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

December 16, 2022 updated by: GlaxoSmithKline

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

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

Study Overview

Detailed 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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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