Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02666209|
Expanded Access Status : No longer available
First Posted : January 28, 2016
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment|
|Multiple Myeloma in Relapse Multiple Myeloma||Drug: Ulocuplumab Drug: Lenalidomide Drug: Bortezomib Drug: Dexamethasone|
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|
|Official Title:||Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma|
- Drug: Ulocuplumab
CXCR4 inhibitor given weekly on a 28 day cycle intravenouslyOther Name: BMS-936564
- Drug: Lenalidomide
immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomibOther Name: Revlimid
- Drug: Bortezomib
proteasome inhibitor given at physician discretion in subjects not receiving lenalidomideOther Name: Velcade
- Drug: Dexamethasone
steroid given at physician discretion on a 28 day cyclesOther Name: Decadron
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666209
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Irene M Ghobrial, MD||Dana-Farber Cancer Institute|