Managed Access Program for Combination Treatment with Belantamab Mafodotin for Multiple Myeloma

Sponsor: GlaxoSmithKline

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03763370

Provider View

This program offers access to a new treatment option, belantamab mafodotin, combined with other medications for patients with multiple myeloma who have already tried at least one other treatment.

Patient Parameters

Program Overview

This program provides access to a treatment called belantamab mafodotin, which is used in combination with other drugs like bortezomib/dexamethasone or pomalidomide/dexamethasone. It is intended for patients with multiple myeloma who have already received at least one previous treatment and still need additional options. Belantamab mafodotin is a type of drug that targets specific proteins on cancer cells to help fight the disease.

Description

Belantamab mafodotin is a specialized treatment that combines an antibody with a drug to target and attack cancer cells in multiple myeloma. This program allows patients who have already tried other treatments to access belantamab mafodotin in combination with other medications like bortezomib/dexamethasone or pomalidomide/dexamethasone. The goal is to provide another option for patients whose doctors believe they need more treatment choices. Patients will need to meet certain health criteria and agree to regular eye exams and use of contraception if applicable.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent to participate.
  • Have a diagnosis of multiple myeloma or related conditions.
  • For treatment with bortezomib/dexamethasone: Must have tried at least one previous treatment and have worsening disease.
  • For treatment with pomalidomide/dexamethasone: Must have tried at least one previous treatment including lenalidomide and have worsening disease.
  • Must be able to have eye exams before and during treatment.
  • Must agree to use effective birth control if of childbearing potential.
  • Women must have a negative pregnancy test before starting treatment.
  • Men must agree to use birth control if their partner is of childbearing potential.

Exclusion Criteria

  • Cannot use bortezomib/dexamethasone if intolerant or resistant to bortezomib.
  • Cannot use pomalidomide/dexamethasone if intolerant or resistant to pomalidomide.
  • Liver enzyme levels too high.
  • Severe liver disease or cirrhosis.
  • Active hepatitis B or C infection unless controlled with treatment.
  • Active bleeding issues.
  • Active graft-versus-host disease.
  • Allergy to belantamab mafodotin or its ingredients.
  • Previous progression on belantamab mafodotin.
  • Active infection needing treatment.
  • Previous participation in specific clinical trials (DREAMM-7 or DREAMM-8).

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