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

Biotest

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: BT062

Study type

Interventional

Funder types

Industry

Identifiers

NCT00723359

969

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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