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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001442
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: BT062 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BT062 Drug: BT062
intravenous administration

Primary Outcome Measures :
  1. Dose limiting toxicities [ Time Frame: On a weekly basis for the duration of the study ]
  2. Maximum tolerated dose [ Time Frame: About every 2 months for the duration of the study ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetics as assessed by measuring intact BT062 conjugate and free cytotoxic agent [ Time Frame: On a weekly basis for the duration of the study ]
  3. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001442

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
The Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Biotest Pharmaceuticals Corporation
Study Director: Kenneth C. Anderson, MD Dana-Farber Cancer Institute

Responsible Party: Biotest Pharmaceuticals Corporation Identifier: NCT01001442     History of Changes
Other Study ID Numbers: 975
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: August 2016

Keywords provided by Biotest Pharmaceuticals Corporation:
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases