Browsing by Author "Weisel, Katja"

Now showing 1 - 4 of 4
  • Thumbnail Image
    Item
    Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study
    (Wiley, 2021) Lonial, Sagar; Lee, Hans C.; Badros, Ashraf; Trudel, Suzanne; Nooka, Ajay K.; Chari, Ajai; Abdallah, Al-Ola; Callander, Natalie; Sborov, Douglas; Suvannasankha, Attaya; Weisel, Katja; Voorhees, Peter M.; Womersley, Lynsey; Baron, January; Piontek, Trisha; Lewis, Eric; Opalinska, Joanna; Gupta, Ira; Cohen, Adam D.; Medicine, School of Medicine
    Background: On the basis of the DREAMM-2 study (ClinicalTrials.gov identifier NCT03525678), single-agent belantamab mafodotin (belamaf) was approved for patients with relapsed or refractory multiple myeloma (RRMM) who received ≥4 prior therapies, including anti-CD38 therapy. The authors investigated longer term efficacy and safety outcomes in DREAMM-2 after 13 months of follow-up among patients who received belamaf 2.5 mg/kg. Methods: DREAMM-2 is an ongoing, phase 2, open-label, 2-arm study investigating belamaf (2.5 or 3.4 mg/kg) in patients with RRMM who had disease progression after ≥3 lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors and refractory and/or intolerant to an anti-CD38 therapy. The primary outcome was the proportion of patients that achieved an overall response, assessed by an independent review committee. Results: As of January 31, 2020, 10% of patients still received belamaf 2.5 mg/kg. Thirty-one of 97 patients (32%; 97.5% confidence interval [CI], 21.7%-43.6%) achieved an overall response, and 18 responders achieved a very good partial response or better. Median estimated duration of response, overall survival, and progression-free survival were 11.0 months (95% CI, 4.2 months to not reached), 13.7 months (95% CI, 9.9 months to not reached), and 2.8 months (95% CI, 1.6-3.6 months), respectively. Response and survival outcomes in patients who had high-risk cytogenetics or renal impairment were consistent with outcomes in the overall population. Outcomes were poorer in patients with extramedullary disease. In patients who had a clinical response and prolonged dose delays (>63 days; mainly because of corneal events), 88% maintained or deepened responses during their first prolonged dose delay. Overall, there were no new safety signals during this follow-up. Conclusions: Extended follow-up confirms sustained clinical activity without new safety signals with belamaf in this heavily pretreated patient population with RRMM.
  • Thumbnail Image
    Item
    Perspectives on the Risk-Stratified Treatment of Multiple Myeloma
    (American Association for Cancer Research, 2022) Davies, Faith E.; Pawlyn, Charlotte; Usmani, Saad Z.; San-Miguel, Jesus F.; Einsele, Hermann; Boyle, Eileen M.; Corre, Jill; Auclair, Daniel; Cho, Hearn Jay; Lonial, Sagar; Sonneveld, Pieter; Stewart, A. Keith; Bergsagel, P. Leif; Kaiser, Martin F.; Weisel, Katja; Keats, Jonathan J.; Mikhael, Joseph R.; Morgan, Kathryn E.; Ghobrial, Irene M.; Orlowski, Robert Z.; Landgren, C. Ola; Gay, Francesca; Caers, Joseph; Chng, Wee Joo; Chari, Ajai; Walker, Brian A.; Kumar, Shaji K.; Costa, Luciano J.; Anderson, Kenneth C.; Morgan, Gareth J.; Medicine, School of Medicine
    The multiple myeloma treatment landscape has changed dramatically. This change, paralleled by an increase in scientific knowledge, has resulted in significant improvement in survival. However, heterogeneity remains in clinical outcomes, with a proportion of patients not benefiting from current approaches and continuing to have a poor prognosis. A significant proportion of the variability in outcome can be predicted on the basis of clinical and biochemical parameters and tumor-acquired genetic variants, allowing for risk stratification and a more personalized approach to therapy. This article discusses the principles that can enable the rational and effective development of therapeutic approaches for high-risk multiple myeloma.
  • Thumbnail Image
    Item
    Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US
    (Springer, 2021) Davies, Faith; Rifkin, Robert; Costello, Caitlin; Morgan, Gareth; Usmani, Saad; Abonour, Rafat; Palumbo, Antonio; Romanus, Dorothy; Hajek, Roman; Terpos, Evangelos; Cherepanov, Dasha; Stull, Dawn Marie; Huang, Hui; Leleu, Xavier; Berdeja, Jesus; Lee, Hans C.; Weisel, Katja; Thompson, Michael; Boccadoro, Mario; Zonder, Jeffrey; Cook, Gordon; Puig, Noemi; Vela-Ojeda, Jorge; Farrelly, Eileen; Raju, Aditya; Blazer, Marlo; Chari, Ajai; Medicine, School of Medicine
    Multiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) ≥ 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optum's deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs ≥2 were identified. More patients ≥75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT ≥ 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT ≥ 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.
  • Thumbnail Image
    Item
    Treatment Patterns, Survival, Quality of Life, and Healthcare Resource Use Among Patients With Triple-Class Refractory Multiple Myeloma in US Clinical Practice: Findings From the Connect MM Disease Registry
    (Elsevier, 2023) Lee, Hans C.; Ramasamy, Karthik; Weisel, Katja; Abonour, Rafat; Hardin, James W.; Rifkin, Robert M.; Ailawadhi, Sikander; Terebelo, Howard R.; Durie, Brian G. M.; Tang, Derek; Joshi, Prashant; Liu, Liang; Jou, Ying-Ming; Che, Min; Hernandez, Gabriela; Narang, Mohit; Toomey, Kathleen; Gasparetto, Cristina; Wagner, Lynne I.; Jagannath, Sundar; Medicine, School of Medicine
    Background: Adults with triple-class refractory (TCR) multiple myeloma (MM) have limited treatment options and poor prognosis, but the burden of TCR MM has not been well characterized. This study evaluated treatment patterns, overall survival (OS), health-related quality of life (HRQoL), and healthcare resource use (HCRU) among patients with TCR MM in US clinical practice. Patients and methods: Patients with TCR MM in the Connect MM Registry (NCT01081028; a large, US, multicenter, prospective observational cohort study of patients with newly diagnosed MM) were included. Patient characteristics, treatment patterns, HRQoL, and HCRU were analyzed using descriptive statistics. OS was calculated using Kaplan-Meier methodology for the overall cohort and for patients with/without ≥1 post-TCR line of therapy (LOT). Results: A total of 232 patients with TCR MM were included; 155 (67%) had ≥1 post-TCR LOT (post-TCR-Treated subgroup; median 9.9 months of follow-up). Most common post-TCR treatments were carfilzomib (47%), pomalidomide (40%), and daratumumab (26%); median treatment duration was 3.3 months. Median OS was 9.9 months in the overall population, 10.8 months in post-TCR-Treated patients, and 2.6 months for those with no new post-TCR LOT. HRQoL deteriorated and pain increased over 1 year of follow-up, with clinically meaningfully changes in EQ-5D (mean, -0.06 points) and FACT-G (mean, -9.9 points). 124 (53%) patients had ≥1 all-cause hospitalization and 58 (25%) had ≥1 MM-related hospitalization; median annualized length of stay was 35.3 and 42.9 days, respectively. Conclusion: The burden of TCR MM is substantial, emphasizing the need for more effective treatment options in the TCR setting.