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3337 Acceptable Toxicity and Good Hematological and Renal Responses after Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma Patients with Renal Insufficiency at Transplant: A Prospective SFGM-TC Observational Study

Program: Oral and Poster Abstracts
Session: 731. Clinical Autologous Transplantation: Results: Poster III
Hematology Disease Topics & Pathways:
Diseases, Plasma Cell Disorders
Monday, December 7, 2020, 7:00 AM-3:30 PM

Laurent Garderet, MD, PhD1, Hafida Ouldjeriouat2*, Mohamed-Amine Bekadja3*, Elisabeth Daguenet, PhD4*, Laure Vincent5*, Damien roos Weil6*, Marguerite Vignon, MD7*, Mohamad Mohty, MD, PhD8, Julie Abraham, MD9*, Martine Escoffre-Barbe, MD10*, Bruno Lioure, MD11*, Redhouane Ahmed Nacer, MD, PhD12*, Denis Caillot13*, Clara Mariette, MD14*, Lionel Karlin, MD15*, Pierre Morel, MD16*, Lila Gilis, MD17*, Emanuelle Leray18*, Anaise Blouet, MD19*, Nicole Raus, Data Manager20*, Marie Robin, MD, PhD21, jean Jacques Boffa22*, Pierre Ronco23*, Marie Thérèse Rubio, MD, PhD24* and Jérôme Cornillon, MD25*

1Service Hematologie, Sorbonne Université, Hopital Pitié Salpêtière APHP, Paris, France
2hematology department, CHU Oran, Oran, Algeria
3Department of Hematology and Cell Therapy, EHU 1st Novembre 1954 Bir el Djir Usto, University Ahmed Benbella 1, Oran, Algeria
4Institut de Cancérologie Lucien Neuwirth, Saint Priest En Jarez, France
5CHU de Montpellier / Département d'hématologie clinique, Hôpital Saint-Eloi, Montpellier, France
6Hematology department, Sorbonne Université Hôpital Pitié Salpêtrière APHP, Paris, FRA
7Cochin Hospital, Hematology Department, Paris, France
8Saint Antoine Hospital, Paris, France
9Clinical Hematology Service, CHU Limoges, Limoges, FRA
10Hematology department, CHU Rennes, Rennes, France
11Département d'Hématologie et d'Oncologie, CHU Strasbourg, Strasbourg, FRA
12Department of Hematology and bone marrow transplant, CPMC, Algiers, Algeria
13CHU de Dijon, Service d'Hématologie, Dijon, France
14CHU Grenoble, Hematology, Grenoble, France
15Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France
16Department of Hematology, Chu Amiens, Salouel, France
17Centre Leon Berard, Departement d'Oncologie Medicale, Lyon, France
18Hematology department, CH Argenteuil, Argenteuil, France
19Service oncologie-hématologie, Centre Hospitalier, Cholet, Cholet, France
20SFGM-TC, Lyon, France
21Hôpital Saint-Louis, APHP, Paris, France
22Nephrology department, Sorbonne Université Hôpital Tenon APHP, Paris, France
23INSERM Umr_s 1155, Paris, FRA
24CHRU Nancy, Hôpital Brabois, Vandœuvre-les Nancy, France
25Hematology department, Lucien Neuwirth Cancer Institute, Saint-Priest-en-Jarez, France

Background: High dose melphalan (HDM) followed by autologous hematopoietic stem cell transplantation (ASCT) is widely used in multiple myeloma (MM) patients as upfront and salvage therapy. However, the safety and efficacy of ASCT in patients with renal insufficiency (RI) is controversial, which have led to an inconsistent arbitrary cut-off for creatinine clearance (CrCl) for performing ASCT. Here we analyzed prospectively the outcomes of MM patients with severe RI who underwent ASCT.

Methods: We enrolled prospectively 50 newly diagnosed MM patients who had a serum CrCl of <40 mL/min at the time of ASCT and an age of up to 65 years. They all received bortezomib-based induction therapy and had achieved at least a partial response before proceeding to ASCT. The recommended dose of melphalan was 140 mg/m2 and it was advised to infuse at least 3 x106/kg autologous CD34+ cells. Consolidation/maintenance post-ASCT was according to the physician’s choice. The primary endpoint was transplant related mortality.

Results: The patients characteristics at enrollment are given in Table 1. We focused on 44 patients who were beyond 3 months post-ASCT. Light chain MM was frequent (12%), 10% had high risk cytogenetics, 36% increased serum LDH and 10% extramedullary disease. Induction chemotherapies included bortezomib plus IMiDs in 25/44 patients with ≥2 lines of chemotherapy in 12/44. The pre-transplant disease status was sCR in =5%, CR in =15%, VGPR in =39%, and PR in =41% of patients. The number of days of cytapheresis was 2 or less in 95% of cases and the median number of CD34+ cells collected was 3.3 x 106 (1.3-9.5). The median time from diagnosis to ASCT was 175 days (103-307). HDM was 140 mg/m2 in 42/44 patients and 200 mg/m2 in 2/44. All, except two, received consolidation post ASCT (34% missing) and 52% had maintenance therapy (all lenalidomide except two receiving bortezomib) and 7% had no maintenance (41% pending).

Toxicity: We observed one death during the first 100 days post-ASCT, secondary to a septic shock on day 42. The median time to neutrophil engraftment was 12 days (9-68) and to platelet engraftment 13 days (10-70). Among patients receiving RBC transfusions (75%) and platelet transfusions (84%), the median number of RBC transfusions was 3 (1-6) and that of platelet transfusions was 3 (1-10). Response: Nine patients (70%) achieved dialysis independence from the time of diagnosis: 13 patients were on dialysis at diagnosis, 5 at the time of ASCT and 4 three months post-ASCT. Renal function improved post-ASCT in 34% of patients, 14% moving from a CrCl of <40 mL/min to 60 mL/min and 20% to above 60 mL/min. No patient experienced worsened renal function following ASCT. At 100 days post-ASCT, the hematological response had improved in 49% of patients, from PR to VGPR (18%), from PR to CR/sCR (11%) and from VGPR to CR/sCR (20%). The best response obtained was 5% PR, 34% VGPR, 47% CR and 11% sCR with one patient relapsing.

Conclusions: In this preliminary analysis, HDM with ASCT proved to be safe and effective in MM patients with RI at transplant. We observed one death among 44 patients within the first 3 months post-ASCT. A more detailed report of the toxicity will be presented during the meeting along with the survival.

Disclosures: Vincent: takeda: Membership on an entity's Board of Directors or advisory committees, Other: Congress support; Celgene: Membership on an entity's Board of Directors or advisory committees, Other: Congress support; janssen: Membership on an entity's Board of Directors or advisory committees, Other: Congress support. Mohty: Jazz Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau; BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; Stemline: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; GSK: Consultancy, Honoraria, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau. Karlin: Celgene: Other: Personal fees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel support; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel support; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel support, personal fees; Sanofi: Honoraria; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel support, personal fees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel support, personal fees; GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees. Morel: Janssen: Honoraria. Rubio: Medac: Consultancy; Gilead: Honoraria; MSD: Honoraria; Novartis: Honoraria; Neovii: Research Funding.

*signifies non-member of ASH