Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma
Conditions: Keywords
MM, Bortezomib, Velcade
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Blood draws
Type: Procedure
Overall Status
Recruiting
Summary
The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Start Date
October 2010
Sponsors
Beth Israel Deaconess Medical Center
Source
Dana-Farber Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page