A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis

Phase 2

Recruiting

• Conditions: light chain amyloidosis; Primary amyloidosis; 10018849

• Registration Number: NL-OMON51367
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Full list of inclusion criteria is found in the protocol section 5.1

- >=18 years of age
- New diagnosis of systemic AL amyloidosis
- Cohort 1: cardiac involvement (AL amyloidosis Mayo Cardiac Stage II and Stage
IIIa) with or without other organs involved
Cohort 2: one or more organs impacted by systemic AL amyloidosis
- ECOG score 0, 1 or 2
- Female: negative pregnancy test

Cohort 2: racial and ethnic minorities, including Black or African

Exclusion Criteria

Full list of exclusion criteria is found in the protocol section 5.2

- Prior therapy for systemic AL amyloidosis or multiple myeloma
- Previous or current diagnosis of symptomatic multiple myeloma
- Participant received any of the following therapies:
a. treatment with an investigational drug or used an invasive investigational
medical device within 14 days or at least 5 half-lives, whichever is less.
b. vaccinated with an investigational vaccine (except for COVID-19), live
attenuated or replicating viral vector vaccines within 4 weeks prior to
randomization/enrollment.
- Evidence of significant cardiovascular conditions
- Participant has an active malignancy other than the disease being treated
under study

Study & Design

• Study Type: Interventional
• Study Design: Not specified