Multiple MyelomaNCT03763370
Managed Access Program for Combination Treatment With Belantamab Mafodotin in Multiple Myeloma
A study testing Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd) and Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd) in people with Multiple Myeloma, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd) and Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Written informed consent
- Diagnosis of multiple myeloma and/or plasma cell dyscrasias and either:
- 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
- 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.
- Able to obtain ophthalmic examinations at baseline, before the next 3 subsequent treatment cycles and as clinically indicated on treatment
- Contraception requirements
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- Female Participants: A female patient is eligible to participate if one of the following conditions applies:
- 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.
- 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
Who cannot join
- 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:
- HbcAb positive, HBsAg negative: HBV deoxyribonucleic acid (DNA) undetectable and Antiviral treatment instituted if HBV DNA becomes detectable
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- HBsAg positive at screen or within 3 months prior to first dose: HBV DNA undetectable and Antiviral treatment maintained throughout program treatment
- 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:
- RNA test negative
- Successful anti-viral treatment followed by a negative HCV RNA test after a washout period of at least 4 weeks
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd), Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd)
- Keywords
- 213304, belantamab mafodotin, Bortezomib, Dexamethasone, Pomalidomide, Expanded Access Program, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Cycle 1: Belantamab mafodotin 2.5 mg/kg IV administered once
- Cycle 2 onward: Belantamab mafodotin 1.9 mg/kg IV administered once every 4 weeks until completion of treatment
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763370
- Sponsor's protocol ID
- 209233
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2018
- Last updated
- 15 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03763370
- Acronym / sponsor ID
- 209233
- Conditions
- Multiple Myeloma
- Keywords
- 213304, belantamab mafodotin, Bortezomib, Dexamethasone, Pomalidomide, Expanded Access Program, Multiple Myeloma
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Female Participants: A female patient is eligible to participate if one of the following conditions applies:
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd)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 | Drug | – |
| Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd)Drug: Belantamab mafodotin: * Cycle 1: Belantamab mafodotin 2.5 mg/kg IV administered once * Cycle 2 onward: Belantamab mafodotin 1.9 mg/kg IV administered once every 4 weeks until completion of treatment 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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A study testing Belantamab mafodotin 2.5 mg/kg IV Q3Weeks + Vd (BVd) and Belantamab mafodotin 2.5/1.9 mg/kg IV Q4Weeks + Pd (BPd) in people with Multiple Myeloma, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.