AmyloidosisPhase 2ALANISNCT07224672
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
A Phase 2 study testing Belantamab mafodotin, Cyclophosphamide and Bortezomib in people with Amyloidosis, run by GlaxoSmithKline at 16 sites in 3 countries.
Trial summary
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Belantamab mafodotin, Cyclophosphamide and Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 24 Jun 2026to 12 Jan 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is at least 18 years of age or the legal age of consent
- Has histologically confirmed newly diagnosed primary AL amyloidosis according to the following criteria:
- Presence of an amyloid-related systemic syndrome as per consensus guidelines.
- Positive amyloid staining by Congo red stain with green birefringence on polarized light microscopy in any tissue AND at least 1 of the following tests to confirm amyloid type as AL Characteristic appearance by electron microscopy or confirmatory immunohistochemistry or AL amyloidosis typing by mass spectrometric proteomic analysis of the amyloid deposits or amyloid-typing by immunofluorescence oEvidence of a monoclonal plasma cell proliferative disorder
- Measurable clonal disease as defined by at least 1 of the following:
- Serum monoclonal protein >=0.5 grams per deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation performed at central laboratory),
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- Involved serum FLC >=5.0 milligram per deciliter (mg/dL) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved light chain, FLC concentrations (dFLC) >=5 mg/dL.
- Not considered candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) as part of first line of therapy
- Is willing to use adequate contraception.
- Is capable of giving signed informed consent
- Has an Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- Has adequate hematologic, hepatic and renal function
Who cannot join
- Has a previous or current diagnosis of plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome or symptomatic multiple myeloma (MM), as per International Myeloma Working Group criteria for MM including the presence of lytic bone disease , plasmacytomas, or clonal BM plasma cells >=60%.
- Has Immunoglobulin M (IgM)-related AL amyloidosis.
- Has any form of non-AL amyloidosis, including wild type or mutated (Transthyretin amyloidosis [ATTR]) amyloidosis.
- Has evidence of significant cardiovascular (CV) conditions as specified below:
- New York Heart Association (NYHA) classification IIIb or IV heart failure.
- Heart failure that in the opinion of the investigator is caused by ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrected valvular disease and not primarily due to AL amyloidosis cardiomyopathy.
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- In-participant admission to a hospital for unstable angina or myocardial infarction within the last 3 months prior to screening or percutaneous cardiac intervention with recent stent within last 3 months prior to screening or coronary artery bypass grafting within the last 3 months prior to screening
- Participants with current evidence of clinically significant untreated arrhythmia(s), including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block.
- Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular nodal or sinoatrial nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillator is indicated but not placed (participants who do have a pacemaker/implantable cardioverter-defibrillator are allowed on the study).
- Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >450 millisecond (msec) or >480 msec for participants with bundle branch block. Participants who have a pacemaker may be included regardless of calculated QTc interval.
- Supine systolic blood pressure <90 millimeters of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of >20 mmHg despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion.
- Uncontrolled hypertension.
- Has Mayo stage 3B disease
- Has a current corneal epithelial disease except for mild punctate keratopathy.
- Has previous or concurrent malignancies other than AL amyloidosis, except for any other malignancy that has been considered medically stable for at least 2 yearsThe participant must not be receiving active therapy, other than hormonal therapy for this disease.
- Has major surgery within 2 weeks prior to the first dose of study interventions or has not recovered fully from surgery.
- Has any history of prior allogenic or autologous BM transplant or other solid organ transplant.
- Has known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, cyclophosphamide, bortezomib, boron or mannitol
- Has active infection or active bleeding.
- Has intolerance or contraindications to antiviral prophylaxis.
- Has known Human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
- Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/milliliter (mL) Cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts >=350 cells/microliter.
- No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.
- Has prior therapy for AL amyloidosis or MM, with the exception of 160 milligram (mg) dexamethasone (or equivalent corticosteroid) maximum exposure prior to enrollment.
- Has received any live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin
- Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of interventional medical research within 28 days before enrollment.
- Has an alanine aminotransferase (ALT) value >2.5*upper limit of normal (ULN) or >3*ULN if hepatic involvement of AL amyloidosis
- Has a total bilirubin value >1.5*ULN
- Has cirrhosis or current unstable liver or biliary disease per investigator assessment Has documented presence of Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of study intervention, unless HBV DNA is undetectable at screening and participant receives antiviral prophylaxis or treatment.
- Has a 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 study intervention unless the following criteria are met:
- RNA test negative.
- Successful antiviral treatment (usually 8 weeks duration), followed by a negative Hepatitis C virus RNA test after a washout period of at least 4 weeks.
- Chronic hepatitis B infection, with the presence of HBsAg and/or detectable hepatitis B virus deoxyribonucleic acid (HBV DNA), and hepatitis D co-infection, with hepatitis D antibody and/or RNA, within 3 months
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 3 countries
United States8 sites, 8 recruiting
- Recruiting
GSK Investigational Site
Aurora, Colorado, 80045
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Boston, Massachusetts, 02118-2307
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hackensack, New Jersey, 07601
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Los Angeles, California, 90048-1804
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nashville, Tennessee, 37232
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New Haven, Connecticut, 06511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rochester, Minnesota, 55905
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Salt Lake City, Utah, 84112
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Adelaide, South Australia, 5000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Box Hill, Victoria, 3128
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fitzroy, Victoria, 3065
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Frankston, Victoria, 3199
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Westmead, New South Wales, 2145
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Woolloongabba, Queensland, 4102
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Liverpool, L7 8YA
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
London, NW1 2BU
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 2, Open-label, Randomized, Dose Optimization Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
- Conditions
- Amyloidosis
- Being tested
- Belantamab mafodotin, Cyclophosphamide, Bortezomib, Dexamethasone
- Keywords
- Amyloid light chain amyloidosis, Bortezomib, Cyclophosphamide, Dexamethasone
- Medical subject headings
- Amyloidosis, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belantamab mafodotinDrug
Belantamab mafodotin will be administered
CyclophosphamideDrug
Cyclophosphamide will be administered
BortezomibDrug
Bortezomib will be administered
DexamethasoneDrug
Dexamethasone will be administered
| Study group | Role | What they receive |
|---|---|---|
| Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD | Experimental | Adult participants with newly diagnosed amyloid light chain (AL) amyloidosis will receive Belantamab mafodotin dose level 1 in combination with CyBorD in dose optimization phase. Receives: Drug: Belantamab mafodotin; Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone |
| Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD | Experimental | Adult participants with newly diagnosed AL amyloidosis will receive Belantamab mafodotin dose level 2 in combination with CyBorD in dose optimization phase. Receives: Drug: Belantamab mafodotin; Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone |
| Dose expansion phase: Belantamab mafodotin + CyBorD | Experimental | Adult participants with newly diagnosed AL amyloidosis will receive belantamab mafodotin at selected dose level from dose optimization phase in combination with CyBorD in dose expansion phase. Receives: Drug: Belantamab mafodotin; Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complete hematologic response (CHR) rate
The overall CHR rate is defined as the proportion of participants who achieve a CHR during or after study treatment initiation, as assessed by the investigator, according to the consensus guidelines for AL amyloidosis.
Measured: Up to approximately 24 months
Secondary outcomes (11)
Number of participants with non-serious adverse events and serious adverse events
Measured: Up to approximately 24 months
Number of participants with clinically significant changes in hematology, and chemistry parameters
Measured: Up to approximately 24 months
Number of participants with ocular findings on ophthalmic examination
Measured: Up to approximately 24 months
Organ response rate (OrRR)
OrRR is defined as the proportions of participants who achieve confirmed organ response (cardiac, renal, or liver) in each organ as per consensus guidelines.
Measured: Up to approximately 5 years
Duration of CHR
Duration of CHR is defined for participants with CHR as the time from the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive disease.
Measured: Up to approximately 5 years
Maximum plasma concentration (Cmax) of belantamab mafodotin
Measured: Up to 24 months
Area under the concentration-time curve (AUC) of belantamab mafodotin
Measured: Up to 24 months
Cmax of Cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF)
Measured: Up to 24 months
AUC of cys-mcMMAF
Measured: Up to 24 months
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Measured: Up to approximately 24 months
Titers of ADAs against belantamab mafodotin
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start24 Jun 2026
- Primary completion12 Jan 2033 (estimated)
- Study completion12 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224672
- Sponsor's protocol ID
- 223963
- Other IDs
- 2025-522803-60, 2025
- Acronym
- ALANIS
- Status last verified
- Nov 2026
- First submitted
- 31 Oct 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Randomized, Dose Optimization Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)
- ClinicalTrials.gov ID
- NCT07224672
- Acronym / sponsor ID
- ALANIS / 223963
- Conditions
- Amyloidosis
- Keywords
- Amyloid light chain amyloidosis, Bortezomib, Cyclophosphamide, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 12 Jan 2033 (estimated)
- Study completion
- 12 Jan 2033 (estimated)
- First posted
- 5 Nov 2025 (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.
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD | Experimental | Drug: Belantamab mafodotin, Drug: Cyclophosphamide, Drug: Bortezomib, Drug: DexamethasoneAdult participants with newly diagnosed amyloid light chain (AL) amyloidosis will receive Belantamab mafodotin dose level 1 in combination with CyBorD in dose optimization phase. |
| Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD | Experimental | Drug: Belantamab mafodotin, Drug: Cyclophosphamide, Drug: Bortezomib, Drug: DexamethasoneAdult participants with newly diagnosed AL amyloidosis will receive Belantamab mafodotin dose level 2 in combination with CyBorD in dose optimization phase. |
| Dose expansion phase: Belantamab mafodotin + CyBorD | Experimental | Drug: Belantamab mafodotin, Drug: Cyclophosphamide, Drug: Bortezomib, Drug: DexamethasoneAdult participants with newly diagnosed AL amyloidosis will receive belantamab mafodotin at selected dose level from dose optimization phase in combination with CyBorD in dose expansion phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant is at least 18 years of age or the legal age of consent
- Has histologically confirmed newly diagnosed primary AL amyloidosis according to the following criteria:
- Measurable clonal disease as defined by at least 1 of the following:
- Not considered candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) as part of first line of therapy
- Is willing to use adequate contraception.
Key exclusion criteria (33 listed)
- Has a previous or current diagnosis of plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome or symptomatic multiple myeloma (MM), as per International Myeloma Working Group criteria for MM including the presence of lytic bone disease , plasmacytomas, or clonal BM plasma cells >=60%.
- Has Immunoglobulin M (IgM)-related AL amyloidosis.
- Has any form of non-AL amyloidosis, including wild type or mutated (Transthyretin amyloidosis [ATTR]) amyloidosis.
- Has evidence of significant cardiovascular (CV) conditions as specified below:
- Has Mayo stage 3B disease
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 mafodotinBelantamab mafodotin will be administered | Drug | Dose expansion phase: Belantamab mafodotin + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD |
| CyclophosphamideCyclophosphamide will be administered | Drug | Dose expansion phase: Belantamab mafodotin + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD |
| BortezomibBortezomib will be administered | Drug | Dose expansion phase: Belantamab mafodotin + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD |
| DexamethasoneDexamethasone will be administered | Drug | Dose expansion phase: Belantamab mafodotin + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD, Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD |
Primary outcome
Overall complete hematologic response (CHR) rate
Time frame: Up to approximately 24 months
The overall CHR rate is defined as the proportion of participants who achieve a CHR during or after study treatment initiation, as assessed by the investigator, according to the consensus guidelines for AL amyloidosis.
11 secondary outcomes
Number of participants with non-serious adverse events and serious adverse events
Time frame: Up to approximately 24 months
Number of participants with clinically significant changes in hematology, and chemistry parameters
Time frame: Up to approximately 24 months
Number of participants with ocular findings on ophthalmic examination
Time frame: Up to approximately 24 months
Organ response rate (OrRR)
Time frame: Up to approximately 5 years
Duration of CHR
Time frame: Up to approximately 5 years
Maximum plasma concentration (Cmax) of belantamab mafodotin
Time frame: Up to 24 months
Area under the concentration-time curve (AUC) of belantamab mafodotin
Time frame: Up to 24 months
Cmax of Cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF)
Time frame: Up to 24 months
AUC of cys-mcMMAF
Time frame: Up to 24 months
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Time frame: Up to approximately 24 months
Titers of ADAs against belantamab mafodotin
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belantamab mafodotin, Cyclophosphamide and Bortezomib in people with Amyloidosis, run by GlaxoSmithKline at 16 sites in 3 countries.
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 12 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Overall complete hematologic response (CHR) rate (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
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 3 Nov 2026.