HDCN Abstract:  ASN Annual Meeting 2020 -- Digital Meeting  

Fenoglio R, Sciascia S, Roccatello D, et al.

Treatment of AL Amyloidosis with Daratumumab Monotherapy

ASN Annual Meeting 2020 -- Digital Meeting
J Am Soc Nephrol (Oct) 31:10A 2020


Immunoglobulin light chain amyloidosis (AL) is characterized by poor outcome. Daratumumab (D) is a first in class anti CD38 human antibody (IgG1κ) which proved to be effective in combination with bortezomib in MM refractory to conventional bortezomib-based regimens. Its effectiveness and safety in the treatment of AL amyloidosis is under study. This study reports the experience with D monotherapy in a series of severe patients (pts) with AL amyloidosis and multiorgan and biopsy-proven renal involvement.


Five pts, mean age 64 years were treated with D following antibody testing and extended RBC antigen phenotyping. Treatment protocol was as follows: 16 mg/kg D i.v. administered weekly for 8 weeks, then every 2 weeks (8 doses), and then monthly for 1 year.


In pt #1, in dialysis, who was refractory to conventional therapies D administration resulted in normalization of the FLC ratio with disappearance of serum M-component and Bence-Jones (BJ) proteinuria. In pt #2 who had a relapsing disease, D treatment resulted in a rapid decrease of proteinuria and N-terminal propeptide (NT-pro-BNP) levels with disappearance of serum M-component and BJ proteinuria and normalization of the FLC ratio. Pt #3 was treated front-line. He had an impressive decrease of proteinuria and NT-proBNP levels with normalization of FLC ratio and disappearance of serum M-component. In pt #4, who was intolerant to conventional regimens, D therapy resulted in decrease in proteinuria, disappearance of serum M-component and improvement in the FLC ratio, which were paralleled by a reduction of NT-proBNP levels. Pt #5 had a relapsing disease. D achieved a decrease of proteinuria, a decrease of serum M- component with increase of FLC ratio. This was the only patient who experienced an infusion reaction during the first dose. The 4 pt with still preserved renal function also showed renal response with sCr improvement or stabilization and a decrease in proteinuria levels These data were paralleled by the reduction of NT-proBNP values in the 3 pts with cardiac involvement.


Daratumumab monotherapy resulted in the disappearance of M-proteins in every pt with FLC ratio normalization in 4 out of 5 subjects and impressive decrease of proteinuria and pro-BNP values proving to be an effective therapeutic option for pretreated/naïve patients with severe AL with renal involvement.

c Copyright 2020 -2021 American Society of Nephrology. Reproduced with permission.
All ASN abstracts from the 2020 Annual Meeting are available at this link and also are archived in .pdf form at ASN-Online.org

Disclaimer: Abstracts often have errors, both typographical and otherwise. This posting is an electronic translation of submitted abstracts which has not been verified against the original submitted abstract nor with the authors for accuracy. As a result, there may be errors, especially with regard to drug doses, but not limited to these. Abstracts undergo only limited review, and data often are changed as a result of the peer review process, so their reliability is less than manuscripts published in peer-reviewed journals. In using these summaries, you are agreeing that you are aware of these limitations.

The materials are provided on an as-is basis without any warranty of any kind, either express or implied. In addition to errors, the information presented may be incomplete or outdated. The information contained is not intended nor recommended as a substitute for professional medical advice. You are advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each device to be used or drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other health care professional, relying on independent experience and knowledge of the patient, to determine drug, disease, and the best treatment for the patient.

To the fullest extent permitted by law, HDCN, ASN and their affiliates and suppliers disclaim all warranties, express or implied, including, but not limited to, any warranty of merchantability, non- infringement or fitness for a particular purpose.

In no event shall HDCN, ASN, or their affiliates or suppliers be liable for any damages whatsoever (including, but not limited to, direct, indirect, incidental, consequential, punitive or exemplary damages, or any damages for loss of profits, use, data, goodwill or other intangibles) arising from or in any way relating to these terms, the materials, or any information, goods or services obtained from or referred to in the materials, whether based on warranty, contract, tort (including, but not limited to, negligence), or any other legal theory, and whether or not any or all of the limited entities is advised of the possibility of such damages.