Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment blood draws
Target proteasome
Sponsor Beth Israel Deaconess Medical Center
Start date October 2010
End date October 2017
Trial size 20 participants
Trial identifier NCT01472627, 10-272

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Subjects receiving standard of care regimen including Bortezomib
blood draws
Blood draws

Primary Outcomes

Measure
Effect of bortezomib on circulating dendritic cell and T cell populations
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Principal investigator Jacalyn Rosenblatt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.