Subcutaneous (SC) Bortezomib-Regimens for Patients With RR MM Failing Prior IV Bortezomib-Containing Regimens
Status:
Terminated
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who will
receive treatment with a SC bortezomib-containing combination regimen that does not contain
thalidomide or vincristine. The patients will be required to have received a prior IV
bortezomib containing combination regimen that did not contain thalidomide or vincristine and
that differs from the SC bortezomib-containing one. In between the time that the patient
received the IV bortezomib-based combination regimen and enrollment onto this study, patients
may have received other non-bortezomib-based regimens as long as these treatments did not
contain thalidomide or vincristine. This study will enroll patients who have relapsed or have
become refractory to their prior IV-administered bortezomib-containing combination regimen as
demonstrated by progressive disease while on or following that regimen. Patients must have
received 4 doses of a minimum of 1.0 mg/m2 of bortezomib administered IV in no more than 4
weeks per cycle. Patients must have received at least one cycle meeting this definition and
have shown progressive disease to be considered eligible. Patients who have relapsed or have
become refractory to their most recent IV bortezomib-containing combination regimen are
eligible regardless of when they received that regimen, as long as they meet the above
criteria.
The study will consist of a screening period, followed by up to eight open label treatment
cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a
follow-up period.