A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone

Takeda

Status: Completed

Conditions: Relapsed and/or Refractory Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Ixazomib; Drug: Dexamethasone

Study type: Observational

Funder types: Industry

Identifiers

NCT03433001

C16042

JapicCTI-183860 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.

Full description

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM) under the conditions of standard medical care. This study is a non-interventional (observational), domestic, multicenter, prospective study in patients with RRMM. This study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in Japanese patients with RRMM as standard medical care. In addition, an exploratory study of biomarkers will be conducted in this study.

The study will enroll approximately 300 patients. All participants will receive Ixazomib + Lenalidomide + Dexamethasone (IRd) therapy as standard medical care.

This multi-center trial will be conducted in Japan. The overall time of observational period in this study will be 36 months. For each participant, the observation period will be from the start of IRd therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier.

Enrollment: 295 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 participants 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

Trial design

295 participants in 1 patient group

Ixazomib + Lenalidomide + Dexamethasone

Description:

Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.

Treatment:

Drug: Dexamethasone

Drug: Ixazomib

Drug: Lenalidomide