Multiple Myeloma Clinical Trial
Official title:
An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment
The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both phases of the study included participants who had newly diagnosed multiple myeloma and were ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or coexisting conditions and for whom standard MP treatment was indicated.
The drug tested in this study was called ixazomib (MLN9708). Ixazomib was tested to treat the
people with newly diagnosed multiple myeloma requiring systemic treatment who were not
eligible for stem cell transplantation. This study determined the safety, tolerability,
efficacy, quality of life (QOL), and pharmacokinetics (PK)/pharmacodynamics (PD) of ixazomib.
The study enrolled 61 patients. The study was conducted in 2 parts: 1) phase 1 dose
escalation and 2) phase 2 expansion at maximum tolerated dose. Participants were enrolled to
receive:
- Ixazomib 3.0 mg, 3.7 mg, 4.0 mg, or 5.5. mg depending on the treatment assignment
This multicenter trial was conducted in the Unites states, Canada, United Kingdom, Spain and
Czech Republic. The overall time to participate in this study is 5.5 years. Participants made
multiple visits to the clinic and were followed up every 16 weeks after end of treatment
until disease progression if stopped treatment before disease progression and then every 16
weeks up to start of next therapy or death whichever occurs first.
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