BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01638936

Run by

Biotest Pharmaceuticals Corporation

People needed

64

Starts

2012-07-03

Expected to finish

2018-10-30

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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