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OpenTrials
Completed

NCT Number: NCT01472627

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

The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draws

Procedure

Blood draws

Primary outcomes

  1. Effect of bortezomib on circulating dendritic cell and T cell populations

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2011
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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