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Daratumumab treatments for patients with AL amyloidosis

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

Phase 2 Interventional Janssen Research & Development, LLC · NCT05250973

This study is testing if a new treatment combining daratumumab with other medications is safe for people with heart problems caused by AL amyloidosis, especially focusing on those who are Black or African American.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsdaratumumab, cyclophosphamide
Locations46 sites (Duarte, California and 45 other locations)
Trial IDNCT05250973 on ClinicalTrials.gov

What this trial studies

This study evaluates the cardiac safety of daratumumab-based therapies combined with Cyclophosphamide, Bortezomib, and Dexamethasone in patients newly diagnosed with systemic AL amyloidosis that has affected the heart. Participants are divided into two arms: one receiving immediate treatment and the other receiving deferred treatment. Additionally, the study aims to assess the pharmacokinetics of subcutaneous daratumumab among racial and ethnic minorities, specifically targeting Black or African American patients with AL amyloidosis.

Who should consider this trial

Good fit: Ideal candidates include individuals with newly diagnosed systemic AL amyloidosis with cardiac involvement, particularly those in Mayo Cardiac Stage II and IIIa.

Not a fit: Patients without cardiac involvement or those with earlier stages of AL amyloidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and reduce cardiac toxicity for patients with AL amyloidosis.

How similar studies have performed: Other studies have explored daratumumab in various contexts, but this specific approach focusing on cardiac safety in AL amyloidosis is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Cohort 1: Cardiac involvement (amyloid light chain \[AL\] amyloidosis Mayo Cardiac Stage II and Stage IIIa) with or without other organ(s) involved; Cohort 2: One or more organs impacted by systemic AL amyloidosis according to consensus guidelines
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
* A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of cyclophosphamide or 100 days after discontinuation of daratumumab, whichever is longer
* Cohort 2 only: self-identified racial and ethnic minorities, including Black or African American
* Measurable disease at screening defined by one of the following:

Difference between iFLC and uninvolved FLC (dFLC) \>= 40mg/L per central laboratory Serum involved free light chain (iFLC) \>= 40 mg/L with an abnormal kappa:lambda ratio Serum M-protein \>= 0.5 g/dL

Exclusion Criteria:

* Prior therapy for systemic AL amyloidosis or multiple myeloma including medications that target cluster of differentiation 38 (CD38), with the exception of 160 milligrams(mg) dexamethasone or equivalent corticosteroid maximum exposure prior to randomization/enrollment
* Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, \>=60% plasma cells in the bone marrow, or hypercalcemia related to myeloma.
* Participant received any of the following therapies:

  1. treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less;
  2. vaccinated with an investigational vaccine (except for COVID-19) live, attenuated or replicating viral vector vaccines less than (\<) 4 weeks prior to randomization/enrollment. Participants who are taking strong Cytochrome P450 3A4(CYP3A4) inducers must discontinue their use at least 5 half-lives prior to the first dose of bortezomib
* Stem cell transplantation -Planned stem cell transplant during the first 9 cycles of protocol therapy are excluded. Stem cell collection during the first 9 cycles of protocol therapy is permitted
* Grade 2 sensory or Grade 1 painful peripheral neuropathy

Where this trial is running

Duarte, California and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Amyloidosis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.