Clinical trial NCT03433001: A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
Official title: A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed and/or Refractory Multiple Myeloma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 295
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult men and women who have a confirmed diagnosis of multiple myeloma, who is scheduled to begin treatment with IRd due to relapsed and/or refractory disease, and who meet other eligibility criteria.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 36 Months as a maximum
Secondary outcomes:
measure: PFS Rate at 12 Months and 24 Months After the Start of Treatment
timeFrame: 12 months and 24 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months as a maximum
measure: Percentage of Participants Who Achieve or Maintain Any Best Response
timeFrame: Up to 36 months as a maximum
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 36 months as a maximum
measure: Duration of Therapy (DOT)
timeFrame: Up to 36 months as a maximum
measure: Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment
timeFrame: 12 months and 24 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 36 months as a maximum
measure: Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)
timeFrame: Up to 36 months as a maximum
measure: Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score
timeFrame: Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
measure: Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
timeFrame: Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
measure: Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
timeFrame: Up to 36 months as a maximum
measure: Relative Dose Intensity (RDI)
timeFrame: Up to 36 months as a maximum
measure: Percentage of Participants With Bone Lesions (Bone Evaluation)
timeFrame: Up to 36 months as a maximum
measure: Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)
timeFrame: Up to 36 months as a maximum
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: