Managed Access Program for Combination Treatment With Belantamab Mafodotin in Multiple Myeloma

October 11, 2024 updated by: GlaxoSmithKline

Managed Access Program for Belantamab Mafodotin in Combination With Either Bortezomib/Dexamethasone or Pomalidomide/Dexamethasone in Patients With Multiple Myeloma Previously Treated With at Least 1 Prior Line of Therapy

Compassionate use access to belantamab mafodotin (GSK2857916) (in combination with bortezomib/dexamethasone or pomalidomide/dexamethasone) for eligible participants with multiple myeloma previously treated with at least 1 prior line of therapy.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) comprised of an afucosylated, humanized Immunoglobulin G1 (IgG1) monoclonal immunoconjugate that binds specifically to B-Cell Maturation Antigen. This program is intended to provide access to belantamab mafodotin (in combination with bortezomib/dexamethasone or pomalidomide/dexamethasone) in patients with Multiple Myeloma (MM) who have received at least 1 prior therapy for multiple myeloma, and whose treating physicians have determined that there is unmet treatment need.

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.

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

Specific eligibility criteria must be met, these include:

  1. There is no satisfactory alternative treatment for the patient including approved standard of care treatments for their multiple myeloma; and
  2. There is reason to believe that the benefit to the patient using belantamab mafodotin outweighs the risk
  3. Patient does not qualify for, or is unable to participate in, other ongoing clinical trials

INCLUSION CRITERIA:

  1. Written informed consent

  2. Diagnosis of multiple myeloma and/or plasma cell dyscrasias and either:

    1. For combination with bortezomib/dexamethasone; previously treated with at least 1 prior line of MM therapy and must have documented disease progression during or after their most recent therapy OR
    2. For combination with pomalidomide/dexamethasone; have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles) and must have documented disease progression during or after their most recent therapy.
  3. Able to obtain ophthalmic examinations at baseline, before the next 3 subsequent treatment cycles and as clinically indicated on treatment
  4. 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 Cycle 1 Day 1. 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. If considering combination with bortezomib/dexamethasone intolerant or refractory to bortezomib. If considering combination with pomalidomide/dexamethasone intolerant or refractory to pomalidomide
  2. Alanine transaminase (ALT) >2.5x upper limit of normal (ULN).
  3. Total bilirubin >1.5xULN; patients with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is ≤1.5xULN.
  4. Cirrhosis or current unstable liver or biliary disease per physician assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice.

  5. Patients with Hepatitis B will be excluded unless:

    1. HbcAb positive, HBsAg negative: HBV deoxyribonucleic acid (DNA) undetectable and Antiviral treatment instituted if HBV DNA becomes detectable
    2. HBsAg positive at screen or within 3 months prior to first dose: HBV DNA undetectable and Antiviral treatment maintained throughout program treatment

  6. Patients with positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of program treatment unless:

    1. RNA test negative
    2. Successful anti-viral treatment followed by a negative HCV RNA test after a washout period of at least 4 weeks
  7. Evidence of Active Bleeding requiring intervention
  8. Currently Active Graft-versus-host disease (GvHD)
  9. Known Hypersensitivity to the active substance or to any of the excipients
  10. Previous progression on belantamab mafodotin
  11. Active infection requiring treatment
  12. Previous participation in DREAMM-7 or DREAMM-8 clinical trials

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

GlaxoSmithKline

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.

Helpful Links

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)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209233

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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