An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant
This is an open-label (patients will know the identity of study treatments), randomized
(patients will be assigned by chance to different treatments) study of bortezomib
administered as consolidation therapy (therapy given once a remission is achieved) with
thalidomide and prednisolone versus thalidomide and prednisolone alone in previously
untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells,
a type of white blood cell present in your bone marrow. Patients in this study will receive
initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD
induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure
where patients receive an infusion of immature blood cells [stem cells] from their own body
to replenish the body's supply of healthy blood-forming cells) before randomization to one
of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression
and prednisolone on alternate days continued indefinitely or until disease progression) or
Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until
disease progression and prednisolone on alternate days, continued indefinitely or until
disease progression.
Throughout the study, the patient's response to therapy will be assessed according to
protocol-defined efficacy evaluations and by implementing defined disease response criteria
(International Myeloma Working Group [IMWG] criteria). Safety will be evaluated throughout
the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be
conducted from time of randomization to 3 years post-randomization.
Two interim analyses are planned. The final analysis will be conducted after all patients
have completed 12-month consolidation treatment phase or discontinued. The primary endpoint
of number and percent of patients with complete response and very good partial response
defined by IMWG criteria for multiple myeloma will be examined in the interim and final
analyses after approximately 12 months of consolidation therapy. At the completion of the
study, updated analyses of PFS and OS will be performed.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The number and percent of patients with complete response (CR) + very good partial response (VGPR)
After approximately 12 months of consolidation therapy
No
Janssen Asia-Pacific Medical Affairs Clinical Trial
Study Director
Janssen Asia-Pacific Medical Affairs
Australia: National Health and Medical Research Council
CR018751
NCT01539083
January 2012
November 2017
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