Browsing by Author "Lonial, Sagar"

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    ASTCT Clinical Practice Recommendations for Transplantation and Cellular Therapies in Multiple Myeloma
    (Elsevier, 2022) Dhakal, Binod; Shah, Nina; Kansagra, Ankit; Kumar, Ambuj; Lonial, Sagar; Garfall, Alfred; Cowan, Andrew; Poudyal, Bishesh Sharma; Costello, Caitlin; Gay, Francesca; Cook, Gordon; Quach, Hang; Einsele, Herman; Schriber, Jeff; Hou, Jian; Costa, Luciano; Aljurf, Mahmoud; Chaudhry, Maria; Beksac, Meral; Prince, Miles; Mohty, Mohamad; Janakiram, Murali; Callander, Natalie; Biran, Noa; Malhotra, Pankaj; Rodriguez Otero, Paula; Moreau, Philippe; Abonour, Rafat; Iftikhar, Raheel; Silberman, Rebecca; Mailankody, Sham; Gregory, Tara; Lin, Yi; Carpenter, Paul; Hamadani, Mehdi; Usmani, Saad; Kumar, Shaji; Medicine, School of Medicine
    Over the past decade, therapeutic options in multiple myeloma (MM) have changed dramatically. Given the unprecedented efficacy of novel agents, the role of hematopoietic cell transplantation (HCT) in MM remains under scrutiny. Rapid advances in myeloma immunotherapy including the recent approval of chimeric antigen receptor (CAR) T-cell therapy will impact the MM therapeutic landscape. The American Society for Transplantation and Cellular Therapy convened an expert panel to formulate clinical practice recommendations for role, timing, and sequencing of autologous (auto-HCT), allogeneic (allo-HCT) and CAR T-cell therapy for patients with newly diagnosed (NDMM) and relapsed/refractory MM (RRMM). The RAND-modified Delphi method was used to generate consensus statements. Twenty consensus statements were generated. The panel endorsed continued use of auto-HCT consolidation for patients with NDMM as a standard-of-care option, whereas in the front line allo-HCT and CAR-T were not recommended outside the setting of clinical trial. For patients not undergoing auto-HCT upfront, the panel recommended its use in first relapse. Lenalidomide as a single agent was recommended for maintenance especially for standard risk patients. In the RRMM setting, the panel recommended the use of CAR-T in patients with 4 or more prior lines of therapy. The panel encouraged allo-HCT in RRMM setting only in the context of clinical trial. The panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MM.
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    In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs
    (Elsevier, 2015-08) Tefferi, Ayalew; Kantarjian, Hagop; Rajkumar, S. Vincent; Baker, Lawrence H.; Abkowitz, Jan L.; Adamson, John W.; Advani, Ranjana Hira; Allison, James; Antman, Karen H.; Bast Jr., Robert C.; Bennett, John M.; Benz Jr., Edward J.; Berliner, Nancy; Bertino, Joseph; Bhatia, Ravi; Bhatia, Smita; Bhojwani, Deepa; Blanke, Charles D.; Bloomfield, Clara D.; Bosserman, Linda; Broxmeyer, Hal E.; Byrd, John C.; Cabanillas, Fernando; Canellos, George Peter; Chabner, Bruce A.; Chanan-Khan, Asher; Cheson, Bruce; Clarkson, Bayard; Cohn, Susan L.; Colon-Otero, Gerardo; Cortese, Jorge; Coutre, Steven; Cristofanilli, Massimo; Curran Jr., Walter J.; Daley, George Q.; DeAngelo, Daniel J.; Deeg, H. Joachim; Einhorn, Lawrence H.; Erba, Harry P.; Esteva, Francisco J.; Estey, Elihu; Fidler, Isaiah J.; Foran, James; Forman, Stephen; Freireich, Emil; Fuchs, Charles; George, James N.; Gertz, Morie A.; Giralt, Sergio; Golomb, Harvey; Greenberg, Peter; Gutterman, Jordan; Handin, Robert I.; Hellman, Samuel; Hoff, Paulo Marcelo; Hoffman, Ronald; Hong, Waun Ki; Horowitz, Mary; Hortobagyi, Gabriel N.; Hudis, Clifford; Issa, Jean Pierre; Johnson, Bruce Evan; Kantoff, Philip W.; Kaushansky, Kenneth; Khayat, David; Khuri, Fadlo R.; Kipps, Thomas J.; Kripke, Margaret; Kyle, Robert A.; Larson, Richard A.; Lawrence, Theodore S.; Levine, Ross; Link, Michael P.; Lippman, Scott M.; Lonial, Sagar; Lyman, Gary H.; Markman, Maurie; Mendelsohn, John; Meropol, Neal J.; Messinger, Yoav; Mulvey, Therese M.; O’Brien, Susan; Perez-Soler, Roman; Pollock, Raphael; Prchal, Josef; Press, Oliver; Radich, Jerald; Rai, Kanti; Rosenberg, Saul A.; Rowe, Jacob M.; Rugo, Hope; Runowicz, Carolyn D.; Sandmaier, Brenda M.; Saven, Alan; Schafer, Andrew I.; Schiffer, Charles; Sekeres, Mikkael A.; Silver, Richard T.; Siu, Lillian L.; Steensma, David P.; Stewart, F. Marc; Stock, Wendy; Stone, Richard; Storb, Rainer; Strong, Louise C.; Tallman, Martin S.; Thompson, Michael; Ueno, Naoto T.; Van Etten, Richard A.; Vose, Julie M.; Wiernik, Peter H.; Winer, Eric P.; Younes, Anas; Zelenetz, Andrew D.; Department of Medicine, IU School of Medicine
    Comment in Lowering the High Cost of Cancer Drugs--III. [Mayo Clin Proc. 2016] Lowering the High Cost of Cancer Drugs--I. [Mayo Clin Proc. 2016] Lowering the High Cost of Cancer Drugs--IV. [Mayo Clin Proc. 2016] In Reply--Lowering the High Cost of Cancer Drugs. [Mayo Clin Proc. 2016] US oncologists call for government regulation to curb drug price rises. [BMJ. 2015]
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    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.
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    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.