Title A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects with Relapsed or Relapsed/Refractory Multiple Myeloma
Principal Investigator Kelvin Lee, MD
Study Number 173310
Summary This is a Phase I/IIa study that will evaluate the dose limiting toxicities (side effects that are severe enough that you cannot take any more drug at the dose) and the maximum tolerated dose (the highest dose that a human can take on an ongoing basis with minimal or mild side effects) of the compound BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.
- Subjects, age greater than or equal to 18 years
- Diagnosis of relapsed or relapsed/refractory multiple myeloma
- Previous treatment with both an immunomodulator and a proteosome inhibitor therapy
- Ability to understand and willingness to sign a written informed consent document
- Ability to adhere with the study visit schedule and other protocol procedures
- Normal organ and marrow function.