Multiple Myeloma Clinical Trial
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
Major Inclusion Criteria:
Signed written informed consent must be obtained and documented according to the International Conference on Harmonisation (ICH) and be in accordance with local regulatory requirements
A histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options
≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase
Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after their last dose
Females of childbearing potential must have a negative serum pregnancy test
Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN). Patients whose disease involves the liver and who have laboratory values of AST ≤ 3.5 ULN, AST ≤ 3.5 ULN, and albumin ≥ 35g/L may be enrolled if agreed upon by the Principal Investigator and Medical Monitor for the Sponsor
Total bilirubin < 1.5 x ULN, except for cases in which elevation of total bilirubin is due to elevated levels of unconjugated bilirubin consistent with a diagnosis of Gilbert's Syndrome
Life expectancy ≥ 3 months
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There are 8 Locations for this study
Denver Colorado, 80218, United States
Indianapolis Indiana, 46202, United States
Germantown Tennessee, 38138, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Vancouver Washington, 98684, United States
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