Expanded Access Request Program for Belantamab Mafodotin in Multiple Myeloma EXPANDED ACCESS REQUEST FOR BELANTAMAB MAFODOTIN

What's the purpose of this trial?

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

This trial is currently open and accepting patients.


What will happen during the trial?

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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Specific eligibility criteria must be met, these include:

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

INCLUSION CRITERIA:

  • Written informed consent
  • Diagnosis of multiple myeloma and/or plasma cell dyscrasias and either:
    • 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
    • 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.
  • Able to obtain ophthalmic examinations at baseline, before the next 3 subsequent treatment cycles and as clinically indicated on treatment
  • Contraception requirements
      • Female Participants: A female patient is eligible to participate if one of the following conditions applies:
        • 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.
        • 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:

  • If considering combination with bortezomib/dexamethasone intolerant or refractory to bortezomib. If considering combination with pomalidomide/dexamethasone intolerant or refractory to pomalidomide
  • Alanine transaminase (ALT) >2.5x upper limit of normal (ULN).
  • 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.
  • 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.
  • Patients with Hepatitis B will be excluded unless:
    • HbcAb positive, HBsAg negative: HBV deoxyribonucleic acid (DNA) undetectable and Antiviral treatment instituted if HBV DNA becomes detectable
    • HBsAg positive at screen or within 3 months prior to first dose: HBV DNA undetectable and Antiviral treatment maintained throughout program treatment
  • 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:
    • RNA test negative
    • Successful anti-viral treatment followed by a negative HCV RNA test after a washout period of at least 4 weeks
  • Evidence of Active Bleeding requiring intervention
  • Currently Active Graft-versus-host disease (GvHD)
  • Known Hypersensitivity to the active substance or to any of the excipients
  • Previous progression on belantamab mafodotin
  • Active infection requiring treatment
  • Previous participation in DREAMM-7 or DREAMM-8 clinical trials

Additional Trial Information

Expanded Access

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Trial Resources

GSK Compassionate Use (Expanded Access) Request Portal

December 22, 2024

GSK recognises that there may be circumstances when it is appropriate for Healthcare Professionals to give their patients Investigational medicines to treat life threatening or seriously debilitating diseases/conditions where no satisfactory alternatives exist.

Learn more

Trial Links

Read the latest news and updates on this trial.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14, 2020

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Read more
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