Trial reportBlood2020
Safety, tolerability, and response rates of daratumumab in relapsed AL amyloidosis: results of a phase 2 study.
Trial report in Blood, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02841033 (A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis), which is not on this map. Cited by 68 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis
Who cites it
68 citing papers in PubMed, 1 synthesis or guideline pooled it, 151 citations in OpenAlex.
- Cardiac Toxicity in the Treatment of Light Chain Amyloidosis: Systematic Review of Clinical Studies.Current drug safety · 2024Pooled it
- Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA.Annals of hematology · 2023Trial
- Marked progress in AL amyloidosis survival: a 40-year longitudinal natural history study.Blood cancer journal · 2021Trial
- Multicenter phase 2 study of daratumumab monotherapy in patients with previously treated Waldenström macroglobulinemia.Blood advances · 2020Trial
- Trial
- Daratumumab monotherapy for relapsed AL amyloidosis: a single center retrospective analysis.Blood research · 2026Article
- High prevalence of iron deficiency among daratumumab-treated newly diagnosed multiple myeloma patients.British journal of haematology · 2026Article
- Targeting CD38 Across Autoimmune and Plasma Cell-Driven Immune-Mediated Diseases: Rationale, Clinical Evidence, and Emerging Therapeutic Landscape.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Management of relapsed/refractory AL amyloidosis.Blood advances · 2026Review
- Outcomes of patients with systemic light chain amyloidosis treated with DVD front-line therapy.Cardio-oncology (London, England) · 2026Article
- Clinical characteristics and prognosis of immunoglobulin light chain amyloidosis patients.Frontiers in medicine · 2026Article
- Case Report: Autologous stem cell transplantation in a patient diagnosed with AL amyloidosis in Kazakhstan.Frontiers in oncology · 2026Article
- Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis.Annals of medicine · 2025Article
- A Dose-Tailored Anti-Plasma Cell Regimen Lowers the Mortality of Late-Stage Cardiac Amyloidosis.MedComm · 2025Article
- Development and validation of an early prediction model for cardiac death risk in patients with light chain amyloidosis: a multicenter study.Cardio-oncology (London, England) · 2025Article
- Unveiling cardiovascular and respiratory toxicities with monoclonal antibodies in multiple myeloma: disproportionality analysis from the FDA Adverse Event Reporting System.European journal of clinical pharmacology · 2025Article
- The molecular landscape of AL amyloidosis.British journal of haematology · 2025Review
- Review
- Renal AL Amyloidosis: Updates on Diagnosis, Staging, and Management.Journal of clinical medicine · 2024Review
- Risk factors, treatments and outcomes of patients with light chain amyloidosis who relapse after autologous stem cell transplantation.Bone marrow transplantation · 2024Observational
8 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Daratumumab, a monoclonal CD38 antibody, is approved in the treatment of myeloma, but its efficacy and safety in light-chain (AL) amyloidosis has not been formally studied. This prospective phase 2 trial of daratumumab monotherapy for the treatment of AL amyloidosis was designed to determine the safety, tolerability, and hematologic and clinical response. Daratumumab 16 mg/kg was administered by IV infusion once weekly for weeks 1 to 8, every 2 weeks for weeks 9 to 24, and every 4 weeks thereafter until progression or unacceptable toxicity, for up to 24 months. Twenty-two patients with previously treated AL amyloidosis were enrolled. The majority of the patients had received high-dose melphalan and stem cell transplantation and/or treatment with a proteasome inhibitor. The median time between prior therapy and trial enrollment was 9 months (range, 1-180 months). No grade 3-4 infusion-related reactions occurred. The most common grade ≥3 adverse events included respiratory infections (n = 4; 18%) and atrial fibrillation (n = 4, 18%). Hematologic complete and very-good-partial response occurred in 86% of patients. The median time to first and best hematologic response was 4 weeks and 3 months, respectively. Renal response occurred in 10 of 15 patients (67%) with renal involvement and cardiac response occurred in 7 of 14 patients (50%) with cardiac involvement. In summary, daratumumab is well tolerated in patients with relapsed AL amyloidosis and leads to rapid and deep hematologic responses and organ responses. This trial was registered at www.clinicaltrials.gov as #NCT02841033.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.