Multiple Myeloma Clinical Trial
Official title:
An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment
The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.
The drug being tested in this study is called ixazomib. Ixazomib was being tested to treat
people who had newly diagnosed multiple myeloma who had not previously received systemic
treatment. This study was conducted in two Phases. Phase 1 looked at side effects and lab
results in people who took ixazomib to determine the MTD and RP2D. Phase 2 looked at overall
response rates and side effects in people who took ixazomib.
The study enrolled 15 patients in Phase 1 and 50 patients in Phase 2. Participants in Phase 1
were assigned to cohorts and received ixazomib 1.68, 2.23, 2.97, or 3.95 mg/m^2 in addition
to dexamethasone 40 mg and lenalidomide 25 mg. Participants in Phase 2 received ixazomib 4.0
mg fixed dose in addition to dexamethasone 40 mg and lenalidomide 25 mg. In both Phases study
treatment was administered in 28-day Cycles as follows: ixazomib Days 1, 8 and 15,
dexamethasone Days 1, 8, 15 and 22, and lenalidomide 25 mg Days 1 through 21.
This multi-center trial was conducted in the United States. The overall time to participate
in this study was 12, 28-day cycles with the option to continue into a maintenance portion in
the absence of disease progression or unacceptable toxicity. Participants made multiple
visits to the clinic and a final visit 30 days after last dose of study drug for a follow-up
assessment.
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