Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03763370|
Expanded Access Status : Available
First Posted : December 4, 2018
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: GSK2857916 anti-BCMA-immunoconjugate|
belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds specifically to B-Cell Maturation Antigen. This program is intended to provide access to belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). Patients considering this access program should have no other therapeutic option, and not eligible for other clinical trials.
Compassionate use program (209233): Additional Criteria: patients must have failed at least three lines of above stated prior therapy and should also be ineligible for all currently approved standard of care for 4L+ MM in the requesting country.
The Expanded Access program (213304) is currently only available in the United States only. The Individual Patient program (209233) is available in countries other than the United States.
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients, Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||209233: Compassionate Use Individual Request Program for Belantamab Mafodotin in Multiple Myeloma 213304: Expanded Access Program for Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma Who Are Refractory to a Proteasome Inhibitor, and an Immunomodulatory Agent, and an Anti-CD38 Antibody|
- Drug: GSK2857916 anti-BCMA-immunoconjugate
Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks
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): NCT03763370
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|