Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro

Completed

• Conditions: Multiple Myeloma
• Interventions: Procedure: Blood draws

• Registration Number: NCT01472627
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-11-11
• Study First Posted: 2011-11-16
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bortezomib treatment	Blood draws	Subjects receiving standard of care regimen including Bortezomib

Primary Outcome Measures

Name	Time	Method
Effect of bortezomib on circulating dendritic cell and T cell populations	2 years	Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States