60 Participants NeededMy employer runs this trial

Belantamab Mafodotin + Other Drugs for Amyloidosis

(ALANIS Trial)

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: GlaxoSmithKline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

I have amyloidosis affecting at least one organ in my body.
I am willing to use effective birth control during the study.
I am at least 18 years old or the legal age of consent.
See 7 more

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

Group I: Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorDExperimental Treatment4 Interventions
Group II: Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorDExperimental Treatment4 Interventions
Group III: Dose expansion phase: Belantamab mafodotin + CyBorDExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
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Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School