Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma

This is an expanded access trial for Multiple Myeloma focused on measuring 213304, belantamab mafodotin, Expanded Access Program, Multiple Myeloma Read More

Individual Patient IND:

INCLUSION CRITERIA:

1. Written informed consent

2. Diagnosis of RRMM and/or plasma cell dyscrasias and:

   1. Has failed 4 prior therapies
   2. Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38 antibody (alone or in combinations if available)
3. Disease Progression on last therapy
4. Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment cycles and as clinically indicated
5. 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

EXCLUSION CRITERIA:

1. Evidence of Active Bleeding
2. Currently Active GVHD
3. Known Hypersensitivity to the active substance or to any of the excipients
4. Previous progression on belantamab mafodotin

US Expanded Access (group) Protocol:

INCLUSION CRITERIA:

For patients currently receiving BLENREP through the REMS program

1. Patients currently enrolled in the BLENREP REMS program who have received at least 1 dose of BLENREP

2. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations

   For new patients

3. 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
4. No other treatment options available
5. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations

EXCLUSION CRITERIA:

For patients currently receiving BLENREP through the REMS program

1. Previously progressed on treatment with belantamab mafodotin.
2. Patient is pregnant or breastfeeding

For new patients

1. Previously progressed on treatment with belantamab mafodotin.
2. Patient is pregnant or breastfeeding