A Phase II Study to Assess the Safety and Efficacy of DBd Combination Therapy (DOXIL/CAELYX) [Doxorubicin HCL Liposome Injection], VELCADE [Bortezomib] and Dexamethasone) for Previously Untreated Multiple Myeloma Patients
This was a single-arm, open-label, Phase II multi-centre study in Canada only. A total of 50
newly diagnosed multiple myeloma patients who were eligible for stem cell transplant were
targeted for recruitment to this study. Combination doxorubicin HCL liposome injection,
bortezomib and dexamethasone induction therapy was given for 4 cycles in preparation for
stem cell collection and transplant. As remission status after induction and prior to the
first or second auto-transplant has been shown to be the major determinant of both event
free and overall survival in multiple myeloma patients, the goal has been to improve
response rates through the use of various combinational approaches. As such, the objective
of the present study was to test the hypothesis that treatment with this regimen could
result in a higher complete + near complete response rate (CR + nCR) prior to stem cell
transplant, than obtained with current regimens, and then to confirm the response rate
post-transplant. Safety was evaluated using adverse event reportings, clinical laboratory
tests and tests for cardiac function (multiple-gated acquisition scan/echocardiogram and
electrocardiogram). Four 21-day cycles of combination induction therapy consisting of 1.3
mg/m2 bortezomib (given i.v. Days 1, 4, 8, 11) + 30 mg/m2 Doxil/Caelyx (given i.v. Day 4) +
40 mg Dex (given po Days 1-4, 8-11, 15-18 Cycle 1 only; Days 1-4 Cycles 2-4).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint was complete response (CR) and near complete response rate (nCR) post induction therapy (i.e. 4 cycles of therapy). Each cycle consisted of 21 days.
Janssen-Ortho Inc. Clinical Trial
Study Director
Janssen-Ortho Inc., Canada
United States: Institutional Review Board
CR010927
NCT00561743
November 2005
May 2007
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