Status:
AVAILABLE
Managed Access Program for Combination Treatment With Belantamab Mafodotin in Multiple Myeloma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
Compassionate use access to belantamab mafodotin (GSK2857916) (in combination with bortezomib/dexamethasone or pomalidomide/dexamethasone) for eligible participants with multiple myeloma previously tr...
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 Matu...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03763370
Last Update
October 15 2024
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