NCT00932698

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma

An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.

Detailed description

The drug being tested in this study is ixazomib. Ixazomib is being tested to treat people who have multiple myeloma. This study will look at the safety and efficacy of ixazomib and will enroll approximately 60 participants. Participants will receive ixazomib by oral capsule twice weekly on Days 1, 4, 8, and 11 of a 21-day cycle. The study will consist of a dose escalation phase to determine the MTD, followed by an expansion phase in which participants will be treated at the MTD. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 8 years.

Conditions

• Relapsed and Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	Ixazomib capsules

Timeline

• Start date: 2009-10-12
• Primary completion: 2013-06-20
• Completion: 2017-05-23
• First posted: 2009-07-03
• Last updated: 2019-08-07
• Results posted: 2019-08-07

Locations

5 sites across 1 country: United States