaceuticals Corporation
Collaborator Biotest
Start date July 2012
End date July 2016
Trial size 64 participants
Trial identifier NCT01638936, 983


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Primary Outcomes

Determination of optimal dose of BT062 (Phase I part)
time frame: 6 months
Evaluation of response (Phase IIa part)
time frame: 18 months

Secondary Outcomes

Qualitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
time frame: 24 months
Pharmacokinetics of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
time frame: 24 months
Assessment of Time To Event end points
time frame: 24 months
Quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Diagnosis of active Multiple Myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria - Relapsed or relapsed/refractory progressive Multiple Myeloma - Subjects who failed at least one prior therapy (BT062/Len/dex) - Subjects who failed at least two prior therapy (BT062/Pom/dex) - Subjects age ≥18 years - Life expectancy of ≥12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤2 - Normal organ and bone marrow - Signed written informed consent in accordance with federal, local, and institutional guidelines - Subjects must agree to follow all Guidelines from REVLIMID REMS Program or POMALYST REMS - Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods Exclusion Criteria: - 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)

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Biotest Pharmaceuticals Corporation.
Location data was received from the National Cancer Institute and was last updated in July 2016.