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Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02666209
Expanded Access Status : No longer available
First Posted : January 28, 2016
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date January 22, 2016
First Posted Date January 28, 2016
Last Update Posted Date August 28, 2017
 
Descriptive Information
Brief Title Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
Brief Summary Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657
Detailed Description

This research study is an Expanded Access Trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available.

The purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab.

Participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. Ulocuplumab is supposed to kill myeloma cells.

Lenalidomide, which is also known as Revlimid® and Bortezomib, which is also known as Velcade®, are approved by the FDA for treatment of Multiple Myeloma. Dexamethasone, also known as Decadron®, is also approved by the FDA for other treatments. It is a type of steroid medication that fights inflammation.

Study Type Expanded Access
Intervention
  • Drug: Ulocuplumab
    CXCR4 inhibitor given weekly on a 28 day cycle intravenously
    Other Name: BMS-936564
  • Drug: Lenalidomide
    immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib
    Other Name: Revlimid
  • Drug: Bortezomib
    proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide
    Other Name: Velcade
  • Drug: Dexamethasone
    steroid given at physician discretion on a 28 day cycles
    Other Name: Decadron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02666209
Responsible Party Irene Ghobrial, MD, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators Bristol-Myers Squibb
Investigators
Principal Investigator: Irene M Ghobrial, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date August 2017