Multiple myeloma
Conditions
Brief summary
PFS, defined as the time from the date of randomization to the date of first documented disease progression per IMWG criteria by IRC or death from any cause in the absence of progression, whichever occurs first, MRD negative status, defined as achieving MRD negativity at 10-5 sensitivity threshold assessed by NGS at least once during the time of confirmed CR or better response per IMWG criteria by IRC
Detailed description
PFS2, defined as the time from the date of randomization to the date of documented disease progression following the first subsequent antimyeloma therapy or death from any cause, whichever is earlier, OS, defined as the time from the date of randomization until the date of death due to any cause, CR+, defined as confirmed CR or sCR per IMWG criteria by IRC, VGPR+, defined as confirmed VGPR, CR, sCR per IMWG criteria by IRC, sMRD, defined as achieving MRD negative status at 10-5 sensitivity threshold assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR or better response per IMWG criteria by IRC, DoR, defined as the time from first documented evidence of PR or better until PD or death due to PD (among participants who achieve confirmed PR+ by IRC), TTST, defined as time from randomization until the date of start of second subsequent line of antimyeloma therapy (irrespective of PD) or death due to any cause, whichever is earlier, Incidence and severity of AEs and SAEs, Incidence of AEs leading to dose modifications or study intervention discontinuation, Incidence and severity of ocular findings on ophthalmic exam (changes in VA and corneal findings), Maximum post-baseline PRO-CTCAE score for each item attribute, Change from baseline in HRQoL as measured by EORTC QLQ-C30., Change from baseline in HRQoL as measured by EORTC QLQ-MY20 (Disease Symptoms domain), Plasma concentrations of belantamab mafodotin
Interventions
DRUGRevlimid 25 mg hard capsules
DRUGRevlimid 5 mg hard capsules
DRUGRevlimid 10 mg hard capsules
DRUGDARZALEX 1800 mg solution for injection
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from the date of randomization to the date of first documented disease progression per IMWG criteria by IRC or death from any cause in the absence of progression, whichever occurs first, MRD negative status, defined as achieving MRD negativity at 10-5 sensitivity threshold assessed by NGS at least once during the time of confirmed CR or better response per IMWG criteria by IRC | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS2, defined as the time from the date of randomization to the date of documented disease progression following the first subsequent antimyeloma therapy or death from any cause, whichever is earlier, OS, defined as the time from the date of randomization until the date of death due to any cause, CR+, defined as confirmed CR or sCR per IMWG criteria by IRC, VGPR+, defined as confirmed VGPR, CR, sCR per IMWG criteria by IRC, sMRD, defined as achieving MRD negative status at 10-5 sensitivity threshold assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR or better response per IMWG criteria by IRC, DoR, defined as the time from first documented evidence of PR or better until PD or death due to PD (among participants who achieve confirmed PR+ by IRC), TTST, defined as time from randomization until the date of start of second subsequent line of antimyeloma therapy (irrespective of PD) or death due to any cause, | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Norway, Poland, Spain
Outcome results
None listed