Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma. You can access GSK's Compassionate Use (Expanded Access) Request Portal via https://gsk-cu-portal.idea-point.com.
This expanded access protocol was designed to allow access to belantamab mafodotin for RRMM who meet these criteria.
GSK2857916 will be administered intravenously to participants at the site.
Administration will be documented in the source documents and reported in the eCRF.
Study treatment is based on body weight calculation and may be reduced for toxicity for
individual participants according to protocol guidelines.
Participants will receive study treatment at the site directly from the investigator or
designee, under medical supervision. The date, time and dose strength of each dose
administered in the clinic will be recorded in the source documents and reported in the
eCRF. The dose of study treatment and study participant identification will be confirmed
at the time of dosing by a member of the study site staff other than the person
administering the study treatment and documented in source.
Baptist MD Anderson Cancer Center
1.Written informed consent can be obtained from the patient or legally authorized representative as per local regulations
2.Histologically or cytologically confirmed diagnosis of MM as defined according to IMWG, 2016 criteria, and
a.has undergone stem cell transplant or is considered transplant ineligible, and
b.is refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an IMiD (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib).
3.Male or female, 18 years or older (at the time consent is obtained)
4.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5.Patients with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
a, transplant was >100 days prior to study enrollment b. no active infection(s) c.. participant meets the remainder of the eligibility criteria outlined in this protocol
1.Evidence of active bleeding requiring intervention within the last four weeks.
2.Current corneal epithelial disease except changes in corneal epithelium.
3.Any major surgery within the last four weeks.
4.Prior allogeneic stem cell transplant (SCT). Exception: syngeneic transplant
5.Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria given in Inclusion #1.
6.Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety or compliance to the procedures.
7.Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
8.Malignancies other than disease under study are excluded, except for any other malignancy from which the participant is not being actively treated with cytotoxic chemotherapy and/or radiation within 5 ½ half-lives, or 14 days, whichever is shorter. Hormonal Therapy for disease is acceptable.
1.Prior allogeneic stem cell transplant (SCT). Exception: syngeneic transplant, if no history of or currently active graft versus host disease.
2.Best corrected visual acuity in the worst seeing eye worse than 20/100 (Snellen equivalent). Participants with vision worse than 20/100 due to a treatable condition (e.g., cataract) may be considered on an individual case basis.
3.Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
4.Previously progressed on treatment with belantamab mafodotin