NCT04272775

A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

A Phase 1 Study of MLN9708 in Japanese Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK) of ixazomib alone or in combination with lenalidomide and dexamethasone (Rd), and antitumor activity of ixazomib in participants with RRMM.

Detailed description

The drug being tested in this study is called ixazomib. This study will evaluate the tolerability, safety, and PK of ixazomib administered alone or in combination with lenalidomide and dexamethasone in participants with relapsed and/or refractory multiple myeloma. This study will enroll approximately 24 participants (3 to 6 participants in each dose-escalation cohort). Participants will be assigned to receive treatment in one of the four treatment cohorts: * Cohort 1: Ixazomib 4.0 mg * Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone * Cohort 3: Ixazomib 5.5 mg * Cohort 4: Ixazomib 5.5 mg + Lenalidomide and Dexamethasone This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 7 years. Participants will make a final visit 29 days after receiving their last dose of drug for a follow-up assessment.

Conditions

• Relapsed and/or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	Ixazomib capsules.
DRUG	Lenalidomide	Lenalidomide capsules.
DRUG	Dexamethasone	Dexamethasone tablets.

Timeline

• Start date: 2012-06-05
• Primary completion: 2019-02-15
• Completion: 2019-02-15
• First posted: 2020-02-17
• Last updated: 2020-03-17
• Results posted: 2020-02-28