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

Primary Purpose

Multiple Myeloma in Relapse, Multiple Myeloma

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Ulocuplumab
Lenalidomide
Bortezomib
Dexamethasone
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Multiple Myeloma in Relapse focused on measuring Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Signed informed consent document
  • Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment.

Exclusion Criteria:

  • Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).

Sites / Locations

  • Dana Farber Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 22, 2016
Last Updated
August 25, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02666209
Brief Title
Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
Official Title
Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma in Relapse, Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ulocuplumab
Other Intervention Name(s)
BMS-936564
Intervention Description
CXCR4 inhibitor given weekly on a 28 day cycle intravenously
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
steroid given at physician discretion on a 28 day cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Signed informed consent document Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment. Exclusion Criteria: Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene M Ghobrial, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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