light chain amyloidosis Primary amyloidosis
Conditions
Interventions
Study treatment will be administered on 28 day cycles (± 5 days) for all
treatment groups.
Cohort 1 Arm A and Cohort 2: Dosing will be initiated with the first dose of SC
daratumumab (1800 mg) on C
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide, bortezomib, and dexamethasone (D VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic AL amyloidosis with cardiac involvement and to identify potential mitigation strategies (monitoring of cardiac health/performance via electrocardiogram (ECG), echocardiography (ECHO), 6 min walk test, biomarkers [TroponinT, HS TroponinT, and N-terminal pro-brain natriuretic peptide [NT proBNP]] to inform clinical mitigation strategies alongside comparison of different treatment schedules) for cardiac toxicity. Cohort 2, to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with SC daratumumab in combination with VCd. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary objectives are to evaluate overall efficacy and to assess the safety profile, including cardiac events. | — |
Countries
Netherlands
Outcome results
None listed