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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd) | Drug | Drug: Belantamab mafodotin •Belantamab mafodotin 2.5 milligram per kilogram (mg/kg) intravenous (IV) will be administered at every cycle, once every 3 Weeks, on Day 1 of every cycle, until completion of treatment. Drug: Bortezomib •Bortezomib will be administered based on the full prescribing information, for the first 8 Cycles Drug: Dexamethasone •Dexamethasone will be administered based on the full prescribing information, for the first 8 Cycles | ||
| Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd) | Drug | Drug: Belantamab mafodotin:
Drug: Pomalidomide •Pomalidomide will be administered at every cycle, based on the full prescribing information Drug: Dexamethasone •Dexamethasone will be administered at every cycle, based on the full prescribing information |
Specific eligibility criteria must be met, these include:
INCLUSION CRITERIA:
Written informed consent
Diagnosis of multiple myeloma and/or plasma cell dyscrasias and either:
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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Label | URL |
|---|---|
| If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal. | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000631691 | belantamab mafodotin |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |