Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)
Conditions
Brief summary
To evaluate the proportion of patients with MRD negativity (defined by NGF (next generation flow) at 10^-5) after end of induction treatment in the two arms.
Detailed description
To evaluate the Overall Response Rate (ORR), Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm., To compare the Progression-free (PFS) and Overall Survival (OS) between the two arms., To evaluate the proportion of patients with MRD negativity (defined by NGF at 10^-5) after 12 months (13 cycles) of maintenance treatment., To evaluate the Time to Progression (TTP) in each arm., To evaluate the PFS in high risk cytogenetic population defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21., To evaluate the Duration of Response in each arm., To evaluate safety in both treatment arms., To assess disease-specific and a generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility and health status., To evaluate PFS of potential second line therapy.
Interventions
Sponsors
Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the proportion of patients with MRD negativity (defined by NGF (next generation flow) at 10^-5) after end of induction treatment in the two arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the Overall Response Rate (ORR), Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm., To compare the Progression-free (PFS) and Overall Survival (OS) between the two arms., To evaluate the proportion of patients with MRD negativity (defined by NGF at 10^-5) after 12 months (13 cycles) of maintenance treatment., To evaluate the Time to Progression (TTP) in each arm., To evaluate the PFS in high risk cytogenetic population defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21., To evaluate the Duration of Response in each arm., To evaluate safety in both treatment arms., To assess disease-specific and a generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility and health status., To evaluate PFS of potential second line therapy. | — |
Countries
Austria, Greece
Outcome results
None listed