A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511967-26-00

Acronym

54767414AMY3001

Enrollment

108

Registered

2024-06-20

Start date

2016-11-21

Completion date

2024-11-13

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis)

Brief summary

The primary endpoint is overall complete hematologic response (CHR) rate.

Interventions

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGCyclophosphamide Tablets 50 mg

DRUGJNJ-54767414

DRUGDexamethason 4 mg JENAPHARM®

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is overall complete hematologic response (CHR) rate.	—

Countries

Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026