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

Clinical Trial Details

The purpose of this study is to provide men and women with relapsed/refractory multiple myeloma (RRMM) expanded access to the antibody-drug conjugate belantamab mafodotin.

This study is open to those who are either enrolled in the BLENREP REMS (Risk Evaluation and Mitigation Strategy) program, or who have RRMM refractory to immunomodulators (IMID), proteasome inhibitors (PI), and an anti-CD38 antibody, and no suitable alternative treatment options.

Belantamab mafodotin is considered investigational which means it is not yet approved by the U.S. Food and Drug Adminstration (FDA).

Participants will receive belantamab mafodotin intravenously (through a needle in the vein) over at least 30 minutes once every three weeks.

Participation in this research will last as long as participants continue to benefit.

Key Eligibility:

Open to men and women currently enrolled in the BLENREP REMS program who have received at least 1 dose of BLENREP.
Open to men and women diagnosed with RRMM who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Participants must not be pregnant or breastfeeding.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Janiece Francis
646-962-6500
jaf9126@med.cornell.edu

Primary Investigator(s)

Ruben Niesvizky, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2304025914

ClinicalTrials.gov:

NCT03763370

Status

Open to Enrollment

Age Group

Adult

Disease

Multiple Myeloma