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

NCT01472627 | Completed DMC

• 1 other identifier: 10-272
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Keywords

MM; Bortezomib; Velcade

Outcome Measures

Primary Outcomes (1)

• Effect of bortezomib on circulating dendritic cell and T cell populations

  Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy

  2 years

Study Arms (1)

Bortezomib treatment

Subjects receiving standard of care regimen including Bortezomib

Procedure: Blood draws

Interventions

Blood draws PROCEDURE

Blood draws

Bortezomib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Receiving standard of care treatment with a regimen containing bortezomib at Beth Israel Medical Center or Dana-Farber Cancer Institute

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples, bone marrow

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

US (2)