N/A
N=295
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
Relapsed and/or Refractory Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT03433001 ↗Enrolled (actual)
295
Serious AEs
32.5%
Results posted
Dec 2023
Primary outcome: Primary: Progression-Free Survival (PFS) — 4.79 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ixazomib (Drug); Lenalidomide (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
4.79 | — |
| SECONDARY PFS Rate at 12 Months and 24 Months After the Start of Treatment |
57; 41 | — |
| SECONDARY Overall Survival (OS) |
20.23 | — |
| SECONDARY Percentage of Participants Who Achieve or Maintain Any Best Response |
20.0; 8.5; 22.0 | — |
| SECONDARY Time to Next Treatment (TTNT) |
5.02 | — |
| SECONDARY Duration of Therapy (DOT) |
353.3 | — |
| SECONDARY Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment |
40.0; 21.7 | — |
| SECONDARY Overall Response Rate (ORR) |
53.9 | — |
| SECONDARY Percentage of Participants Who Achieve VGPR or Better (CR+VGPR) |
31.5 | — |
| SECONDARY 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 |
59.95; 75.00 | — |
| SECONDARY Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score |
19.33; 11.11; 17.80; 16.67; 28.18; 16.67 | — |
| SECONDARY Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR |
26.7; 16.7; 6.7; 50.0 | — |
| SECONDARY Relative Dose Intensity (RDI) |
66.49; 44.72; 41.07 | — |
| SECONDARY Percentage of Participants With Bone Lesions (Bone Evaluation) |
21.5 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs) |
249 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 20 years or older at the time of enrollment
- Patients with RRMM
- Participants who are scheduled to start IRd therapy
- Participants who can provide written informed consent of their own free will before the start of study treatment
- 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
- Female Participants who are nursing or pregnant
- Participants who have been treated with ixazomib
- Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
- 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
- Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program
- Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
Data sourced from ClinicalTrials.gov (NCT03433001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.