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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031216

Enrollment

300

Registered

2018-02-09

Start date

2018-04-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed and/or Refractory Multiple Myeloma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women aged 20 years or older at the time of enrollment 2. Patients with RRMM 3. Patients who are scheduled to start IRd therapy 4. Patients who can provide written informed consent of their own free will before the start of study treatment 5. Patients 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

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakeda Study Registration Call Center Takeda Study Registration Call Center

Takeda Pharmaceutical Company Limited Medical Research, Global Medical Affairs-Japan,

Japan.Oncology.IIR.Office@takeda.com03-3278-2111

Outcome results