Overview

VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

Status:
Unknown status
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
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 myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wuerzburg
Treatments:
Bortezomib
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.