Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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 — Status: Available

Administrative data

• NCT number: NCT03763370
• Other study ID #: 209233
• Status: Available

Study information

• Verified date: December 2022
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma

Description:

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. US patients who have been treated through the REMS program are eligible to enroll in this program.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Individual Patient IND:

INCLUSION CRITERIA:

1. Written informed consent

2. Diagnosis of RRMM and/or plasma cell dyscrasias and:

1. Has failed 4 prior therapies

2. Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38 antibody (alone or in combinations if available)

3. Disease Progression on last therapy

4. Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment cycles and as clinically indicated

5. Contraception requirements

A. Female Participants: A female patient is eligible to participate if one of the following conditions applies:

I. The patient Is not a woman of childbearing potential (WOCBP)OR II. The patient Is a WOCBP and using an effective contraceptive method during treatment with belantamab mafodotin and for 4 months after the last dose. The patient must also have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Please discuss with GSK physician if the patient is pregnant, breast-feeding or planning to have a baby.

B. Male participants with female partners of child-bearing potential are eligible to participate if they agree to use effective contraception during treatment with belantamab mafodotin until 6 months after the last dose

EXCLUSION CRITERIA:

1. Evidence of Active Bleeding

2. Currently Active GVHD

3. Known Hypersensitivity to the active substance or to any of the excipients

4. Previous progression on belantamab mafodotin

US Expanded Access (group) Protocol:

INCLUSION CRITERIA:

For patients currently receiving BLENREP through the REMS program

1. Patients currently enrolled in the BLENREP REMS program who have received at least 1 dose of BLENREP

2. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations

For new patients

3. New patients diagnosed with RRMM who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent

4. No other treatment options available

5. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations

EXCLUSION CRITERIA:

For patients currently receiving BLENREP through the REMS program

1. Previously progressed on treatment with belantamab mafodotin.

2. Patient is pregnant or breastfeeding

For new patients

1. Previously progressed on treatment with belantamab mafodotin.

2. Patient is pregnant or breastfeeding

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate
Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

External Links

•   If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal.