relapsed / refractory multiple myeloma
Conditions
Brief summary
Progression free survival (PFS; i.e. time from the first dose of iberdomide-cyclophosphamide-dexamethasone to progression or death from any cause, whichever comes first)
Detailed description
Overall response rate. In this analysis we will consider the best response obtained during treatment according to the international myeloma working group (IMWG) criteria, Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, Overall survival measured from first dose of iberdomide-cyclophosphamide-dexamethasone, to time of death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive., Time to response defined as time from first dose of iberdomide-cyclophosphamidedexamethasone to the first objective documentation of PR or better., Duration of response defined as time from documentation of tumor response to disease progression., Time to second objective disease progression (PFS2) defined as time from first dose of iberdomide-cyclophosphamide-dexamethasone to 2nd disease progression or death from any cause., Time to next treatment (TTNT) defined as the date from first dose of iberdomide- cyclophosphamide-dexamethasone to first day when subject receives another myeloma treatment. Subjects who do not start new myeloma therapy are censored at the last known alive date or first dose date, whichever is later.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS; i.e. time from the first dose of iberdomide-cyclophosphamide-dexamethasone to progression or death from any cause, whichever comes first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate. In this analysis we will consider the best response obtained during treatment according to the international myeloma working group (IMWG) criteria, Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, Overall survival measured from first dose of iberdomide-cyclophosphamide-dexamethasone, to time of death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive., Time to response defined as time from first dose of iberdomide-cyclophosphamidedexamethasone to the first objective documentation of PR or better., Duration of response defined as time from documentation of tumor response to disease progression., Time to second objective disease progression (PFS2) defined as time from first dose of iberdomide-cyclophosphamide-dexamethasone to 2nd disease progression or | — |
Countries
Netherlands