This study involves a randomized Phase II, window of opportunity study of Bryostatin 1 followed by treatment with VAD 9Vincristine, Adriamycin and Decadron) in previously untreated patients with multiple myeloma. The primary objectives are: 1. To seek preliminary evidence of therapeutic activity of Bryostatin 1 when administered as a continuous IV infusion, either over 72 hours every two weeks or for 24 hours every week in patients with multiple myeloma. 2. To describe and quantitate the toxicity of Bryostatin 1 administered intravenously as a continuous infusion, either over 72 hours every two weeks or for 24 hours every week in patients with multiple myeloma. The secondary objects are: 1. To obtain preliminary data regarding the effect and toxicity of VAD when administered after Bryostatin 1. 2. to assess steady state concentrations of Bryostatin 1 during course one of therapy, using a bioassay. 3. To evaluate T lymphocyte subsets before and during Bryostatin 1 infusions. 4. To measure serum interleukin-6 (IL-6) levels pre and post administration of Bryostatin 1 during the first cycle. 5. Attempt to isolate malignant plasma cells from the bone marrow of patients, before treatment, to evaluate the effect of Bryostatin 1 on myeloma cell viability, cyclin-dependent kinase 2 expression and activation, and cytokine production.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000052-38S2
Application #
6264075
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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