A phase II clinical trial design, including an initial safety run-In period, will be used to assess the rate of VGPR or better for the combination PVD-Dara in the treatment of relapsed or refractory multiple myeloma.~In the run-in period, a maximum of 12 patients will be enrolled onto the trial using the initially proposed regimen and then the trial will be temporarily closed to enrollment, until safety data is reviewed for these patients. Adverse events during the first cycle of treatment of the initially proposed regimen will be closely monitored. If the safety criteria have been met as defined in the protocol, then the trial will reopen to enrollment using the regimen as planned until a total of 72 patients have been enrolled. If safety criteria have not been met as per protocol, then the treatment regimen will be modified for the second cohort of 12 patients after discussion with the study team taking into consideration that if intolerability is due to neutropenia the regimen will be modified by lowering the dose of pomalidomide.~The phase II will begin once the safe doses have been determined in the Run-in period. this Phase II clinical trial was designed to assess whether this 4-agent combination yields a response rate of VGPR or better in more than 65% of patients.~For the regimen found tolerable in the safety period, a two-stage Phase II clinical trial design was chosen to assess whether the VGPR or better response rate is at most 50% against the alternative that the VGPR or better response rate is at least 65%.
This phase II clinical trial design with a safety run-in period will be used to assess the rate of VGPR or better for the combination PVD-Dara in the treatment of RRMM.