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

This study has been completed.
Sponsor:
Collaborator:
Biotest
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00723359
First received: July 24, 2008
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: BT062
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biotest Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: On a weekly basis for the duration of the study ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Time Frame: About every 2 months for the duration of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Qualitative and quantitative toxicities [ Time Frame: On a weekly basis for the duration of the study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: On a weekly basis for the duration of the study ] [ Designated as safety issue: No ]
  • Anti-tumor activity [ Time Frame: At the beginning of each treatment cycle ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BT062
BT062 single agent dose escalation
Drug: BT062
biologic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723359

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
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
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Biotest Pharmaceuticals Corporation
Biotest
Investigators
Study Director: Kenneth C. Anderson, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00723359     History of Changes
Other Study ID Numbers: 969
Study First Received: July 24, 2008
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biotest Pharmaceuticals Corporation:
Multiple Myeloma
Refractory
Relapsed

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

ClinicalTrials.gov processed this record on April 17, 2014