Newly Diagnosed Multiple Myeloma
Conditions
Brief summary
For the induction phase: Rate of patients who have VGPR or better response according to IMWG criteria and are MRD-negative as assessed by flow cytometry following six cycles of induction treatment, For the maintenance phase: 3-year PFS rate calculated from randomization
Detailed description
1. Objective response rate (ORR) following induction and consolidation treatment with EKRd versus KRd (response evaluation according to IMWG criteria, refer to Appendix A), 2. ORR at the end of study treatment programme following induction, ASCT, consolidation, and maintenance treatment (response evaluation according to IMWG criteria, refer to Appendix A; target population: Intent - to - Treat), 3. PFS, defined as the time from randomization to the date of disease progression after firstline therapy (study treatment) or death from any cause, 4. PFS 2, defined as the time from randomization to the date of disease progression or death from any cause during/after second-line therapy in the Intent-to-Treat Population, 5. PFS and OS in correlation with cytogenetic abnormalities, 6. Improvement of MRD negativity rate as assessed by flow-cytometry following consolidation treatment, 7. Improvement of MRD negativity rate as assessed by flow-cytometry during maintenance treatment, 8. Disease-free survival (DFS) for patients who obtain MRD negativity as assessed by flowcytometry (at any time point), 9. OS, 10. OS for patients who obtain MRD negativity as assessed by flow-cytometry (at any time point), 11. QoL evaluated with EORTC-QLQ C30 and EORTC multiple myeloma module QLQ-MY20, 12. Type, incidence, relatedness, and severity of adverse events according to NCI CTCAE version 4.03, 13. Occurrence of laboratory abnormalities
Interventions
DRUGElotuzumab
DRUGLENALIDOMIDE
DRUGDEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EUR.
DRUGLenalidomide
DRUGKyprolis 60 mg powder for solution for infusion
DRUGDEXAMETHASONE
Sponsors
Universitaetsklinikum Wuerzburg AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the induction phase: Rate of patients who have VGPR or better response according to IMWG criteria and are MRD-negative as assessed by flow cytometry following six cycles of induction treatment, For the maintenance phase: 3-year PFS rate calculated from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR) following induction and consolidation treatment with EKRd versus KRd (response evaluation according to IMWG criteria, refer to Appendix A), 2. ORR at the end of study treatment programme following induction, ASCT, consolidation, and maintenance treatment (response evaluation according to IMWG criteria, refer to Appendix A; target population: Intent - to - Treat), 3. PFS, defined as the time from randomization to the date of disease progression after firstline therapy (study treatment) or death from any cause, 4. PFS 2, defined as the time from randomization to the date of disease progression or death from any cause during/after second-line therapy in the Intent-to-Treat Population, 5. PFS and OS in correlation with cytogenetic abnormalities, 6. Improvement of MRD negativity rate as assessed by flow-cytometry following consolidation treatment, 7. Improvement of MRD negativity rate as assessed by flow-cytometry during maintenance treatment, 8. | — |
Countries
Austria, Germany
Outcome results
None listed