Elucidation of efficacy, safety, mutations, and immunologic factors in ixazomib maintenance therapy for transplant-ineligible patients with multiple myeloma intolerant to lenalidomide therapy due to frailty or adverse events
Not Applicable
Recruiting
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000048285
- Lead Sponsor
- Dokkyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Primary entry 1)Those have a past history of allergy to ixazomib 2)Pregnant woman or possible pregnant woman Secondary entry 1)Those were treated by 25mg dose of lenalidomide as an induction therapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method (1)Identification of driver mutations using whole-genome sequencing (WGS) and quantification of the size of clones with driver mutations in BM using digital droplet polymerase chain reaction (PCR). (2)Examination of the dynamics of IgG, IgA, IgM as well as flow cytometric analysis of immune related genes in myeloma and effector cells. (3)Time to Next Treatment (TTNT).