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  1. Article ; Online: Individualized Approach to Management of Light Chain Amyloidosis.

    Palladini, Giovanni / Milani, Paolo

    Journal of the National Comprehensive Cancer Network : JNCCN

    2023  Volume 21, Issue 1, Page(s) 91–98

    Abstract: Systemic light chain (AL) amyloidosis is caused by a B-cell (most commonly plasma cell) clone that produces a toxic light chain that forms amyloid fibrils in tissues and causes severe, progressive organ dysfunction. The clinical presentation is protean, ... ...

    Abstract Systemic light chain (AL) amyloidosis is caused by a B-cell (most commonly plasma cell) clone that produces a toxic light chain that forms amyloid fibrils in tissues and causes severe, progressive organ dysfunction. The clinical presentation is protean, and patients are usually extremely frail, thus requiring careful adaptation of the treatment approach. However, the severity of organ involvement can be accurately assessed with biomarkers that allow a sharp prognostic stratification and precise tailoring of the treatment strategy. Moreover, the availability of biomarker-based response criteria also allows adjustment of the treatment approach over time. The recent completion of 3 large randomized clinical trials has offered new evidence for designing appropriate treatments. All this information has recently been integrated in the joint guidelines of the International Society of Amyloidosis and the European Hematology Association for the treatment of AL amyloidosis. Other clinical trials are underway testing new agents directed against the amyloid clone and the amyloid deposits. Our understanding of the peculiarities of the amyloid clone, as well as our ability to detect residual clonal disease and improve organ dysfunction, are also being refined and will result in more precise personalization of the treatment approach.
    MeSH term(s) Humans ; Multiple Organ Failure ; Amyloidosis/diagnosis ; Amyloidosis/etiology ; Amyloidosis/therapy ; Immunoglobulin Light-chain Amyloidosis/diagnosis ; Immunoglobulin Light-chain Amyloidosis/etiology ; Immunoglobulin Light-chain Amyloidosis/therapy ; Amyloid/therapeutic use ; Prognosis ; Biomarkers
    Chemical Substances Amyloid ; Biomarkers
    Language English
    Publishing date 2023-01-12
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2250759-0
    ISSN 1540-1413 ; 1540-1405
    ISSN (online) 1540-1413
    ISSN 1540-1405
    DOI 10.6004/jnccn.2022.7092
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Diagnosis and Treatment of AL Amyloidosis.

    Palladini, Giovanni / Milani, Paolo

    Drugs

    2023  Volume 83, Issue 3, Page(s) 203–216

    Abstract: Systemic light chain (AL) amyloidosis is caused by an usually small B cell clone that produces a toxic light chain forming amyloid deposits in tissue. The heart and kidney are the major organs affected, but all others, with the exception of the CNS, can ... ...

    Abstract Systemic light chain (AL) amyloidosis is caused by an usually small B cell clone that produces a toxic light chain forming amyloid deposits in tissue. The heart and kidney are the major organs affected, but all others, with the exception of the CNS, can be involved. The disease is rapidly progressive, and it is still diagnosed late. Screening programs in patients followed by hematologists for plasma cell dyscrasias should be considered. The diagnosis requires demonstration in a tissue biopsy of amyloid deposits formed by immunoglobulin light chains. The workup of patients with AL amyloidosis requires adequate technology and expertise, and patients should be referred to specialized centers whenever possible. Stagings are based on cardiac and renal biomarkers and guides the choice of treatment. The combination of daratumumab, cyclophosphamide, bortezomib and dexamethasone (dara-CyBorD) is the current standard of care. Autologous stem cell transplant is performed in eligible patients, especially those who do not attain a satisfactory response to dara-CyBorD. Passive immunotherapy targeting the amyloid deposits combined with chemo-/immune-therapy targeting the amyloid clone is currently being tested in controlled clinical trials. Response to therapy is assessed based on validated criteria. Profound hematologic response is the early goal of treatment and should be accompanied over time by deepening organ response. Many relapsed/refractory patients are also treated with daratumumab combination, but novel regimens will be needed to rescue daratumumab-exposed subjects. Immunomodulatory drugs are the current cornerstone of rescue therapy, while immunotherapy targeting B-cell maturation antigen and inhibitors of Bcl-2 are promising alternatives.
    MeSH term(s) Humans ; Immunoglobulin Light-chain Amyloidosis/diagnosis ; Immunoglobulin Light-chain Amyloidosis/drug therapy ; Plaque, Amyloid/complications ; Bortezomib ; Kidney ; Cyclophosphamide
    Chemical Substances Bortezomib (69G8BD63PP) ; Cyclophosphamide (8N3DW7272P)
    Language English
    Publishing date 2023-01-18
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 120316-2
    ISSN 1179-1950 ; 0012-6667
    ISSN (online) 1179-1950
    ISSN 0012-6667
    DOI 10.1007/s40265-022-01830-z
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  3. Article ; Online: Two-hit strategy for treating AL amyloidosis?

    Merlini, Giampaolo / Palladini, Giovanni

    Blood

    2022  Volume 138, Issue 25, Page(s) 2596–2598

    MeSH term(s) Amyloidosis/therapy ; Humans ; Immunoglobulin Light Chains ; Immunoglobulin Light-chain Amyloidosis/drug therapy
    Chemical Substances Immunoglobulin Light Chains
    Language English
    Publishing date 2022-01-20
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 80069-7
    ISSN 1528-0020 ; 0006-4971
    ISSN (online) 1528-0020
    ISSN 0006-4971
    DOI 10.1182/blood.2021013817
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  4. Article ; Online: Advances in the treatment of light chain amyloidosis.

    Palladini, Giovanni / Milani, Paolo

    Current opinion in oncology

    2022  Volume 34, Issue 6, Page(s) 748–756

    Abstract: Purpose of review: After many years, the management of systemic light chain (AL) amyloidosis is entering the era of evidence-based medicine, with three recently published randomized clinical trials, a regimen (daratumumab, cyclophosphamide, bortezomib, ... ...

    Abstract Purpose of review: After many years, the management of systemic light chain (AL) amyloidosis is entering the era of evidence-based medicine, with three recently published randomized clinical trials, a regimen (daratumumab, cyclophosphamide, bortezomib, and dexamethasone, daratumumab-CyBorD) labeled for upfront therapy, more clinical trials ongoing, and published guidelines. In this review, we discuss how current practice is changing based on this data.
    Recent findings: Daratumumab-CyBorD grants unprecedentedly high rates of hematologic and organ response and became the novel standard-of-care in AL amyloidosis. The International Society of Amyloidosis and the European Hematology Association issued common guidelines for autologous stem cell transplant (ASCT) in this disease. Improved patient selection and effective induction regimens greatly reduced ASCT-related mortality. Venetoclax is emerging as a very effective option in patients harboring the common t(11;14) abnormality. Rapid and profound reduction of the amyloid free light chain can improve survival also at advanced stages.
    Summary: Daratumumab-CyBorD is being integrated into the treatment flow-chart whereas the role of ASCT is being redefined. New approaches are being tested in clinical trials. Treatment of daratumumab-refractory patients and validation of criteria of hematologic progression to be used in clinical trials and in individual patient management are current areas of research.
    MeSH term(s) Amyloidosis/drug therapy ; Bortezomib/therapeutic use ; Cyclophosphamide ; Dexamethasone ; Humans ; Immunoglobulin Light Chains/therapeutic use ; Treatment Outcome
    Chemical Substances Immunoglobulin Light Chains ; Bortezomib (69G8BD63PP) ; Dexamethasone (7S5I7G3JQL) ; Cyclophosphamide (8N3DW7272P)
    Language English
    Publishing date 2022-08-04
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 1049384-0
    ISSN 1531-703X ; 1040-8746
    ISSN (online) 1531-703X
    ISSN 1040-8746
    DOI 10.1097/CCO.0000000000000881
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    Zs.A 3046: Show issues Location:
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  5. Article ; Online: Role of autologous haematopoietic cell transplantation in the treatment of systemic light chain amyloidosis in the era of anti-CD38 monoclonal antibodies.

    Chakraborty, Rajshekhar / Milani, Paolo / Palladini, Giovanni / Gertz, Morie

    The Lancet. Haematology

    2023  Volume 10, Issue 11, Page(s) e936–e940

    Abstract: The primary goal of the initial treatment in systemic light chain amyloidosis is to obtain a rapid and profound haematological response as safely as possible, coupled with supportive care by a multidisciplinary team. The treatment landscape has evolved ... ...

    Abstract The primary goal of the initial treatment in systemic light chain amyloidosis is to obtain a rapid and profound haematological response as safely as possible, coupled with supportive care by a multidisciplinary team. The treatment landscape has evolved with the introduction of highly effective therapies targeting the plasma cell clones, which can attain high rates of haematological complete response with minimal treatment-related morbidity and mortality. Consequently, the role of high-dose melphalan followed by autologous haematopoietic cell transplantation (HDM-AHCT) is being analysed, particularly considering the absence of randomised controlled trial data supporting its superiority over standard-dose therapies in systemic light chain amyloidosis treatment. In this Viewpoint, we will explore the role of HDM-AHCT in the management of patients with systemic light chain amyloidosis who are eligible for transplantation, and the unresolved questions surrounding HDM-AHCT use as both front-line and salvage therapy.
    MeSH term(s) Humans ; Antineoplastic Agents/therapeutic use ; Immunoglobulin Light-chain Amyloidosis/drug therapy ; Amyloidosis/drug therapy ; Hematopoietic Stem Cell Transplantation ; Antibodies, Monoclonal/therapeutic use ; Transplantation, Autologous ; Treatment Outcome
    Chemical Substances Antineoplastic Agents ; Antibodies, Monoclonal
    Language English
    Publishing date 2023-10-03
    Publishing country England
    Document type Journal Article ; Review
    ISSN 2352-3026
    ISSN (online) 2352-3026
    DOI 10.1016/S2352-3026(23)00175-8
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  6. Article ; Online: Be SMART About AL Amyloidosis.

    Palladini, Giovanni / Merlini, Giampaolo

    Mayo Clinic proceedings

    2021  Volume 96, Issue 6, Page(s) 1390–1392

    MeSH term(s) Amyloidosis/diagnosis ; Consensus ; Humans ; Immunoglobulin Light-chain Amyloidosis/diagnosis ; Multiple Myeloma
    Language English
    Publishing date 2021-06-04
    Publishing country England
    Document type Editorial ; Comment
    ZDB-ID 124027-4
    ISSN 1942-5546 ; 0025-6196
    ISSN (online) 1942-5546
    ISSN 0025-6196
    DOI 10.1016/j.mayocp.2021.04.014
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  7. Article ; Online: The quest for validated treatment endpoints in light chain (AL) amyloidosis: composite criteria for a composite disease.

    Palladini, Giovanni / Milani, Paolo

    Leukemia & lymphoma

    2021  Volume 62, Issue 8, Page(s) 1793–1794

    MeSH term(s) Humans ; Immunoglobulin Light Chains ; Immunoglobulin Light-chain Amyloidosis/diagnosis ; Immunoglobulin Light-chain Amyloidosis/therapy
    Chemical Substances Immunoglobulin Light Chains
    Language English
    Publishing date 2021-04-21
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 1042374-6
    ISSN 1029-2403 ; 1042-8194
    ISSN (online) 1029-2403
    ISSN 1042-8194
    DOI 10.1080/10428194.2021.1913152
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    Zs.A 2997: Show issues Location:
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  8. Article ; Online: The mechanism of action, pharmacological characteristics, and clinical utility of the amyloid depleter birtamimab for the potential treatment of AL amyloidosis.

    Palladini, Giovanni / Liedtke, Michaela / Zago, Wagner / Dolan, Phil / Kinney, Gene G / Gertz, Morie A

    Leukemia & lymphoma

    2024  , Page(s) 1–11

    Abstract: Amyloid light chain (AL) amyloidosis is a progressive plasma cell disorder caused by amyloid deposition resulting in organ damage and failure. Current standard-of-care treatments target clonal plasma cells, the source of misfolded light chains (amyloid ... ...

    Abstract Amyloid light chain (AL) amyloidosis is a progressive plasma cell disorder caused by amyloid deposition resulting in organ damage and failure. Current standard-of-care treatments target clonal plasma cells, the source of misfolded light chains (amyloid precursors), yet only half of patients with advanced disease survive ≥6 months. The amyloid depleter birtamimab is an investigational humanized monoclonal antibody that binds misfolded
    Language English
    Publishing date 2024-04-11
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1042374-6
    ISSN 1029-2403 ; 1042-8194
    ISSN (online) 1029-2403
    ISSN 1042-8194
    DOI 10.1080/10428194.2024.2337803
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  9. Article ; Online: DUAL expectations in light chain amyloidosis.

    Schönland, Stefan / Palladini, Giovanni

    EClinicalMedicine

    2020  Volume 24, Page(s) 100461

    Language English
    Publishing date 2020-07-14
    Publishing country England
    Document type Journal Article
    ISSN 2589-5370
    ISSN (online) 2589-5370
    DOI 10.1016/j.eclinm.2020.100461
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  10. Article ; Online: How I treat AL amyloidosis.

    Palladini, Giovanni / Merlini, Giampaolo

    Blood

    2021  Volume 139, Issue 19, Page(s) 2918–2930

    Abstract: The treatment of patients with systemic light chain (AL) amyloidosis is a challenge to hematologists. Despite its generally small size, the underlying clone causes a rapidly progressing, often devastating multiorgan dysfunction through the toxic light ... ...

    Abstract The treatment of patients with systemic light chain (AL) amyloidosis is a challenge to hematologists. Despite its generally small size, the underlying clone causes a rapidly progressing, often devastating multiorgan dysfunction through the toxic light chains that form amyloid deposits. Clinical manifestations are deceitful and too often recognized at an irreversible stage. However, hematologists are in the unique position to diagnose AL amyloidosis at a presymptomatic stage, checking biomarkers of amyloid organ involvement in patients with monoclonal gammopathies at higher risk to develop the disease. Adequate technology and expertise are needed for a prompt and correct diagnosis, particularly for ruling out non-AL amyloidoses that are now also treatable. Therapy should be carefully tailored based on severity of organ involvement and clonal characteristics, and early and continual monitoring of response is critical. Three recent randomized clinical trials moved AL amyloidosis to evidence-based era. Above all, the daratumumab-bortezomib combination is a new standard-of-care for newly diagnosed patients, inducing rapid and deep responses that translate into high rates of organ response. The availability of new effective drugs allows to better personalize the therapy, reduce toxicity, and improve outcomes. Patients should be treated within clinical trials whenever possible.
    MeSH term(s) Amyloidosis/drug therapy ; Amyloidosis/therapy ; Bortezomib/therapeutic use ; Humans ; Immunoglobulin Light-chain Amyloidosis/drug therapy ; Immunoglobulin Light-chain Amyloidosis/therapy ; Immunotherapy ; Paraproteinemias/drug therapy
    Chemical Substances Bortezomib (69G8BD63PP)
    Language English
    Publishing date 2021-09-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80069-7
    ISSN 1528-0020 ; 0006-4971
    ISSN (online) 1528-0020
    ISSN 0006-4971
    DOI 10.1182/blood.2020008737
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