A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone

Phase 4

Completed

• Conditions: Relapsed and/or Refractory Multiple Myeloma

• Registration Number: JPRN-jRCT1080223804
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

The results of this study have shown that IRd therapy is an effective and well-tolerated treatment option as well under conditions outside of clinical trials.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-09
• Study Completion: 2021-06-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

1.Men and women aged 20 years or older at the time of enrollment
2.Patients with RRMM
3.Participants who are scheduled to start IRd therapy
4.Participants who can provide written informed consent of their own free will before the start of study treatment
5.Participants who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study

Exclusion Criteria

1.Female participants who are nursing or pregnant
2.Participants who have been treated with ixazomib
3.Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
4.Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for patients with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment
5.Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program
6.Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Progression-Free Survival (PFS)<br>Time Frame: Up to 36 Months as a maximum<br>PFS was defined as the period from the start ofIRd therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase >= 0.5 g/dl or urine M-component increase >= 200 mg/24-hour/ difference between involved and uninvolved free light chain (FLC) levels increase >10 mg/dl or bone marrow plasma cell >= 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.