Last updated: 10/11/2024 16:00:11
Managed Access Program for combination treatment with belantamab mafodotin in multiple myeloma
GSK study ID
209233
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Available
Available
Trial overview
Official title: Managed Access Program for belantamab mafodotin in combination with either bortezomib/dexamethasone or pomalidomide/dexamethasone in patients with multiple myeloma previously treated with at least 1 prior line of therapy
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1000
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Expanded Access
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- 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
Inclusion and exclusion criteria
Inclusion 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: a. 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 b. 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: a. HbcAb positive, HBsAg negative: HBV deoxyribonucleic acid (DNA) undetectable and Antiviral treatment instituted if HBV DNA becomes detectable b. 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: a. RNA test negative b. 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Not applicable
Results overview
Not applicable
Recruitment status
Available
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable
Additional information about the trial
Participate in clinical trial
Additional information
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.
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