Study on the Reduction of Tumor Cell Burden With Bortezomib (Vel), Cyclophosphamide (C) and Dexamethasone (D) Before Stem Cell Transplantation (So-called Induction Therapy) in Patients With Multiple Myeloma Aged 60 Years or Less.
The purpose of this clinical study is to investigate 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.
Stem Cell Transplantation
Drug: Cyclophosphamide (Cy)
Drug: Bortezomib (Btz)
Drug: Dexamethasone (D)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Efficacy (Response) [ Time Frame: efficacy of response after every one of three cycles ] [ Designated as safety issue: No ]
- Tolerability and comparison of response rates in different cytogenetic risk groups [ Time Frame: efficacy of response after every one of three cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Bortezomib (Btz) Btz 1.3 mg/m2 intravenously Day 1,4,8,11 of each 21 day cycle for 3 cycles
Drug: Cyclophosphamide (Cy)
Cy 900mg as intravenous infusion on Day 1 of each 21 day cycle for 3 cyclesDrug: Bortezomib (Btz)
Btz 1.3 mg/m2 intravenously Day 1,4,8,11 of each 21 day cycle for 3 cyclesDrug: Dexamethasone (D)
D 40 mg tablet Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21 day cycle for 3 cycles
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.