Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Refractory, Relapsed
Brief 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.
Interventions
DRUGBT062
biologic
Sponsors
Biotest
Biotest Pharmaceuticals Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed