Phase 1b study evaluating OPomD in relapsed or refractory multiple myelomaINTREPID-1
Study Details
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.
Protocol Summary
Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone
Timeframe: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment
Timeframe: Data collected up to 2 months from the date of last subject enrollment.
Incidence of treatment-emergent adverse events
Timeframe: Data collected up to 2 months from the date of last subject enrollment.
Number of patients with changes in laboratory test results
Timeframe: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
Maximum observed concentration (Cmax)
Timeframe: At the highest concentration of drug in the blood.
Time to Cmax (tmax)
Timeframe: time to achieve Cmax.
Area under the concentration-time curve
Timeframe: time 0 to the time of last quantifiable concentration (AUClast)
Overall response
Timeframe: All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
Best overall response
Timeframe: All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
Progression free survival
Timeframe: 4 months
Duration of response
Timeframe: 4 months