Aquarius
Research type
Research Study
Full title
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis
IRAS ID
310371
Contact name
Zina Vas
Contact email
Sponsor organisation
Janssen Research & Development, LLC
Eudract number
2021-002639-48
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 27 days
Research summary
Amyloid light chain (AL) amyloidosis is a rare disorder caused by a usually small plasma cell clone producing a misfolded light chain called amyloid that deposits in vital tissues such as heart, liver, kidney GI tract and so on. Deposition of amyloid in vital organs results in serious and life-threatening organ dysfunction.
The purpose of this study is to compare safety of different daratumumab plus bortezomib, cyclophosphamide and dexamethasone treatment regimens, in newly diagnosed participants with systemic AL amyloidosis. The study will also research the levels of daratumumab study drug in the blood of participants with diverse backgrounds with newly diagnosed amyloid light-chain (AL) amyloidosis.
The study treatment phase will consist of 28-day cycles lasting for up to 24 months. There are 2 treatment groups in this study. Group 1 will include participants with AL amyloidosis heart disease. Group 2 includes participants with AL amyloidosis that affect the heart as well as other organs and will include participants from diverse backgrounds.
Participants in both groups will receive dexamethasone (a steroid), diphenhydramine (an anti-allergic), acetaminophen (a fever reducer) and montelukast (to prevent breathing difficulties, if needed) to prepare their body for daratumumab. These pre-medications will be given 1 to 3 hours before the daratumumab injection. Daratumumab will be administered via subcutaneous infusion for 5 minutes. Starting at cycle 1, participants will receive daratumumab weekly (for 2 months), then every 2 weeks (for 4 months) and then once a month.
Participants in Group 1 will receive bortezomib, cyclophosphamide and dexamethasone starting at Cycle 1 and those in Group 2 will receive bortezomib, cyclophosphamide and dexamethasone starting at Cycle 4. Both groups will receive bortezomib, cyclophosphamide and dexamethasone for up to 6 cycles.
About 150 participants will take part in this study worldwide, with around 10 patients expected in the UK.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0066
Date of REC Opinion
7 Jun 2022
REC opinion
Further Information Favourable Opinion