Trial reportHaematologica2013
Lenalidomide, melphalan and dexamethasone in a population of patients with immunoglobulin light chain amyloidosis with high rates of advanced cardiac involvement.
Trial report in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00890552 (A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis), which is not on this map. Cited by 20 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 Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.
- Cardiac Toxicity in the Treatment of Light Chain Amyloidosis: Systematic Review of Clinical Studies.Current drug safety · 2024Pooled it
- Lenalidomide/melphalan/dexamethasone in newly diagnosed patients with immunoglobulin light chain amyloidosis: results of a prospective phase 2 study with long-term follow up.Haematologica · 2017Trial
- First-in-Human Phase I/II Study of NEOD001 in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Trial
- Trial
- ATTR-CM in Patients With Clinically Significant Plasma Cell Dyscrasias: A Case Series Highlighting Diagnostic Challenges.JACC. Case reports · 2026Article
- Efficacy and safety of intravenous daratumumab-based treatments for AL amyloidosis: a systematic review and meta-analysis.Cancer cell international · 2022Review
- Nomogram Model for Dynamic and Individual Prediction of Cardiac Response and Survival for Light Chain Amyloidosis in 737 Patients With Cardiac Involvement.Frontiers in oncology · 2021Article
- Systemic Amyloidosis: a Contemporary Overview.Clinical reviews in allergy & immunology · 2020Review
- Systemic amyloidosis: moving into the spotlight.Leukemia · 2020Review
- Advances in the Treatment of Cardiac Amyloidosis.Current treatment options in oncology · 2020Review
- New developments in diagnosis, risk assessment and management in systemic amyloidosis.Blood reviews · 2020Review
- AL Amyloidosis for the Cardiologist and Oncologist: Epidemiology, Diagnosis, and Management.JACC. CardioOncology · 2019Review
- Rationale and design of DUAL study: Doxycycline to Upgrade response in light chain (AL) amyloidosis (DUAL): A phase 2 pilot study of a two-pronged approach of prolonged doxycycline with plasma cell-directed therapy in the treatment of AL amyloidosis.Contemporary clinical trials communications · 2017Article
- [The consensus of the diagnosis and treatment of primary light chain amyloidosis in China (2016 version)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2016Article
- Quantitative molecular imaging of cardiac amyloidosis: The journey has begun.Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2016Article
- Lenalidomide Desensitization in Systemic Light-Chain Amyloidosis With Multi-Organ Involvement.Journal of clinical medicine research · 2015Article
- Efficacy of bortezomib, cyclophosphamide and dexamethasone in treatment-naïve patients with high-risk cardiac AL amyloidosis (Mayo Clinic stage III).Haematologica · 2014Article
- Oral melphalan and dexamethasone grants extended survival with minimal toxicity in AL amyloidosis: long-term results of a risk-adapted approach.Haematologica · 2014Article
- Update on treatment of light chain amyloidosis.Haematologica · 2014Review
- Light chain amyloidosis: the heart of the problem.Haematologica · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunoglobulin light chain amyloidosis remains incurable despite recent therapeutic advances, and is particularly difficult to treat in patients with amyloid cardiomyopathy. Based on evidence of activity in multiple myeloma, we designed a pilot study of an oral regimen of lenalidomide in combination with dexamethasone and low-dose melphalan in order to evaluate its safety and efficacy in patients with amyloidosis, including those with advanced cardiac involvement. Twenty-five patients were enrolled. Ninety-two percent of patients had cardiac involvement by amyloidosis, and 36% of patients met the criteria for Mayo Clinic cardiac stage III disease. Patients received up to nine cycles of treatment, consisting of lenalidomide 10 mg/day orally on days 1 - 21 (28-day cycle); melphalan 0.18 mg/kg orally on days 1-4; and dexamethasone 40 mg orally on days 1, 8, 15, and 22. High rates (33%) of cardiac arrhythmias and low rates of treatment completion (12.5%) were observed. Ten patients died during the study, all within the first several months of treatment due to acute cardiac events. The overall hematologic response rate was 58%, however organ responses were seen in only 8% of patients. The overall survival rate at 1 year was 58%. While we confirmed the hematologic response rates observed with similar regimens, front-line treatment with melphalan, lenalidomide and dexamethasone was toxic, ineffective, and did not alter survival outcomes for patients with high-risk cardiac disease. Our data highlight the importance of developing novel treatment approaches for amyloid cardiomyopathy. This trial was registered at www.clinicaltrials.gov (NCT00890552).
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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.