Trial reportLeukemia2022
A randomized phase 3 study of ixazomib-dexamethasone versus physician's choice in relapsed or refractory AL amyloidosis.
Trial report in Leukemia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01659658 (A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Global epidemiology of amyloid light-chain amyloidosis.Orphanet journal of rare diseases · 2022Pooled it
- Phase 2 trial of ixazomib, cyclophosphamide, and dexamethasone for previously untreated light chain amyloidosis.Blood advances · 2022Trial
- Real World Data and Its Impact on the Management of Plasma Cell Dyscrasias.Current hematologic malignancy reports · 2026Review
- Management of relapsed/refractory AL amyloidosis.Blood advances · 2026Review
- Teclistamab in relapsed/refractory light chain amyloidosis: A retrospective multicenter study by the German Society for Amyloid Diseases.HemaSphere · 2026Article
- Amyloidosis and Carpal Tunnel Syndrome: An Update on Diagnostic and Management Considerations.Journal of hand surgery global online · 2026Review
- Case Report: Autologous stem cell transplantation in a patient diagnosed with AL amyloidosis in Kazakhstan.Frontiers in oncology · 2026Article
- Amyloid Light Chain Proteins in Cardiovascular Disease: Pathogenesis and Emerging Therapies for Cardiac Amyloidosis.Pharmaceutical research · 2025Review
- Article
- Long-term follow-up of patients with AL amyloidosis treated on a phase 1 trial of CAEL-101.Blood advances · 2025Article
- BCMA CAR-T: From Multiple Myeloma to Light-Chain Amyloidosis.Current oncology (Toronto, Ont.) · 2025Review
- Multimodality imaging features of systemic amyloidosis: a case report.BMC cardiovascular disorders · 2025Article
- Belantamab Mafodotin in Relapsed/Refractory AL Amyloidosis: Real-World Multi-Center Experience and Review of the Literature.Acta haematologica · 2025Review
- Safety and efficacy of teclistamab in systemic immunoglobulin light chain amyloidosis.Blood cancer journal · 2023Article
- High-Throughput/High Content Imaging Screen Identifies Novel Small Molecule Inhibitors and Immunoproteasomes as Therapeutic Targets for Chordoma.Pharmaceutics · 2023Article
- Molecular Cardiotoxic Effects of Proteasome Inhibitors Carfilzomib and Ixazomib and Their Combination with Dexamethasone Involve Mitochondrial Dysregulation.Cardiovascular toxicology · 2023Article
- Diagnosis and Treatment of AL Amyloidosis.Drugs · 2023Review
- The management of light chain (AL) amyloidosis in Europe: clinical characteristics, treatment patterns, and efficacy outcomes between 2004 and 2018.Blood cancer journal · 2023Observational
- Cardiovascular toxicity from therapies for light chain amyloidosis.Frontiers in cardiovascular medicine · 2023Review
- AL Amyloidosis for Cardiologists: Awareness, Diagnosis, and Future Prospects:JACC. CardioOncology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
In the first phase 3 study in relapsed/refractory AL amyloidosis (TOURMALINE-AL1 NCT01659658), 168 patients with relapsed/refractory AL amyloidosis after 1-2 prior lines were randomized to ixazomib (4 mg, days 1, 8, 15) plus dexamethasone (20 mg, days 1, 8, 15, 22; n = 85) or physician's choice (dexamethasone ± melphalan, cyclophosphamide, thalidomide, or lenalidomide; n = 83) in 28-day cycles until progression or toxicity. Primary endpoints were hematologic response rate and 2-year vital organ deterioration or mortality rate. Only the first primary endpoint was formally tested at this interim analysis. Best hematologic response rate was 53% with ixazomib-dexamethasone vs 51% with physician's choice (p = 0.76). Complete response rate was 26 vs 18% (p = 0.22). Median time to vital organ deterioration or mortality was 34.8 vs 26.1 months (hazard ratio 0.53; 95% CI, 0.32-0.87; p = 0.01). Median treatment duration was 11.7 vs 5.0 months. Adverse events of clinical importance included diarrhea (34 vs 30%), rash (33 vs 20%), cardiac arrhythmias (26 vs 15%), nausea (24 vs 14%). Despite not meeting the first primary endpoint, all time-to-event data favored ixazomib-dexamethasone. These results are clinically relevant to this relapsed/refractory patient population with no approved treatment options.
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