Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster I
Hematology Disease Topics & Pathways:
Adult, Clinical Practice (Health Services and Quality), Plasma Cell Disorders, Diseases, Infectious Diseases, Treatment Considerations, Adverse Events, Lymphoid Malignancies, Study Population, Human
Materials and Methods: This study included all triple-class and penta-refractory MM patients treated with teclistamab or elranatamab at ten Greater Paris University Hospitals (AP-HP) from July 2022 to January 2024. Data were sourced from the AP-HP Clinical Data Warehouse. Patients treated in AP-HP HaH were compared with inpatients, using a 180-day landmark post BsAbs initiation. Patients were selected for HaH or inpatient care based on clinical criteria, including health status, stability, and patient preference. The primary endpoints were grade ≥ 3 infections and cytopenias. Secondary endpoints included survival and time to treatment failure.
HaH Settings: HaH patients received the first BsAb cycle in the hospital before transitioning to HaH. Before each home administration, HaH physicians and pharmacists reviewed biological results and clinical data. At-home monitoring included vital signs checks post-administration and clinical and biological assessments at 24 and 48 hours. Referring hematologists were alerted for issues according to an algorithm.
Patient Characteristics: The median follow-up was 13 months (IQR 9-16). The analysis included 176 inpatients (129 teclistamab, 47 elranatamab) and 25 HaH patients (19 teclistamab, 6 elranatamab). The median ages were similar (73 years for HaH, 72 years for inpatients), with more patients over 75 in the HaH group (36% vs. 25.6%). ISS stages I, II, and III were 28.0%, 24.0%, and 48.0% in HaH patients and 35.8%, 25.0%, and 39.2% in inpatients. Poor performance status (WHO 2-4) was reported in 32.0% of HaH patients and 46.6% of inpatients. Among HaH patients, 68% were penta-drug refractory versus 72.7% in inpatients. Bone lesions were present in 70% of HaH patients versus 79.5% of inpatients. High-risk cytogenetics were found in 12% of HaH patients and 24.4% of inpatients.
Adverse Events: Grade ≥ 3 infections occurred in 3 HaH patients (12%, all bacterial) versus 36 inpatients (20.5%; p<0.05; 25 bacterial, 11 viral). Demographic factors, prior MM treatment, and clinical biomarkers did not influence infection occurrence. Amoxicillin prophylaxis was more common in the HaH cohort than in the inpatient cohort (58% vs. 28%; p<0.05). TMP-SMX and antiviral prophylaxis rates were similar between cohorts (p=not significant [NS]). Immunoglobulin supplementation was also comparable (60% in HaH and 55.7% in inpatients). There was no significant difference in grade ≥ 3 cytopenias between the cohorts. Baseline neutropenia (HR 2.84; 95% CI, 1.59-5.09), monoclonal protein level (HR 1.76; 95% CI, 1.13-2.74), and hypoalbuminemia (HR 1.59; 95% CI, 1.01-2.20) were associated with higher cytopenia risk, while age over 75 years was associated with a reduced cytopenia risk (HR 0.35; 95% CI, 0.21-0.57). Overall, there was no significant difference in grade ≥ 3 adverse events between the cohorts.
Efficacy and Prognostic Factors: Overall survival (OS), progression-free survival (PFS), and time to treatment failure (TTF) were similar between HaH and inpatient cohorts (p=NS). Median PFS, OS, and TTF were not reached, with all HaH patients still alive. HaH did not significantly impact PFS (HR 1.76; 95% CI, 0.47-5.89). Performance status 2-4 (HR 2.86; 95% CI, 1.75-4.70) significantly increased progression risk, while age over 75 (HR 0.53; 95% CI, 0.3-0.93) was associated with a lower progression risk. HaH did not significantly affect TTF (HR 1.37; 95% CI, 0.39-4.85), whereas performance status 2-4 (HR 3.87; 95% CI, 2.39-6.27), renal insufficiency (HR 2.20; 95% CI, 1.27-3.83), increased LDH (HR 2.09; 95% CI, 1.25-3.48), monoclonal protein level (HR 2.08; 95% CI, 1.28-3.40), and hypoalbuminemia (HR 2.08; 95% CI, 1.28-3.40) were linked to shorter TTF. The HaH cohort had higher complete response rates (56% vs. 31.2%) and very good partial response rates (28% vs. 11.4%) compared to inpatients, with similar partial response rates (16% vs. 16.5%).
Conclusion: This study demonstrates that BsAb treatment in HaH is a safe and effective alternative for MM patients, associated with a lower risk of grade ≥ 3 infections.
Disclosures: Hermine: MSD Avenir: Research Funding; BMS: Research Funding; Alexion: Research Funding; Inatherys: Consultancy, Current equity holder in publicly-traded company, Patents & Royalties, Research Funding; Roche: Research Funding; AB Science: Consultancy, Current equity holder in publicly-traded company, Patents & Royalties, Research Funding. Frenzel: BioMarin: Consultancy; Pfizer: Consultancy, Research Funding; CSL Behring: Consultancy, Research Funding. Choquet: Kite-Gilead: Honoraria. Garderet: Janssen: Honoraria; BMS: Honoraria; Sanofi: Honoraria. Moreau: Celgene, Janssen, Takeda, Amgen, Pfizer, AbbVie, Sanofi: Honoraria; Celgene, Janssen, Takeda, Amgen, Pfizer, AbbVie, Sanofi: Other: Participation on a Data Safety Monitoring Board or advisory board ; Celgene, Janssen, Takeda, Amgen, Pfizer, AbbVie, Sanofi: Consultancy. Zerbit: Janssen: Consultancy; Abbvie: Consultancy.
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