Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds specifically to B-Cell Maturation Antigen. This program is intended to provide access to belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). Patients considering this access program should have no other therapeutic option, and not eligible for other clinical trials.
Compassionate use program (209233): Additional Criteria: patients must have failed at least three lines of above stated prior therapy and should also be ineligible for all currently approved standard of care for 4L+ MM in the requesting country.
The Expanded Access program (213304) is currently only available in the United States only. The Individual Patient program (209233) is available in countries other than the United States.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
Adequate organ system functions.
Criteria for Determining Adequate Organ System Function:
Lab Parameter -- Laboratory Values Absolute Neutrophil count -- (ANC) / ≥ 1.0 X 109/L Hemoglobin -- ≥ 7.0 g/dL Platelets -- ≥ 50 X 109/L Total bilirubin -- ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) ALT -- ≤2.5 X ULN or <5 times ULN if documented liver infiltration eGFR (as calculated MDRD equation) -- ≥ 30 mL/min/ 1.73 m2
Contraception:
- Female Participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
-
Is not a woman of childbearing potential (WOCBP) OR
-
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 80 days after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The physician should evaluate the effectiveness of the contraceptive method in relationship to the first dose of belantamab mafodotin.
A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of belantamab mafodotin.
The physician is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Male Participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 140 days after last dose of belantamab mafodotin:
• Refrain from donating sperm
PLUS either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
• Must agree to use contraception/barrier as detailed below: Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
Exclusion Criteria:
-
Evidence of active bleeding requiring intervention within the last four weeks.
-
Current corneal epithelial disease except changes in corneal epithelium.
-
Any major surgery within the last four weeks.
-
Prior allogeneic stem cell transplant (SCT). Exception: syngeneic transplant
-
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.
-
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.
-
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.
-
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.
-
Evidence of cardiovascular risk including any of the following:
-
QTcF interval ≥480 msecs (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF])
-
Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
-
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of first dose.
-
Class III or IV heart failure as defined by the New York Heart Association functional classification system
-
Uncontrolled hypertension
-
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin.
-
Active infection requiring antibiotic, antiviral, or antifungal treatment.
-
Known HIV infection.
-
Presence of hepatitis B surface antigen (HBsAg), at or within 3 months prior to request for belantamab mafodotin under compassionate use.
-
Positive hepatitis C antibody test result or positive hepatitis C RNA test result at or within 3 months prior to request for belantamab mafodotin under compassionate use.
Note: Positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
213304: Additional Criteria:
Inclusion Criteria:
-
Written informed consent can be obtained from the patient or legally authorized representative as per local regulations
-
Histologically or cytologically confirmed diagnosis of MM as defined according to IMWG, 2016 criteria, and
-
has undergone stem cell transplant or is considered transplant ineligible, and
-
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).
-
Male or female, 18 years or older (at the time consent is obtained)
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
-
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
- All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Event (NCI-CTCAE) must be ≤ Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy.
213304: Additional Criteria:
Exclusion Criteria:
-
Prior allogeneic stem cell transplant (SCT). Exception: syngeneic transplant, if no history of or currently active graft versus host disease.
-
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.
-
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.
-
Previously progressed on treatment with belantamab mafodotin
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 209233