Status:
UNKNOWN
VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)
Lead Sponsor:
University of Wuerzburg
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple mye...
Detailed Description
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE in patients with multiple myeloma with det...
Eligibility Criteria
Inclusion
- Patient having received tandem transplants with high-dose melphalan and autologous PBSCT within 3-6 months prior to inclusion into this protocol
- Patients with measurable minimal residual disease (very good partial remission \[VGPR\]) or patients in partial remission (PR) or patients with stable disease (SD) at the time of inclusion in the study
- Patient must agree to participate in the study.
- Patient agrees to use an appropriate method of contraception.
- Willingness and ability to comply with the study protocol for the duration of the study
Exclusion
- Patient showing signs of disease progression
- Patient has a platelet count \< 100 x 10\^9/L within 14 days before enrollment.
- Patient has an absolute neutrophil count \< 1.0 x 10\^9/L within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance \< 30 mL/minute within 14 days before enrollment.
- Patient has \>= Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has hypersensitivity to bortezomib, boron, or mannitol.
- Patient has received prior treatment with bortezomib
- Patient is pregnant or nursing
- Patient has received other investigational drugs within 14 days before enrollment
- Patient has progressive disease
- Patient has a Karnofsky performance status \< 60%
- Patient has a life expectancy of \< 3 months
- Patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids
- Patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00311337
Start Date
October 1 2005
End Date
October 1 2010
Last Update
April 5 2006
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Univ.-Klinik Graz
Graz, Austria, 8036
2
Klin. Abt. für Onkologie, AKH Wien
Vienna, Austria, 1090
3
Dept. of Hematology/Oncology, Charité Berlin
Berlin, Germany, 10098
4
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, Germany, 80336