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

Phase 4

• Conditions: Relapsed and/or Refractory Multiple Myeloma

• Registration Number: JPRN-UMIN000031216
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-09
• Study Completion: 2021-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1. Female patients who are nursing or pregnant 2. Patients who have been treated with ixazomib 3. Patients with hypersensitivity to any of the components of IRd therapy, their analogs or excipients 4. Patients 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. Patients who are not registered with, or comply with, the guidelines of the lenalidomide management program 6. Patients 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
Progression-free survival (PFS)

Secondary Outcome Measures

Name	Time	Method
PFS rate at 12 months and 24 months Overall survival (OS) Best response Time to next treatment (TTNT) Duration of therapy (DOT) Proportion of patients who continue to receive treatment at 12 months and 24 months after start of treatment Overall response rate (ORR) Complete response (CR) plus very good partial response (VGPR) rate (CR+VGPR rate) Patient-reported outcomes: health-related quality of life (HRQoL), as evaluated by the EORTC QLQ-C30 and MY-20 instruments Rate of minimal residual disease (MRD) negativity in the bone marrow of patients who achieve CR Relative dose intensity (RDI) for ixazomib, lenalidomide and dexamethasone Bone evaluation AEs