Relapsed and/or Refractory Multiple Myeloma
Conditions
Interventions
investigational material(s)
Generic name etc : Ixazomib, Lenalidomide, Dexamethasone
INN of investigational material : Ixazomib, Lenalidomide, Dexamethasone
Therapeutic category code : 429 Other antit
Sponsors
Takeda Pharmaceutical Company Limited
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.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
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 patients 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression-Free Survival (PFS) Time Frame: Up to 36 Months as a maximum PFS was defined as the period from the start ofIRd therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase >= 0.5 g/dl or urine M-component increase >= 200 mg/24-hour/ difference between involved and uninvolved free light chain (FLC) levels increase >10 mg/dl or bone marrow plasma cell >= 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy PFS Rate at 12 Months and 24 Months after the Start of Treatment Time Frame: 12 months and 24 months PFS was defined as the period from the start of IRd therapy in standard medical care to the time of confirmed PD or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by IMWG Criteria. efficacy Overall Survival (OS) Timeframe; Up to 36 months as a maximum OS is defined as the period from the start of IRd therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. efficacy Percentage of Participants who Achieve or Maintain Any Best Response Time Frame: Up to 36 months as a maximum Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. Per IMWG criteria, PR: >=50% reduction of serum M protein+reduction in 24-hour urinary M protein by >=90%/ to =50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ >=50% reduction in bone marrow plasma cells, if >=30% at baseline/ >=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ >=90% reduction in serum M-protein+urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum+urine +disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. efficacy Time to Next Treatment (TTNT) Timeframe; Up to 36 months as a maximum TTNT will be measured as the period from the start of IRd therapy in standard medical care to the start of next treatment or time when death is confirmed (regardless of the cause of death), whichever is earlier. efficacy Duration of Therapy (DOT) Timeframe; Up to 36 months as a maximum DOT is defined as the treatment duration of IRd therapy. efficacy Percentage of Participants who Continu | — |
Countries
Japan
Outcome results
None listed