Clinical Trial 22449

• Overview

  Study 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

  Summary:

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

  Objective:

  To provide expanded access to belantamab mafodotin prior to FDA approval for RRMM patients who do not benefit for approved standard therapies, do not qualify for ongoing belantamab mafodotin clinical trials, and have no suitable alternative treatment options.

• Inclusion Criteria

  Inclusion Criteria: Individual Patient IND:
  • Written informed consent.
  • Diagnosis of RRMM and/or plasma cell dyscrasias and: Has failed 4 prior therapies Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38 antibody (alone or in combinations if available)
  • Disease Progression on last therapy
  • Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment cycles and as clinically indicated
  • 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. Inclusion Criteria for patients currently receiving BLENREP through the REMS program:
  • Patients currently enrolled in the BLENREP REMS program who have received at least 1 dose of BLENREP
  • Written informed consent can be obtained from the patient or legally authorized representative as per local regulations. For new patients
  • 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.
  • No other treatment options available
  • Written informed consent can be obtained from the patient or legally authorized representative as per local regulations.

• Exclusion Criteria

  Exclusion Criteria: Individual patient IND:
  • Evidence of Active Bleeding
  • Currently Active GVHD
  • Known Hypersensitivity to the active substance or to any of the excipients.
  • Previous progression on belantamab mafodotin US Expanded Access (group): For patients currently receiving BLENREP through the REMS program
  • Previously progressed on treatment with belantamab mafodotin.
  • Patient is pregnant or breastfeeding. For new patients:
  • Previously progressed on treatment with belantamab mafodotin.
  • Patient is pregnant or breastfeeding

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