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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723359
• Other study ID #: 969
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2008
• Last updated: July 16, 2013
• Start date: August 2008
• Est. completion date: April 2012

Study information

• Verified date: July 2013
• Source: Biotest Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• BT062
biologic

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Mount Sinai Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Biotest Pharmaceuticals Corporation	Biotest

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity		On a weekly basis for the duration of the study	Yes
Primary	Maximum tolerated dose		About every 2 months for the duration of the study	Yes
Secondary	Qualitative and quantitative toxicities		On a weekly basis for the duration of the study	Yes
Secondary	Pharmacokinetics		On a weekly basis for the duration of the study	No
Secondary	Anti-tumor activity		At the beginning of each treatment cycle	No