A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
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|ClinicalTrials.gov Identifier: NCT03433001|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment|
|Relapsed and/or Refractory Multiple Myeloma||Drug: Ixazomib Drug: Lenalidomide Drug: Dexamethasone|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone|
|Actual Study Start Date :||April 2, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Ixazomib + Lenalidomide + Dexamethasone
Participants will take ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone will not be defined by the protocol but according to the package insert of each drug.
- Progression-Free Survival (PFS) [ Time Frame: Up to 36 Months as a maximum ]PFS is defined as is defined as the period from the start of IRd therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever is earlier. PFS will be 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 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.
- PFS Rate at 12 Months and 24 Months after the Start of Treatment [ Time Frame: 12 months and 24 months ]PFS is defined as is 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 is earlier. PFS will be assessed by IMWG Criteria.
- Overall Survival (OS) [ Time Frame: 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.
- 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 <200 mg/24-hour or ≥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.
- Time to Next Treatment (TTNT) [ Time Frame: 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.
- Duration of Therapy (DOT) [ Time Frame: Up to 36 months as a maximum ]DOT is defined as the treatment duration of IRd therapy.
- Percentage of Participants who Continue to Receive Treatment at 12 Months and 24 Months after Start of Treatment [ Time Frame: 12 months and 24 months ]
- Overall Response Rate (ORR) [ Time Frame: Up to 36 months as a maximum ]ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.
- Percentage of Participants who Achieve VGPR or Better (CR+VGPR) [ Time Frame: Up to 36 months as a maximum ]The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy.
- 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) [ Time Frame: Up to 36 months as a maximum ]EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
- Patient-Reported Outcome HRQoL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score [ Time Frame: Up to 36 months as a maximum ]EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.
- Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants who Achieved CR [ Time Frame: Up to 36 months as a maximum ]Rate of MRD will be calculated by the percentage of participants who are MRD-negative.
- Relative Dose Intensity (RDI) [ Time Frame: Up to 36 months as a maximum ]RDI is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals [dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles].
- Percentage of Participants with Bone Lesions (Bone Evaluation) [ Time Frame: Up to 36 months as a maximum ]
- Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs) [ Time Frame: Up to 36 months as a maximum ]An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433001
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Takeda Selected Site||Recruiting|
|Study Director:||Study Director||Takeda|