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4712 Efficacy of Stem Cell Boost (SCB) for Chimeric Antigen Receptor T Cell (CAR-T)-Related Hematologic Toxicity in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)- a Multi-Center Real World Experience

Program: Oral and Poster Abstracts
Session: 653. Multiple Myeloma: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research, Clinical Research, Supportive Care, Real-world evidence, Treatment Considerations
Monday, December 9, 2024, 6:00 PM-8:00 PM

Cindy Varga, MD1*, Myra Robinson2*, James Davis, MD3*, Hamza Sloan Hashmi, MD4*, Thomas Martin, MD5, Anupama Deepa Kumar, MD6, Douglas W Sborov, MD7, Charlotte B Wagner, PharmD8*, Doris K. Hansen, MD9, Omar Castaneda, MD9, Leyla O. Shune, MD10, Shaun DeJarnette10*, Aimaz Afrough, MD11, Larry D Anderson Jr., MD, PhD12, Binod Dhakal, MBBS13, Kinaya Smith, MD14*, Megan M Herr, PhD15, Shambavi Richard, MD16, Alex Lieberman-Cribbin16*, Daniel W. Sherbenou, MD, PhD17, Peter A. Forsberg, MD18 and Peter M. Voorhees, MD19

1Department of Hematologic Oncology & Blood Disorders, Atrium Health Levine Cancer Institute, Charlotte, NC
2Department of Biostatistics and Data Sciences, Levine Cancer Institute, Charlotte, NC
3Department of Hematology-Oncology, The Medical University of South Carolina (MUSC), Charleston, SC
4Division of Hematology-Oncology, Medical University of South Carolina, Charleston, SC
5Department of Hematology, University of California at San Francisco, San Francisco, CA
6University of California, San Francisco, San Francisco, CA
7Huntsman Cancer Institute, University of Utah, Salt Lake City, UT
8Division of Hematology and Hematologic Malignancies, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT
9Department of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
10University of Kansas Medical Center, Kansas City, KS
11Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Coppell, TX
12Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX
13Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
14Medical College of Wisconsin, Milwaukee, WI
15Roswell Park Comprehensive Cancer Center, Buffalo, NY
16Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY
17Division of Hematology, University of Colorado Anschutz Medical Campus, Aurora, CO
18University of Colorado School of Medicine, Aurora, CO
19Plasma Cell Disorders Section, Department of Hematologic Oncology & Blood Disorders, Levine Cancer Center, Charlotte, NC

Background: Cytopenias are a known complication of CAR-T therapy in patients with RRMM. Although cytopenias can be expected immediately following T cell infusion, there is a subpopulation of patients who experience severe and persistent cytopenias. SCB with cryopreserved CD34+ stem cells may be an alternative to prolonged use of growth factor and transfusion support. Davis et al. (TCT 2023) recently reported on a series of 19 RRMM patients who received SCB following BCMA-directed CAR T therapy. Herein, we will describe the clinical characteristics, hematopoietic reconstitution and outcomes in a larger cohort with CAR-T–related hematological toxicity. Methods: This was a multicenter study consisting of data from the US Multiple Myeloma Immunotherapy Consortium comprising of 12 academic institutes. Patients were included if they received SCB following commercial CAR T between 6/2021 and 3/2024. Due to a paucity of historical itemized cell count data, a hemoglobin (Hgb) of >8g/dL, an absolute neutrophil count (ANC) > 500/mm3 and a platelet count of >50K/L were used to define cell count recovery. Progression-free survival (PFS) and overall survival (OS) were evaluated with Kaplan Meier methods. Selective data elements were only available at some sites. Results: 42 patients were included in this analysis. The median age was 65 (range: 39 to 79), 59.5% were male and 14.2% were African American. A third of patients had ISS stage III disease, 54.8% had extramedullary disease and 35.7% had high risk cytogenetics. The median number of prior lines of therapy was 6 (range, 4-15). 42.9% were penta- and 83.3% were triple-class refractory. Thirty-five patients (81.0%) received bridging therapy (BT), of which18 were administered cytotoxic chemotherapy (DCEP. PACE, or HyperCVAD). Only 7 patients attained a > partial response to BT while the remainder either progressed or achieved stable disease. Immediately prior to CAR T, 33% of patients had high bone marrow plasma cell burden (>50%), 2 patients had ANC <1000/mm3 and 11 patients (25.6%) had thrombocytopenia (platelets <50K). 26 patients received ide-cel with a median dose of 416.9 CAR + T cells (range; 275-496.4) and 16 patients received cilta-cel with a median dose of 0.6 CAR + T cells/kg (range; 0.41-0.75). Forty patients (95.2%) developed cytokine release syndrome (95% grade ½). All but one patient required GCSF support and 23 patients (53.5%) received a thrombopoietin agonist. Details related to the stem cell infusions were available in 35 of 42 patients. The median stem cell dose was 2.9 million CD34+ cells/kg (range: 1.76-23.55) given at a median of 53 days (range 24-871) after CAR T infusion. All patients achieved cell count recovery after a median of 22.5 days (range 9-93) following SCB. By day 90 post CAR T, the median ANC was 2110/mm3 (19-8790), the median Hb was 10.4g/dL (range 6.9-14.3), and the median platelet count was 134K/L (range 12-434). Twenty-one patients (50%) developed an infection (11 viral, 10 bacterial). 82.9% achieved a >VGPR,12.2% achieved a PR, one patient attained minimal response and one patient had disease progression. The median follow-up period was13 months (range 1-27). mPFS by CAR T product was 9.2 months for ide-cel and 11.0 months for cilta-cel. The 12-mo OS for ide-cel was 67.3% (95% CI: 48.7%-86%) and 76.2% (95% CI: 52.5%-99.8%) for cilta-cel. Thirteen patients died: 8 from myeloma, 2 from CAR-T-related complications, 2 from infection and 1 from an unrelated cause. Conclusions: Overall, SCB was safe and feasible in this heavily pretreated population. All patients successfully achieved count recovery with a rapid median time to recovery of less than 1 month. Accounting for the small sample size and enrichment for patients with high risk disease, there did not appear to be a clear impact on effectiveness, but additional data in a larger number of patients will be needed to better understand any beneficial or deleterious impact on efficacy.

Disclosures: Varga: Janssen: Honoraria, Research Funding; Arcellx: Research Funding. Martin: GSK: Honoraria; Roche: Honoraria; Pfizer: Honoraria; Sanofi: Research Funding; BMS: Research Funding; Janssen: Research Funding; AMGEN: Research Funding. Sborov: Pfizer: Consultancy, Research Funding; AstraZeneca: Consultancy; Bristol Myers Squibb: Consultancy; Abbvie: Consultancy; Society of Utah Medical Oncology: Membership on an entity's Board of Directors or advisory committees; Bioline: Consultancy; Genentech, Inc.: Consultancy; Arcellx: Consultancy; Janssen: Consultancy; Legend Biotech: Consultancy; GlaxoSmithKline: Consultancy; Sanofi: Consultancy; University of Utah, Huntsman Cancer Institute: Current Employment; Parexel, Keosys: Other: IRC; Binaytara Foundation: Honoraria. Wagner: Pfizer: Consultancy; Jazz: Research Funding. Hansen: Karyopharm: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Janssen: Consultancy; Pfizer: Consultancy. Castaneda: Janssen: Consultancy; BMS: Consultancy; Legend Biotech: Consultancy. Shune: BMS: Membership on an entity's Board of Directors or advisory committees; Norvatis: Membership on an entity's Board of Directors or advisory committees; Johnson and Johnson: Membership on an entity's Board of Directors or advisory committees. Afrough: Karyopharm Therapeutics: Honoraria, Other; Bristol-Myers Squibb: Honoraria, Other; K36 Therapeutics: Research Funding; Adaptive Biotech: Research Funding; Sanofi: Honoraria, Other; Abbvie: Research Funding. Anderson: Beigene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Prothena: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: DSMB; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Cellectar Biosciences: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Other: Travel Expenses, Research Funding. Dhakal: Medical College of Wisconsin: Current Employment; C4 therapeutics: Research Funding; Carsgen: Research Funding; Janssen: Honoraria, Research Funding, Speakers Bureau; Bristol Myers Squibb: Honoraria, Research Funding; Genentech: Consultancy, Honoraria; Karyopharm: Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; Sanofi: Research Funding; Acrellx: Research Funding. Richard: Heidelberg Pharma: Research Funding; C4 Therapeutics: Research Funding; Gracell Therapeutics: Other: Steering Committee, Research Funding; Genentech: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Steering Committee, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Sherbenou: Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jansen: Membership on an entity's Board of Directors or advisory committees. Forsberg: Johnson and Johnson, BMS: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Colorado Blood Cancer Institute: Current Employment; University of Colorado: Ended employment in the past 24 months; Karyopharm: Research Funding. Voorhees: AstraZeneca: Consultancy; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Research Funding; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Lava Therapeutics: Consultancy; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Regeneron: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Research Funding; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

*signifies non-member of ASH