Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
NCT ID: NCT01472627
Last Updated: 2018-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11 participants
OBSERVATIONAL
2010-10-31
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Bortezomib treatment
Subjects receiving standard of care regimen including Bortezomib
Blood draws
Blood draws
Interventions
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Blood draws
Blood draws
Eligibility Criteria
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Inclusion Criteria
* Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the standard of care therapy for myeloma by their treating physician
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Jacalyn Rosenblatt, MD
Principal Investigator
Principal Investigators
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Jacalyn Rosenblatt, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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10-272
Identifier Type: -
Identifier Source: org_study_id
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