Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma
Status:
Completed
Trial end date:
2013-03-28
Target enrollment:
Participant gender:
Summary
The present trial is designed as a phase II study that aims at estimating the efficacy of the
combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple
myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response
or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen
as primary efficacy endpoint.
The estimation of the efficacy rate is to be based on an explorative pilot study, since
immediate embarking on a large-scale comparative efficacy trial would not be acceptable from
the point of view of resources. Moreover, this would induce ethical objections, as it does
not seem to be justifiable to expose a large number of patients to an experimental approach
without sufficient exploratory indications of an improved risk-benefit ratio.