NCT02666209

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ulocuplumab	CXCR4 inhibitor given weekly on a 28 day cycle intravenously
DRUG	Lenalidomide	immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib
DRUG	Bortezomib	proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide
DRUG	Dexamethasone	steroid given at physician discretion on a 28 day cycles

Timeline

• First posted: 2016-01-28
• Last updated: 2017-08-28

Locations

1 site across 1 country: United States