Abstract: FR-PO259
Daratumumab Monotherapy in Severe Patients with AL Amyloidosis and Biopsy-Proven Renal Involvement
Session Information
- Onconephrology: From AKI to CKD and Everything in Between
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Onconephrology
- 1700 Onconephrology
Authors
- Fenoglio, Roberta, University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases, Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, University of Turin, Turin, Italy
- Sciascia, Savino, University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases, Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, University of Turin, Turin, Italy
- Roccatello, Dario, University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases, Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, University of Turin, Turin, Italy
Background
Daratumumab is an anti-CD38 monoclonal antibody recently approved as a first-line therapy on top of standard therapy for the treatment of multiple myeloma and AL amyloidosis. The following data describe the good results reported by our group and the long-term experience achieved in recent years on the efficacy of daratumumab used in monotherapy.
Methods
We described 17 patients (pts) treated with Daratumumab alone, 24 iv administration at a dose of 16 mg/kg. All of them had an histological confirmation and staging of renal involvement and were ineligible for ASCT. Pts could either be naïve or refractory. When feasible, the patient who underwent the whole cycle of therapy underwent a second kidney biopsy at the end of the treatment.
Results
The mean age at diagnosis was 73 years. 16/17 pts had proteinuria that was associated with renal function impairment in 11. 2 pts were on dialysis at the time of therapy initiation. 9 pts completed the treatment; 13 over 17 underwent at least 12 infusions. At the 12th administrations 84,6% of pts had an overall hematological response. 46,5% of pts achieved a complete hematological response, 38% had a very good partial response, and 15.5% were non responders. 5/13 had already achieved an organ response.; the 2 pts who were in dialysis at the time of therapy initiation, remained on dialysis. 7/9 achieved a renal response.
Proteinuria decreased rom 6,02 to 1,28 g/die (p < 0.005) with stabilization/improvement of sCr. 8/9 pts with cardiac involvement obtained at least amelioration. At the end of follow-up 5 pts have persistent hematological and renal response. 1 pt with initial partial response had a relapse. The last pt is still alive and is currently being treated with a second line of therapy, because no hematologic or organ response was achieved with Daratumumab. 7 pts underwent a second kidney biopsy at the end of the treatment. Histological findings showed stable deposits in 6 over 7 cases, while the last one showed a reduction in the extention and amount of amyloid deposits.
Conclusion
Our data, based on the real life experience of our center, suggest that daratumumab monotherapy may represent an effective therapeutic option, capable not only of inducing a substantial improvement in the renal status in pretreated or naïve pts, but also of limiting progression of amyloid deposition.