Waldenström’s Macroglobulinemia
Conditions
Brief summary
Complete Remission (CR) or Very Good Partial Remission (VGPR) 12 months from randomization using the modified response criteria updated at the Sixth IWWM[1] (CR/VGPR).
Detailed description
Response rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 12 months, Response rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 24 monthsResponse rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 24 months, Best response, Time to best response, Time to first response, Time to treatment failure, Remission Duration, Progression free survival, Cause specific survival, Overall survival, Safety, Quality of life
Interventions
DRUGKyprolis 60 mg powder for solution for infusion
Sponsors
Universitaetsklinikum Ulm AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission (CR) or Very Good Partial Remission (VGPR) 12 months from randomization using the modified response criteria updated at the Sixth IWWM[1] (CR/VGPR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 12 months, Response rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 24 monthsResponse rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 24 months, Best response, Time to best response, Time to first response, Time to treatment failure, Remission Duration, Progression free survival, Cause specific survival, Overall survival, Safety, Quality of life | — |
Countries
Austria, Germany, Greece
Outcome results
None listed