Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

Tracking Information
First Submitted Date ICMJE	October 22, 2009
First Posted Date ICMJE	October 26, 2009
Last Update Posted Date	January 31, 2017
Study Start Date ICMJE	August 2010
Actual Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 23, 2009)	Dose limiting toxicities [ Time Frame: On a weekly basis for the duration of the study ]; Maximum tolerated dose [ Time Frame: About every 2 months for the duration of the study ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01001442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 23, 2009)	Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results [ Time Frame: On a weekly basis for the duration of the study ]; Pharmacokinetics as assessed by measuring intact BT062 conjugate and free cytotoxic agent [ Time Frame: On a weekly basis for the duration of the study ]; Anti-tumor activity assessed by measuring response according to the defined multiple myeloma response criteria [ Time Frame: On a monthly basis for the duration of the study ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title ICMJE	A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
Brief Summary	This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Multiple Myeloma
Intervention ICMJE	Drug: BT062; intravenous administration
Study Arms	Experimental: BT062; Intervention: Drug: BT062
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 30, 2017)	35
Original Estimated Enrollment ICMJE; (submitted: October 23, 2009)	80
Actual Study Completion Date	March 2016
Actual Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Diagnosis of active multiple myeloma according to the International Myeloma Working Group diagnostic criteria; Relapsed or relapsed/refractory multiple myeloma; Previous treatment with both an immunomodulator and a proteosome inhibitor therapy; Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤ 2; Ability to understand and willingness to sign a written informed consent document; Ability to adhere with the study visit schedule and other protocol procedures; Life expectancy of ≥ 12 weeks; Normal organ and marrow function 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 AEs due to agents administered more than 3 weeks earlier; Treatment with another investigational agent during the study or within 4 weeks before day 1; Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies); Antineoplastic therapy with biological agents within 2 weeks before day 1; Known HAHAs, HACAs, or HAMAs in response to previous MAb therapy; Previous treatment with BT062; Malignancy within 3 years before day 1, other than the trial indication multiple myeloma and excluding treated non-melanoma skin cancer, superficial bladder cancer and carcinoma in-situ of the cervix; Severe diseases of skin, colon, esophagus, or eye within 1 year before day 1, as judged by the Investigator; 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 which, in the judgment of the investigator, would make the subject inappropriate for enrollment into this study; Acute or relevant abnormalities in electrocardiogram (ECG), as judged by the Investigator. These abnormalities can be defined as recent myocardial infarction, uncontrolled cardiac arrhythmias and/or pronounced disturbances of the electrical conduction system of the heart.; Significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg), uncontrolled cardiac arrhythmias, grade 3 (Lown Criteria) or greater cardiac toxicity from prior chemotherapy; History of clinically significant drug or alcohol abuse; Unwillingness or inability to adhere to the requirements of the study; Concomitant therapy with corticosteroids (except as indicated in low dose for other medical conditions such as inhaled steroid for asthma, topical use, or as premedication for administration of certain medications (including BT062) or blood products and for treatment of infusion reactions if needed); Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study; Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he or she are included in the study; Breast-feeding; Unwillingness to use an effective contraceptive method during the study and at least 3 months after administration of study drug - unless subject is naturally infertile. (Acceptable contraceptive methods include oral or injectable contraceptives, intrauterine devices (IUD), double-barrier method, contraceptive patch, surgical sterilization, or condoms).; Positive serum or urine pregnancy test
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01001442
Other Study ID Numbers ICMJE	975
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Biotest Pharmaceuticals Corporation
Study Sponsor ICMJE	Biotest Pharmaceuticals Corporation
Collaborators ICMJE	Biotest
Investigators ICMJE	Study Director: Kenneth C. Anderson, MD Dana-Farber Cancer Institute
PRS Account	Biotest Pharmaceuticals Corporation
Verification Date	August 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP