Multiple myeloma
Conditions
Brief summary
Part 1: 1. The number of patients who achieve MRD negativity measured by Euroflow at 30-45 days after the 4th cycle of consolidation therapy has started., Part 2: 1. PFS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to disease progression or death due to any cause following 2.L treatment. 2. OS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to death of any cause following 2.L treatment.
Detailed description
Part 1: 1. The PFS rate of patients receiving 4 cycles of VRd as consolidation 2. The OS rate of patients receiving 4 cycles of VRd as consolidation 3. The number of AEs and relevant laboratory parameters monitored at every visit from entry into part 1 of the study until end of part 1 4. The proportion of patients who achieve PR or better following 4 cycles of VRd consolidation treatment, Part 2: 1.Time from randomization to start of 3.L therapy (TTNT) 2.The proportion of patients who achieve MRD negativity during 2.L treatment, monitored by MRD Euroflow at 6 and 18 months in arm A, and after achieving CR in arm B (first MRD testing after 6 months). 3.Patient reported outcome HRQOL forms will be filled out by patients at defined time points during the study and finally at relapse after 2.L therapy. 4.The number of AEs
Interventions
DRUGDexametason Abcur 1 mg tabletter
DRUGCARFILZOMIB
DRUGDARATUMUMAB
Sponsors
Oslo University Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: 1. The number of patients who achieve MRD negativity measured by Euroflow at 30-45 days after the 4th cycle of consolidation therapy has started., Part 2: 1. PFS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to disease progression or death due to any cause following 2.L treatment. 2. OS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to death of any cause following 2.L treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: 1. The PFS rate of patients receiving 4 cycles of VRd as consolidation 2. The OS rate of patients receiving 4 cycles of VRd as consolidation 3. The number of AEs and relevant laboratory parameters monitored at every visit from entry into part 1 of the study until end of part 1 4. The proportion of patients who achieve PR or better following 4 cycles of VRd consolidation treatment, Part 2: 1.Time from randomization to start of 3.L therapy (TTNT) 2.The proportion of patients who achieve MRD negativity during 2.L treatment, monitored by MRD Euroflow at 6 and 18 months in arm A, and after achieving CR in arm B (first MRD testing after 6 months). 3.Patient reported outcome HRQOL forms will be filled out by patients at defined time points during the study and finally at relapse after 2.L therapy. 4.The number of AEs | — |
Countries
Lithuania, Norway
Outcome results
None listed