A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma

Relapsed and/or Refractory Multiple Myeloma Clinical Trial

Official title: A Phase 2, Open-Label, Multicenter Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Patients With Relapsed and/or Refractory Multiple Myeloma

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ixazomib plus lenalidomide and dexamethasone in Japanese participants with relapsed and/or refractory multiple myeloma (RRMM).

Clinical Trial Description

This is a phase 2, open label, single arm, multicenter study to evaluate the efficacy and safety of ixazomib plus lenalidomide and dexamethasone in Japanese participants with relapsed and/or refractory multiple myeloma (MM). The participants population will consist of adult men and women who have a confirmed diagnosis of MM, who have received 1 to 3 prior lines of therapy, and who meet other outlined eligibility criteria. Participants will receive study drug (ixazomib 4.mg) on Days 1, 8, and 15 plus lenalidomide (25 mg) on Days 1 through 21 and dexamethasone (40 mg) on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive treatment until progressive disease (PD) or unacceptable toxicity, whichever comes first. Dose modifications may be made based on toxicities. Participant with a low creatinine clearance < 60 mL/min will receive a reduced lenalidomide dose of 10 mg once daily on Days 1 through 21 of a 28-day cycle. The lenalidomide dose may be escalated to 15 mg once daily after 2 cycles if the participant is not responding to treatment and is tolerating the treatment. If renal function normalizes (ie, creatinine clearance >= 60 mL/min) and the participant continues to tolerate this treatment, lenalidomide may then be escalated to 25 mg once daily.

Treatment periods will be defined as 28-day cycles. Participant will be seen at regular treatment cycle intervals while they are participating in the study: four times a treatment cycle for the first 2 cycles, twice a treatment cycle for the 3rd cycle, and then once a treatment cycle for the remainder of their participation in the active treatment and, if applicable, the progression free survival (PFS) and overall survival (OS) follow-up phases of the study.

Response will be assessed by investigator according to the International Myeloma Working Group criteria for all participants every 4 weeks until PD. Central laboratory data will be used for serum M-protein, urine M-protein and serum free light chain. All participants will be followed for survival after progression. Participants will be contacted every 12 weeks until death or termination of the study by the sponsor.

The study will be closed at 24 months from the enrollment of the last participant. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed and/or Refractory Multiple Myeloma

• NCT number: NCT02917941
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2016
• Completion date: August 31, 2019