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

GlaxoSmithKline (GSK)

Status

Conditions: Multiple Myeloma

Treatments: Drug: Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd); Drug: Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03763370

209233

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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