Relapsed/refractory multiple myeloma in patients who have received 1 to 3 prior lines of therapy and have been exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody
Conditions
Brief summary
PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first, Minimal residual disease (MRD)-negative complete response (CR) rate at 9 months, defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 105 nucleated cells per IMWG criteria using NGS) {Kumar 2016}. CR/sCR per IMWG criteria is determined by IRC
Detailed description
Complete response (CR) rate (CR/stringent CR [sCR]) per IMWG criteria by IRC, Overall minimal residual disease (MRD) negativity (minimum 10^−5), Overall survival (OS), Overall response rate, MRD-negative CR/sCR and MRD-negative very good partial response (VGPR)+, Sustained MRD negativity, Duration of response, Time to progression, Time to next treatment, Incidence, seriousness, and severity of all adverse events (AEs), Levels of anti-anitocabtagene autoleucel chimeric antigen receptor (CAR) antibodies (anitocabtagene autoleucel arm), Presence of replication-competent lentivirus (RCL) (anitocabtagene autoleucel arm), Change from baseline quality of life scores across postbaseline assessment visits as measured by: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Multiple Myeloma Module (EORTC QLQ-MY20). European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L), Frequency of hospitalizations, inpatient days, intensive care unit days, and reasons for hospitalization
Interventions
DRUGImnovid 2 mg hard capsules
DRUGImnovid 1 mg hard capsules
DRUGImnovid 3 mg hard capsules
DRUGBortezomib Fresenius Kabi 2.5 mg powder for solution for injection
DRUGImnovid 4 mg hard capsules
DRUGBortezomib Fresenius Kabi 3.5 mg powder for solution for injection
DRUGBortezomib Fresenius Kabi 1 mg powder for solution for injection
DRUGKyprolis 60 mg powder for solution for infusion
Sponsors
Kite Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first, Minimal residual disease (MRD)-negative complete response (CR) rate at 9 months, defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 105 nucleated cells per IMWG criteria using NGS) {Kumar 2016}. CR/sCR per IMWG criteria is determined by IRC | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate (CR/stringent CR [sCR]) per IMWG criteria by IRC, Overall minimal residual disease (MRD) negativity (minimum 10^−5), Overall survival (OS), Overall response rate, MRD-negative CR/sCR and MRD-negative very good partial response (VGPR)+, Sustained MRD negativity, Duration of response, Time to progression, Time to next treatment, Incidence, seriousness, and severity of all adverse events (AEs), Levels of anti-anitocabtagene autoleucel chimeric antigen receptor (CAR) antibodies (anitocabtagene autoleucel arm), Presence of replication-competent lentivirus (RCL) (anitocabtagene autoleucel arm), Change from baseline quality of life scores across postbaseline assessment visits as measured by: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Multiple Myeloma Module (EORTC QLQ-MY20). European Quality of Life 5-Dimension 5- | — |
Countries
Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed