This phase I trial is evaluating an intravenous drug (BFCR4350A) in patients with multiple myeloma, who have progressed or not responded to prior treatmentAn Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BFCR4350A in Patients With Relapsed or Refractory Multiple Myeloma

Summary

Dose escalation: The study drug will be administered intravenously on a 21-day cycle. Initially, cohorts will consist of 1 participant each. Subsequently will consist of at least 3 participants, unless dose-limiting toxicities (DLTs) are observed in the first 2 prior to enrollment of a third participant. For each cohort, treatment with the first dose will be staggered such that the second participant enrolled in the cohort will receive study drug at least 72 hours after the first participant receives it to allow assessment of any severe and unexpected acute or subacute drug or infusion-related toxicities; dosing in subsequent participants in each cohort will be staggered by at least 24 hours. Expansion: Participants exhibiting acceptable safety and evidence of clinical benefit will be administered study drug every 21 days up to a maximum of 17 cycles until objective disease progression is documented or unacceptable toxicity, whichever occurs first.