Multiple Myeloma Clinical Trial
Official title:
An Open-Label, Dose-Escalation, Phase 1 Study Evaluating the Safety and Tolerability of Weekly Dosing of the Oral Form of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and Refractory Multiple Myeloma
The primary objective of this study is to determine the safety profile, tolerability, and maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary objectives include pharmacokinetics and response rates.
The drug being tested in this study is called ixazomib citrate (MLN9708). Ixazomib citrate is
being tested for people who have multiple myeloma who have relapsed after treatment or become
unresponsive to treatment.
This study will determine the maximum tolerated dose (MTD) of ixazomib citrate using a dose
escalation scheme. Once MTD is established, participants will be enrolled at MTD into one of
the 4 expansion cohorts to characterize the safety, tolerability and efficacy of MLN9708.
Blood samples for safety labs, hematology, serum chemistry and pharmacokinetic evaluations
will be obtained at the timepoints specified. Disease response assessment is to be performed
on the first day of every other cycle beginning with Cycle 3.
The study will enroll approximately 60 patients. All participants will receive treatment with
ixazomib citrate. This multi-center trial will be conducted in the United States. The overall
time to participate in this study is up to 60 days, and participants will make 12-16 visits
to the clinic for study procedures.
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