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

A Phase I Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), and Safety of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma

This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating patients with relapsed or refractory multiple myeloma.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: BT062

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• HAHAs, HACAs, or HAMAs in response to previous MAb therapy
• Previous participation in this study
• Malignancy within 3 years before day 1, 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
• 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
• 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 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, or as premedication for administration of certain medications 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
• Pregnant or 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BT062; BT062 single agent dose escalation	Drug: BT062; biologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose limiting toxicity	On a weekly basis for the duration of the study
Maximum tolerated dose	About every 2 months for the duration of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Qualitative and quantitative toxicities	On a weekly basis for the duration of the study
Pharmacokinetics	On a weekly basis for the duration of the study
Anti-tumor activity	At the beginning of each treatment cycle

Collaborators and Investigators

• Sponsor: Biotest Pharmaceuticals Corporation
• Collaborators: Biotest
• Investigators: Study Director: Kenneth C. Anderson, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Estimate): July 18, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Relapsed; Refractory
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 969