Relapsed or refractory AL amyloidosis
Conditions
Brief summary
The primary end point of the trial is the CR/VGPR/low-dFLC response rate at 6 months/ 4 cycles from start of therapy with blmf, according to consensus response criteria
Detailed description
Evaluation of safety (grade 3 or higher adverse events rates related to blmf therapy, treatment discontinuation rates, any grade hematologic adverse events, any grade non-hematologic adverse events), The limitation in the number of characters in this section does not allow to enter the endpoint. Please refer to the trial protocol, Derived PK parameter values for belantamab mafodotin as data permit
Interventions
None listed
Sponsors
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the trial is the CR/VGPR/low-dFLC response rate at 6 months/ 4 cycles from start of therapy with blmf, according to consensus response criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety (grade 3 or higher adverse events rates related to blmf therapy, treatment discontinuation rates, any grade hematologic adverse events, any grade non-hematologic adverse events), The limitation in the number of characters in this section does not allow to enter the endpoint. Please refer to the trial protocol, Derived PK parameter values for belantamab mafodotin as data permit | — |
Countries
France, Germany, Greece, Italy, Netherlands
Outcome results
None listed