A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade
This is an Open-Label (all people know the identity of the intervention), non-randomized,
multicenter (when more than one hospital or medical school team work on a medical research
study), single arm study to evaluate the safety and efficacy of bortezomib in
participants with multiple myeloma (cancer of the types of cells normally found in bone
marrow) who have previously responded to a bortezomib based therapy. Participants will be
non-randomly assigned to single group bortezomib. Participants will be treated with
bortezomib alone or in combination with another drug (dexamethasone). Bortezomib will be
given intravenously (i.v. [into a vein]) twice Weekly, on Days 1, 4, 8 and 11 of each cycle
followed by a 10-day (Days 12 to 21) rest period. The total duration of treatment period
will be 8 cycles, each lasting 3 weeks. The initial bortezomib dose is the last tolerated
dose (1.0 or 1.3 milligram per metersquare [mg/ m^2] on the previous bortezomib-based
treatment. Participants who start the study on a dose of 1.0 mg/m^2 bortezomib and tolerate
the dose well could have their dose escalated to 1.3 mg/m^2. Doses above 1.3 mg/m^2 are not
allowed. A complete cycle comprises 4 doses of bortezomib. Dexamethasone will be first
introduced in Cycles 1 to 5 (i.e.dexamethasone will not be introduced for the first time in
Cycles 6 to 8). The median total dose of dexamethasone received per cycle ranges from 120 mg
(cycle 7) to 160 mg (cycles 1 to 6 and 8). Efficacy will be primarily assessed by
determining Best Confirmed Response according to the European Group for Blood and Marrow
Transplantation (EBMT) criteria. Participant's safety will be monitored throughout the
study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best Confirmed Response to Bortezomib Re-Treatment
Number of participants with best confirmed response to bortezomib Re-Treatment will be assessed by the European Group for Blood and Marrow Transplantation (EBMT) criteria. Best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. The ordering of possible responses are Complete Response (CR), Partial Response (PR), Minimal Response (MR), No Change (NC) and Progressive Disease (PD)/relapse from CR. CR is the best response and the poorest response is PD or relapse from CR.
Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)
No
Janssen-Cilag International NV Clinical Trial
Study Director
Janssen-Cilag International NV
Belgium: Ministry of Social Affairs, Public Health and the Environment
CR010519
NCT00431769
June 2006
January 2010
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