Phase II/III Study for Remission Induction With Bortezomib (Vel), Cyclophosphamide (C) and Dexamethasone (D) in Patients <= 60 Years With Untreated Multiple Myeloma and Planned High Dose Chemotherapy: (VelCD)
Today high dose chemotherapy (HD-CT) with stem cell support is considered the standard for
younger patients with multiple myeloma. The standard protocol for induction therapy before
HD-CT is a combination therapy consisting of vincristine, adriamycin and dexamethasone. 40%
of the patients do not respond to conventional induction therapy. With the combination of
bortezomib and cyclophosphamide, a potent cytotoxic substance already in use against
multiple myeloma, an increased efficacy is expected. In this prospective, open-label,
single arm, multi-center study, induction therapy for remission with bortezomib,
cyclophosphamide and dexamethasone in patients aged 60 years and younger with multiple
myeloma planned for high-dose chemotherapy with stem cell transplantation is investigated.
In the first part an evaluation of an optimal dose of cyclophosphamide if combined with a
fixed bortezomib and dexamethasone dose is done and in the second part, efficacy and
tolerance of the assessed dose is evaluated. Primary outcome of the second part is response
prior to high dose chemotherapy. The first part (dose definition) has already been
completed.On the days patients receive bortezomib, vital signs and blood tests and, at the
first day of each cycle, a physical examination will be performed. Adverse events are to be
documented and reported during the study in accordance with ICH-GCP guidelines. 400 male and
female patients with untreated Multiple Myeloma are to be included in this study. In the
first part of the study, the number of patients was restricted to 30. Thus, approximately
370 patients were to be included in the second part. Bortezomib 1,3 mg/m2 by intravenous
bolus on Day 1, 4, 8, and 11 for a maximum of 3 cycles. One cycle consists of 21 days.
Cyclophosphamide 900mg as intravenous infusion on Day 1 of each cycle. Dexamethasone 40 mg
on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy (Response)
efficacy of response after every one of three cycles
No
Janssen-Cilag G.m.b.H. Clinical Trial
Study Director
Janssen-Cilag G.m.b.H
Germany: Federal Institute for Drugs and Medical Devices
CR005242
NCT00833560
March 2006
June 2009
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