Belantamab Mafodotin + Other Drugs for Amyloidosis
(ALANIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 .
Are You a Good Fit for This Trial?
This trial is for adults newly diagnosed with AL amyloidosis affecting at least one organ (like the kidneys, heart, liver, gut, or nerves). Participants must have specific lab findings confirming the disease and cannot be candidates for high-dose chemo with stem cell transplant. They need to be able to give consent and agree to use contraception.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Belantamab Mafodotin
- Bortezomib
- Cyclophosphamide
- Dexamethasone
Trial Overview
The study tests a combination of four drugs—belantamab mafodotin, cyclophosphamide, bortezomib, and dexamethasone—in people with newly diagnosed AL amyloidosis. The goal is to see how well this drug combo works and how safe it is.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Adult participants with newly diagnosed AL amyloidosis will receive Belantamab mafodotin dose level 2 in combination with CyBorD in dose optimization phase.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
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