Multiple Myeloma relapsed and/or refractory
Conditions
Brief summary
The primary endpoint of the study is efficacy in terms of: Achievement of molecular minimal residual disease (MRD) 10-5 negativity rate assessed by means of nextgeneration sequencing (ClonoSEQ assay) in patients attaining a complete remission in the first year of treatment.
Detailed description
PFS will be measured from the start of treatment to the date of first observation of disease progression or death to any cause as an event., Overall response rate (ORR)., Progression free survival 2 (PFS2)., Duration of response (DoR)., Overall survival (OS)., Safety., Time to the next anti-myeloma therapy (TNT)., Subgroup analyses: MRD negativity rate and prognostic factors.
Interventions
DRUGImnovid 2 mg hard capsules
DRUGImnovid 3 mg hard capsules
DRUGImnovid 4 mg hard capsules
DRUGSOLDESAM 0
DRUG2% gocce orali
DRUGsoluzione
DRUGDARZALEX 1800 mg solution for injection
DRUGImnovid 1 mg hard capsules
Sponsors
Fondazione European Myeloma Network Italy O.N.L.U.S.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is efficacy in terms of: Achievement of molecular minimal residual disease (MRD) 10-5 negativity rate assessed by means of nextgeneration sequencing (ClonoSEQ assay) in patients attaining a complete remission in the first year of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS will be measured from the start of treatment to the date of first observation of disease progression or death to any cause as an event., Overall response rate (ORR)., Progression free survival 2 (PFS2)., Duration of response (DoR)., Overall survival (OS)., Safety., Time to the next anti-myeloma therapy (TNT)., Subgroup analyses: MRD negativity rate and prognostic factors. | — |
Countries
Italy
Outcome results
None listed