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

Last updated: August 25, 2017
Sponsor: Dana-Farber Cancer Institute
Overall Status: Trial Not Available

Phase

N/A

Condition

Platelet Disorders

Lymphoproliferative Disorders

Cancer

Treatment

N/A

Clinical Study ID

NCT02666209
16-002
CA212-122
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent document

  • Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), toleratingtherapy, and still receiving benefit from treatment.

Exclusion

Exclusion Criteria:

  • Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocolCA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days;antibody against CXCR4 within 10 weeks).

Study Design

Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

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