Multiple myeloma
Conditions
Brief summary
Dialysis dependent patients: To determine the rate of patients becoming dialysis independent after induction treatment in patients with myeloma induced renal failure requiring dialysis and receiving induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD), Patients not dialysis dependent: To determine the rate of patients achieving improvement of their renal function after induction treatment. Patients receive induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)renal recovery
Detailed description
Progression free survival at 1 year (PFS)in months, defined as the time from day 1 of cycle 1 to the date of first documentation of disease progression based on IMWG criteria or death due to any cause, whichever occurs first., Overall response rate (ORR) being described as complete response, near complete response, very good partial response, partial response, minor response, stable disease, progressive disease. ORR will be assessed according to International Myeloma Working Group (IMWG) criteria, including Minor Response (MR) according to European Society for Blood and Bone Marrow Transplantation (EBMT) criteria, Time to first response defined as days from day 1 of cycle 1 to the first documented response, Time to best response defined (days) from day 1 of cycle 1 to the best documented response, Recording of AE´s, SAE´s, ECOG performance status, assessment of clinical laboratory values., Minimal residual disease will be performed in bone marrow samples (only in patients achieving complete response after cycle 4) according to the Euroflow-protocol (FACS-Analysis) with a sensitivity of 10-5)
Interventions
DRUGKyprolis 60 mg powder for solution for infusion
DRUGFortecortin 4 mg Tabletten
DRUGImnovid 1 mg hard capsules
DRUGImnovid 3 mg hard capsules
DRUGFortecortin 8 mg Tabletten
DRUGImnovid 4 mg hard capsules
DRUGImnovid 2 mg hard capsules
Sponsors
Medizinische Universitaet Innsbruck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dialysis dependent patients: To determine the rate of patients becoming dialysis independent after induction treatment in patients with myeloma induced renal failure requiring dialysis and receiving induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD), Patients not dialysis dependent: To determine the rate of patients achieving improvement of their renal function after induction treatment. Patients receive induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)renal recovery | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival at 1 year (PFS)in months, defined as the time from day 1 of cycle 1 to the date of first documentation of disease progression based on IMWG criteria or death due to any cause, whichever occurs first., Overall response rate (ORR) being described as complete response, near complete response, very good partial response, partial response, minor response, stable disease, progressive disease. ORR will be assessed according to International Myeloma Working Group (IMWG) criteria, including Minor Response (MR) according to European Society for Blood and Bone Marrow Transplantation (EBMT) criteria, Time to first response defined as days from day 1 of cycle 1 to the first documented response, Time to best response defined (days) from day 1 of cycle 1 to the best documented response, Recording of AE´s, SAE´s, ECOG performance status, assessment of clinical laboratory values., Minimal residual disease will be performed in bone marrow samples (only in patients achieving com | — |
Countries
Austria
Outcome results
None listed