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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: BT062


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT062<br>BT062 single agent dose escalation | Drug: BT062<br>* biologic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Refractory, Relapsed