Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Subjects on this study will be receiving treatment for multiple myeloma according to the
standard of care with a regimen containing Bortezomib.
If a bone marrow sample is clinically indicated to guide treatment, an additional 1
tablespoon of the specimen will be obtained for further laboratory studies.
Approximately 3 tablespoons of blood will be taken for research purposes before therapy with
Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and
additional 3 tablespoons of blood will be taken for research purposes.
Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3
and 6 months after completing therapy.
This study also includes a medical record review.
Inclusion Criteria:
- Newly diagnosed multiple myeloma
- Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the
standard of care therapy for myeloma by their treating physician
Exclusion Criteria:
- Hypersensitivity to bortezomib, boron or mannitol
- Treatment with other investigational drugs within 28 days before enrollment
- Diagnosed or treated for another malignancy within 6 months of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Use of other myeloma directed therapy (except for dexamethasone) in combination with
bortezomib
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Effect of bortezomib on circulating dendritic cell and T cell populations
Outcome Description:
Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Jacalyn Rosenblatt, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Institutional Review Board
Study ID:
10-272
NCT ID:
NCT01472627
Start Date:
October 2010
Completion Date:
Related Keywords:
- Multiple Myeloma
- MM
- Bortezomib
- Velcade
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
