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1. Selinexor-based regimens in patients with multiple myeloma after prior anti-B-cell maturation antigen treatment.

Author

Baljevic, Muhamed, Gasparetto, Cristina, Schiller, Gary, Tuchman, Sascha, Callander, Natalie, Lentzsch, Suzanne, Monge, Jorge, Kotb, Rami, Bahlis, Nizar, White, Darrell, Chen, Christine, Sutherland, Heather, Madan, Sumit, LeBlanc, Richard, Sebag, Michael, Venner, Christopher, Bensinger, William, Biran, Noa, DeCastro, Andrew, Van Domelen, Dane, Zhang, Chris, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Bentur, Ohad, and Lipe, Brea

Subjects
anti‐BCMA, multiple myeloma, selinexor
Abstract

There is a lack of consensus on therapy sequencing in previously treated multiple myeloma, particularly after anti-B-cell maturation antigen (BCMA) therapy. Earlier reports on selinexor (X) regimens demonstrated considerable efficacy in early treatment, and after anti-BCMA-targeted chimeric antigen receptor-T cell therapy. Here, we present data from 11 heavily pretreated patients who predominantly received BCMA-antibody-drug conjugate therapy. We observe that X-containing regimens are potent and achieve durable responses with numerically higher overall response and clinical benefit rates, as well as median progression free survival compared to patients prior anti-BCMA therapies, despite being used later in the treatment course. In an area of evolving unmet need, these data reaffirm the efficacy of X-based regimens following broader anti-BCMA therapy.

Published
2022

3. Once weekly selinexor, carfilzomib and dexamethasone in carfilzomib non-refractory multiple myeloma patients

Author

Gasparetto, Cristina, Schiller, Gary J, Tuchman, Sascha A, Callander, Natalie S, Baljevic, Muhamed, Lentzsch, Suzanne, Rossi, Adriana C, Kotb, Rami, White, Darrell, Bahlis, Nizar J, Chen, Christine I, Sutherland, Heather J, Madan, Sumit, LeBlanc, Richard, Sebag, Michael, Venner, Christopher P, Bensinger, William I, Biran, Noa, Ammu, Sonia, Ben-Shahar, Osnat, DeCastro, Andrew, Van Domelen, Dane, Zhou, Tianjun, Zhang, Chris, Bentur, Ohad S, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, and Lipe, Brea

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Cancer, Hematology, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Drug Administration Schedule, Female, Humans, Hydrazines, Male, Maximum Tolerated Dose, Middle Aged, Multiple Myeloma, Oligopeptides, Survival Analysis, Translocation, Genetic, Treatment Outcome, Triazoles, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundProteasome inhibitors (PIs), including carfilzomib, potentiate the activity of selinexor, a novel, first-in-class, oral selective inhibitor of nuclear export (SINE) compound, in preclinical models of multiple myeloma (MM).MethodsThe safety, efficacy, maximum-tolerated dose (MTD) and recommended phase 2 dose (RP2D) of selinexor (80 or 100 mg) + carfilzomib (56 or 70 mg/m2) + dexamethasone (40 mg) (XKd) once weekly (QW) was evaluated in patients with relapsed refractory MM (RRMM) not refractory to carfilzomib.ResultsThirty-two patients, median prior therapies 4 (range, 1-8), were enrolled. MM was triple-class refractory in 38% of patients and 53% of patients had high-risk cytogenetics del(17p), t(4;14), t(14;16) and/or gain 1q. Common treatment-related adverse events (all/Grade 3) were thrombocytopenia 72%/47% (G3 and G4), nausea 72%/6%, anaemia 53%/19% and fatigue 53%/9%, all expected and manageable with supportive care and dose modifications. MTD and RP2D were identified as selinexor 80 mg, carfilzomib 56 mg/m2, and dexamethasone 40 mg, all QW. The overall response rate was 78% including 14 (44%) ≥ very good partial responses. Median progression-free survival was 15 months.ConclusionsWeekly XKd is highly effective and well-tolerated. These data support further investigation of XKd in patients with MM.

Published
2022

4. Integrated safety profile of selinexor in multiple myeloma: experience from 437 patients enrolled in clinical trials.

Author

Gavriatopoulou, Maria, Chari, Ajai, Chen, Christine, Bahlis, Nizar, Vogl, Dan, Jakubowiak, Andrzej, Dingli, David, Cornell, Robert, Hofmeister, Craig, Siegel, David, Berdeja, Jesus, Reece, Donna, White, Darrell, Lentzsch, Suzanne, Gasparetto, Cristina, Huff, Carol, Jagannath, Sundar, Baz, Rachid, Nooka, Ajay, Richter, Joshua, Abonour, Rafat, Parker, Terri, Yee, Andrew, Moreau, Philippe, Lonial, Sagar, Tuchman, Sascha, Weisel, Katja, Mohty, Mohamad, Choquet, Sylvain, Unger, T, Li, Kai, Chai, Yi, Li, Lingling, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, and Dimopoulos, Meletios

Subjects
Aged, Antineoplastic Agents, Appetite, Clinical Trials as Topic, Diarrhea, Fatigue, Female, Humans, Hydrazines, Hyponatremia, Male, Middle Aged, Multiple Myeloma, Nausea, Thrombocytopenia, Triazoles
Abstract

Selinexor is an oral, small molecule inhibitor of the nuclear export protein exportin 1 with demonstrated activity in hematologic and solid malignancies. Side effects associated with selinexor include nausea, vomiting, fatigue, diarrhea, decreased appetite, weight loss, thrombocytopenia, neutropenia, and hyponatremia. We reviewed 437 patients with multiple myeloma treated with selinexor and assessed the kinetics of adverse events and impact of supportive care measures. Selinexor reduced both platelets and neutrophils over the first cycle of treatment and reached a nadir between 28 and 42 days. Platelet transfusions and thrombopoietin receptor agonists were effective at treating thrombocytopenia, and granulocyte colony stimulating factors were effective at resolving neutropenia. The onset of gastrointestinal side effects (nausea, vomiting, and diarrhea) was most common during the first 1-2 weeks of treatment. Nausea could be mitigated with 5-HT3 antagonists and either neurokinin 1 receptor antagonists, olanzapine, or cannbainoids. Loperamide and bismuth subsalicylate ameliorated diarrhea. The primary constitutional side effects of fatigue and decreased appetite could be managed with methylphenidate, megestrol, cannabinoids or olanzapine, respectively. Hyponatremia was highly responsive to sodium replacement. Selinexor has well-established adverse effects that mainly occur within the first 8 weeks of treatment, are reversible, and respond to supportive care.

Published
2020

5. Final analysis of a phase 1/2b study of ibrutinib combined with carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma.

Author

Chari, Ajai, Cornell, Robert, Gasparetto, Cristina, Karanes, Chatchada, Matous, Jeffrey, Niesvizky, Ruben, Lunning, Matthew, Usmani, Saad, Anderson, Larry, Chhabra, Saurabh, Girnius, Saulius, Shustik, Chaim, Stuart, Robert, Lee, Yihua, Salman, Zeena, Liu, Emily, and Valent, Jason

Subjects
Brutons tyrosine kinase inhibitor, carfilzomib, ibrutinib, multiple myeloma, Adenine, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Recurrence, Local, Oligopeptides, Piperidines, Prognosis, Pyrazoles, Pyrimidines, Salvage Therapy, Survival Rate
Abstract

Patients with multiple myeloma (MM) inevitably relapse on initial treatment regimens, and novel combination therapies are needed. Ibrutinib is a first-in-class, once-daily inhibitor of Brutons tyrosine kinase, an enzyme implicated in growth and survival of MM cells. Preclinical data suggest supra-additivity or synergy between ibrutinib and proteasome inhibitors (PIs) against MM. This phase 1/2b study evaluated the efficacy and safety of ibrutinib plus the PI carfilzomib and dexamethasone in patients with relapsed/refractory MM (RRMM). In this final analysis, we report results in patients who received the recommended phase 2 dose (RP2D; ibrutinib 840 mg and carfilzomib 36 mg/m2 with dexamethasone), which was determined in phase 1. The primary efficacy endpoint was overall response rate (ORR). Fifty-nine patients with RRMM received the RP2D (18 in phase 1 and 41 in phase 2b). These patients had received a median of three prior lines of therapy; 69% were refractory to bortezomib, and 90% were refractory to their last treatment. ORR in the RP2D population was 71% (stringent complete response and complete response: 3% each). Median duration of clinical benefit and median duration of response were both 6.5 months. Median progression-free survival (PFS) was 7.4 months, and median overall survival (OS) was 35.9 months. High-risk patients had comparable ORR and median PFS (67% and 7.7 months, respectively) to non-high-risk patients, whose ORR was 73% and median PFS was 6.9 months, whereas median OS in high-risk patients was 13.9 months and not reached in non-high-risk patients. The most common grade ≥3 hematologic treatment-emergent adverse events (TEAEs) were anemia and thrombocytopenia (17% each); the most common grade ≥3 non-hematologic TEAE was hypertension (19%). In patients with RRMM treated with multiple previous lines of therapy, ibrutinib plus carfilzomib demonstrated anticancer activity within the expected efficacy range. No new safety signals were identified and the combination was well-tolerated.

Published
2020

6. Revised International Staging System Is Predictive and Prognostic for Early Relapse (<24 months) after Autologous Transplantation for Newly Diagnosed Multiple Myeloma

Author

Gopalakrishnan, Sathish, D'Souza, Anita, Scott, Emma, Fraser, Raphael, Davila, Omar, Shah, Nina, Gale, Robert Peter, Kamble, Rammurti, Diaz, Miguel Angel, Lazarus, Hillard M, Savani, Bipin N, Hildebrandt, Gerhard C, Solh, Melhem, Freytes, Cesar O, Lee, Cindy, Kyle, Robert A, Usmani, Saad Z, Ganguly, Siddhartha, Assal, Amer, Berdeja, Jesus, Kanate, Abraham S, Dhakal, Binod, Meehan, Kenneth, Kindwall-Keller, Tamila, Saad, Ayman, Locke, Frederick, Seo, Sachiko, Nishihori, Taiga, Gergis, Usama, Gasparetto, Cristina, Mark, Tomer, Nieto, Yago, Kumar, Shaji, and Hari, Parameswaran

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Hematology, Cancer, Transplantation, Adult, Aged, Female, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Prognosis, Recurrence, Transplantation Conditioning, Transplantation, Autologous, Myeloma stage, Postrelapse survival, Transplant, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

The revised International Staging System (R-ISS) combines ISS with genetic markers and lactate dehydrogenase and can prognosticate newly diagnosed multiple myeloma (MM). Early relapse (

Published
2019

7. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial

Author

Stadtmauer, Edward A, Pasquini, Marcelo C, Blackwell, Beth, Hari, Parameswaran, Bashey, Asad, Devine, Steven, Efebera, Yvonne, Ganguly, Siddharta, Gasparetto, Cristina, Geller, Nancy, Horowitz, Mary M, Koreth, John, Knust, Kristin, Landau, Heather, Brunstein, Claudio, McCarthy, Philip, Nelson, Courtney, Qazilbash, Muzaffar H, Shah, Nina, Vesole, David H, Vij, Ravi, Vogl, Dan T, Giralt, Sergio, Somlo, George, and Krishnan, Amrita

Subjects
Cancer, Clinical Trials and Supportive Activities, Hematology, Clinical Research, Rare Diseases, Transplantation, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Consolidation Chemotherapy, Dexamethasone, Disease Progression, Female, Hematopoietic Stem Cell Transplantation, Humans, Lenalidomide, Maintenance Chemotherapy, Male, Melphalan, Middle Aged, Multiple Myeloma, Myeloablative Agonists, Progression-Free Survival, Prospective Studies, Remission Induction, Reoperation, Time Factors, Transplantation, Autologous, United States, Young Adult, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeSingle-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.Patients and methodsPatients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.ResultsThe study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.ConclusionSecond AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population.

Published
2019

9. Clinical and Neuroimaging Correlates of Post-Transplant Delirium

Author

Smith, Patrick, Thompson, Jillian C., Perea, Elena, Wasserman, Brian, Bohannon, Lauren, Racioppi, Alessandro, Choi, Taewoong, Gasparetto, Cristina, Horwitz, Mitchell E., Long, Gwynn, Lopez, Richard, Rizzieri, David A., Sarantopoulos, Stefanie, Sullivan, Keith M., Chao, Nelson J., and Sung, Anthony D.

Published
2020
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10. Acceptance and Commitment Therapy May Improve Physical Function after Allogeneic Hematopoietic Stem Cell Transplant

Author

Infield, Jordan, primary, Smith, Patrick J, additional, Merwin, Rhonda M, additional, Racioppi, Alessandro, additional, O'Connell, Christine, additional, Taylor, Allison O., additional, Hill, Lauren, additional, Winthrop, Hilary, additional, Alyea, Edwin P, additional, Chao, Nelson J., additional, Choi, Taewoong, additional, Gasparetto, Cristina, additional, Hong, Sanghee, additional, Horwitz, Mitchell, additional, Kang, Yubin, additional, Long, Gwynn D, additional, Lopez, Richard D, additional, Ramalingam, Sendhilnathan, additional, Sarantopoulos, Stefanie, additional, and Sung, Anthony D, additional

Published
2024
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11. A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial

Author

Bashir, Qaiser, Nishihori, Taiga, Pasquini, Marcelo C., Martens, Michael J., Wu, Juan, Alsina, Melissa, Anasetti, Claudio, Brunstein, Claudio, Dawson, Peter, Efebera, Yvonne, Gasparetto, Cristina, Geller, Nancy, Giralt, Sergio, Hall, Aric C., Koreth, John, McCarthy, Philip, Scott, Emma, Stadtmauer, Edward A., Vesole, David H., and Hari, Parameswaran

Published
2023
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12. A Phase I Trial of SYK Inhibition with Fostamatinib in the Prevention and Treatment of Chronic Graft-Versus-Host Disease

Author

Lin, Chenyu, DiCioccio, Rachel A., Haykal, Tarek, McManigle, William C., Li, Zhiguo, Anand, Sarah M., Poe, Jonathan C., Bracken, Sonali J., Jia, Wei, Alyea, Edwin P., III, Cardones, Adela R., Choi, Taewoong, Gasparetto, Cristina, Grunwald, Michael R., Hennig, Therese, Kang, Yubin, Long, Gwynn D., Lopez, Richard, Martin, Melissa, Minor, Kerry K., Quinones, Victor L. Perez, Sung, Anthony D., Wiggins, Kristi, Chao, Nelson J., Horwitz, Mitchell E., Rizzieri, David A., and Sarantopoulos, Stefanie

Published
2023
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15. Geriatric Assessment Reveals Actionable Impairments in Hematopoietic Stem Cell Transplantation Candidates Age 18 to 80 Years

Author

Lew, Meagan V., Ren, Yi, Lowder, Yen P., Siamakpour-Reihani, Sharareh, Ramalingam, Sendhilnathan, Romero, Kristi M., Thompson, Jillian C., Bohannon, Lauren M., McIntyre, Jackie, Tang, Helen, Van Opstal, Jolien, Johnson, Ernaya, Cohen, Harvey Jay, Bartlett, David B., Pastva, Amy M., Morey, Miriam, Hall, Katherine S., Smith, Patrick, Peters, Katherine B., Somers, Tamara J., Kelleher, Sarah, Smith, Sophia K., Wischmeyer, Paul E., Lin, Pao-Hwa, Wood, William A., Thorpe, Glynnis, Minor, Kerry, Wiggins, Kristi, Hennig, Therese, Helms, Tanya, Welch, Renee, Matthews, Brittany, Liu, JoAnn, Burleson, Jill, Aberant, Thomas, Engemann, Ashley K., Henshall, Bethany, Darby, Maurisa, Proch, Christina, Dellascio, Michelle, Pittman, Alyssa, Suminguit, Jacob, Choi, Taewoong, Gasparetto, Cristina, Long, Gwynn D., Lopez, Richard D., Sarantopoulos, Stefanie, Horwitz, Mitchell E., Chao, Nelson J., and Sung, Anthony D.

Published
2022
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16. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab

Author

Mikhael, Joseph, Belhadj-Merzoug, Karim, Hulin, Cyrille, Vincent, Laure, Moreau, Philippe, Gasparetto, Cristina, Pour, Ludek, Spicka, Ivan, Vij, Ravi, Zonder, Jeffrey, Atanackovic, Djordje, Gabrail, Nashat, Martin, Thomas G., Perrot, Aurore, Bensfia, Samira, Weng, Qilong, Brillac, Claire, Semiond, Dorothée, Macé, Sandrine, Corzo, Kathryn P., and Leleu, Xavier

Published
2021
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18. Home-Based Hematopoietic Cell Transplantation in the United States

Author

Sung, Anthony D., Giri, Vinay K., Tang, Helen, Nichols, Krista Rowe, Lew, Meagan V., Bohannon, Lauren, Ren, Yi, Jung, Sin-Ho, Dalton, Tara, Bush, Amy, Van Opstal, Jolien, Artica, Alexandra, Messina, Julia, Shelby, Rebecca, Frith, Jennifer, Lassiter, Martha, Burleson, Jill, Leonard, Kari, Potter, Ashley S., Choi, Taewoong, Gasparetto, Cristina J., Horwitz, Mitchell E., Long, Gwynn D., Lopez, Richard D., Sarantopoulos, Stefanie, and Chao, Nelson J.

Published
2022
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19. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma

Author

Kumar, Shaji, Kaufman, Jonathan L., Gasparetto, Cristina, Mikhael, Joseph, Vij, Ravi, Pegourie, Brigitte, Benboubker, Lofti, Facon, Thierry, Amiot, Martine, Moreau, Philippe, Punnoose, Elizabeth A., Alzate, Stefanie, Dunbar, Martin, Xu, Tu, Agarwal, Suresh K., Enschede, Sari Heitner, Leverson, Joel D., Ross, Jeremy A., Maciag, Paulo C., Verdugo, Maria, and Touzeau, Cyrille

Published
2017
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24. Decreased Mortality in 1-Year Survivors of Umbilical Cord Blood Transplant vs. Matched Related or Matched Unrelated Donor Transplant in Patients with Hematologic Malignancies

Author

Bohannon, Lauren, Tang, Helen, Page, Kristin, Ren, Yi, Jung, Sin-Ho, Artica, Alexandra, Britt, Anne, Islam, Prioty, Siamakpour-Reihani, Sharareh, Giri, Vinay, Lew, Meagan, Kelly, Matthew, Choi, Taewoong, Gasparetto, Cristina, Long, Gwynn, Lopez, Richard, Rizzieri, David, Sarantopoulos, Stefanie, Chao, Nelson, Horwitz, Mitchell, and Sung, Anthony

Published
2021
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25. Chlorhexidine Gluconate Bathing Reduces the Incidence of Bloodstream Infections in Adults Undergoing Inpatient Hematopoietic Cell Transplantation

Author

Giri, Vinay K., Kegerreis, Kristin G., Ren, Yi, Bohannon, Lauren M., Lobaugh-Jin, Erica, Messina, Julia A., Matthews, Anita, Mowery, Yvonne M., Sito, Elizabeth, Lassiter, Martha, Saullo, Jennifer L., Jung, Sin-Ho, Ma, Li, Greenberg, Morris, Andermann, Tessa M., van den Brink, Marcel R.M., Peled, Jonathan U., Gomes, Antonio L.C., Choi, Taewoong, Gasparetto, Cristina J., Horwitz, Mitchell E., Long, Gwynn D., Lopez, Richard D., Rizzieri, David A., Sarantopoulos, Stefanie, Chao, Nelson J., Allen, Deborah H., and Sung, Anthony D.

Published
2021
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26. Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients

Author

Racioppi, Alessandro, Dalton, Tara, Ramalingam, Sendhilnathan, Romero, Kristi, Ren, Yi, Bohannon, Lauren, Arellano, Consuelo, Jonassaint, Jude, Miller, Hilary, Barak, Ian, Fish, Laura J., Choi, Taewoong, Gasparetto, Cristina, Long, Gwynn D., Lopez, Richard D., Rizzieri, David A., Sarantopoulos, Stefanie, Horwitz, Mitchell E., Chao, Nelson J., Shah, Nirmish R., and Sung, Anthony D.

Published
2021
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27. Post-Transplant Outcomes in High-Risk Compared with Non–High-Risk Multiple Myeloma: A CIBMTR Analysis

Author

Scott, Emma C., Hari, Parameswaran, Sharma, Manish, Le-Rademacher, Jennifer, Huang, Jiaxing, Vogl, Dan, Abidi, Muneer, Beitinjaneh, Amer, Fung, Henry, Ganguly, Siddhartha, Hildebrandt, Gerhard, Holmberg, Leona, Kalaycio, Matt, Kumar, Shaji, Kyle, Robert, Lazarus, Hillard, Lee, Cindy, Maziarz, Richard T., Meehan, Kenneth, Mikhael, Joseph, Nishihori, Taiga, Ramanathan, Muthalagu, Usmani, Saad, Tay, Jason, Vesole, David, Wirk, Baldeep, Yared, Jean, Savani, Bipin N., Gasparetto, Cristina, Krishnan, Amrita, Mark, Tomer, Nieto, Yago, and D'Souza, Anita

Published
2016
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28. Multivariable Analyses of Prognostic Factors for Progression-Free Survival (PFS) and Complete Response (CR) with Lenalidomide, Bortezomib, and Dexamethasone (RVd) Alone Versus Rvd Plus Autologous Stem Cell Transplantation (ASCT) and Lenalidomide (R) Maintenance to Progression in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) in the Determination Phase 3 Trial

Author

Hassoun, Hani, primary, Jacobus, Susanna J, additional, Richardson, Paul G., additional, Zonder, Jeffrey, additional, Voorhees, Peter M., additional, Kaufman, Jonathan L., additional, Yee, Andrew J, additional, Scott, Emma C, additional, Torka, Pallawi, additional, Libby, Edward N., additional, Reeves, Brandi, additional, Wang, Michael L., additional, Anderson, Larry D., additional, Milner, Carter, additional, Gasparetto, Cristina, additional, Agha, Mounzer, additional, Khan, Dr. Abdullah, additional, Hurd, David D, additional, Avigan, David E., additional, Costello, Caitlin, additional, Jakubowiak, Andrzej, additional, Lonial, Sagar, additional, Raje, Noopur S, additional, Medvedova, Eva, additional, McCarthy, Dr. Philip L., additional, Orlowski, Robert Z., additional, Nadeem, Omar, additional, Laubach, Jacob, additional, Pasquini, Marcelo, additional, Giralt, Sergio, additional, Masone, Kelly, additional, Samur, Mehmet, additional, Perrot, Aurore, additional, Moreau, Philippe, additional, Avet-Loiseau, Hervé, additional, Weller, Edie, additional, Munshi, Nikhil C., additional, and Anderson, Kenneth C., additional

Published
2023
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31. Impact of COVID-19 on Treatment Patterns and Management of Multiple Myeloma: Insights from the Connect® MM Registry

Author

Richter, Joshua, primary, Ailawadhi, Sikander, additional, Lee, Hans C., additional, Hardin, James W., additional, Terebelo, Howard R., additional, Abonour, Rafat, additional, Wagner, Lynne I., additional, Durie, Brian G.M., additional, Omel, James L., additional, Narang, Mohit, additional, Toomey, Kathleen, additional, Rifkin, Robert M., additional, Gasparetto, Cristina J., additional, Yu, Edward, additional, Anand, Jasmeet, additional, Liu, Liang, additional, Jou, Ying-Ming, additional, and Jagannath, Sundar, additional

Published
2022
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32. Outcomes of Second-Line (2L) Triplet+ Regimens in Patients with Relapsed/Refractory Multiple Myeloma (MM) Following Progression after First-Line (1L) Lenalidomide in the Connect® MM Disease Registry

Author

Lee, Hans C., primary, Abonour, Rafat, additional, Ailawadhi, Sikander, additional, Durie, Brian G.M., additional, Gasparetto, Cristina J., additional, Hardin, James W., additional, Narang, Mohit, additional, Omel, James, additional, Rifkin, Robert M., additional, Terebelo, Howard, additional, Toomey, Kathleen, additional, Wagner, Lynne I., additional, Slaff, Samantha, additional, Danforth, Dailan, additional, Chung, Weiyuan, additional, Anand, Jasmeet, additional, Yu, Edward, additional, Tang, Derek, additional, and Jagannath, Sundar, additional

Published
2022
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33. Multivariable Analyses of Prognostic Factors for Progression-Free Survival (PFS) and Complete Response (CR) with Lenalidomide, Bortezomib, and Dexamethasone (RVd) Alone Versus Rvd Plus Autologous Stem Cell Transplantation (ASCT) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) in the Determination Phase 3 Trial

Author

Hassoun, Hani, primary, Jacobus, Susanna J., additional, Richardson, Paul G., additional, Zonder, Jeffrey A., additional, Voorhees, Peter M., additional, Kaufman, Jonathan L., additional, Yee, Andrew J., additional, Scott, Emma C., additional, Torka, Pallawi, additional, Libby, Edward, additional, Reeves, Brandi, additional, Wang, Michael L., additional, Anderson, Larry D., additional, Milner, Carter, additional, Gasparetto, Cristina J., additional, Agha, Mounzer, additional, Khan, Abdullah, additional, Hurd, David Duane, additional, Avigan, David, additional, Costello, Caitlin, additional, Jakubowiak, Andrzej, additional, Lonial, Sagar, additional, Raje, Noopur, additional, Medvedova, Eva, additional, McCarthy, Philip L., additional, Orlowski, Robert Z., additional, Nadeem, Omar, additional, Laubach, Jacob P., additional, Pasquini, Marcelo C., additional, Giralt, Sergio A., additional, Masone, Kelly, additional, Samur, Mehmet K., additional, Perrot, Aurore, additional, Moreau, Philippe, additional, Avet-Loiseau, Herve, additional, Weller, Edie A., additional, Munshi, Nikhil C., additional, and Anderson, Kenneth C., additional

Published
2022
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34. Elranatamab, a BCMA Targeted T-Cell Engaging Bispecific Antibody, Induces Durable Clinical and Molecular Responses for Patients with Relapsed or Refractory Multiple Myeloma

Author

Raje, Noopur, primary, Bahlis, Nizar Jacques, additional, Costello, Caitlin, additional, Dholaria, Bhagirathbhai, additional, Solh, Melhem, additional, Levy, Moshe Yair, additional, Tomasson, Michael H, additional, Damore, Michael A., additional, Jiang, Sibo, additional, Basu, Cynthia, additional, Skoura, Athanasia, additional, Chan, Edward M, additional, Trudel, Suzanne, additional, Jakubowiak, Andrzej, additional, Chu, Michael P, additional, Gasparetto, Cristina J., additional, Dalovisio, Andrew P., additional, Sebag, Michael, additional, and Lesokhin, Alexander M, additional

Published
2022
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35. Older Patients with Myeloma Derive Similar Benefit from Autologous Transplantation

Author

Sharma, Manish, Zhang, Mei-Jie, Zhong, Xiaobo, Abidi, Muneer H., Akpek, Görgün, Bacher, Ulrike, Callander, Natalie S., Dispenzieri, Angela, Freytes, César O., Fung, Henry C., Gale, Robert Peter, Gasparetto, Cristina, Gibson, John, Holmberg, Leona A., Kindwall-Keller, Tamila L., Klumpp, Thomas R., Krishnan, Amrita Y., Landau, Heather J., Lazarus, Hillard M., Lonial, Sagar, Maiolino, Angelo, Marks, David I., Mehta, Paulette, Mikhael, Joseph R., Nishihori, Taiga, Olsson, Richard, Ramanathan, Muthalagu, Roy, Vivek, Savani, Bipin N., Schouten, Harry C., Scott, Emma, Tay, Jason, To, Luen Bik, Vesole, David H., Vogl, Dan T., and Hari, Parameswaran

Published
2014
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36. Hematopoietic Cell Transplant Comorbidity Index Is Predictive of Survival after Autologous Hematopoietic Cell Transplantation in Multiple Myeloma

Author

Saad, Ayman, Mahindra, Anuj, Zhang, Mei-Jie, Zhong, Xiaobo, Costa, Luciano J., Dispenzieri, Angela, Drobyski, William R., Freytes, Cesar O., Gale, Robert Peter, Gasparetto, Cristina J., Holmberg, Leona A., Kamble, Rammurti T., Krishnan, Amrita Y., Kyle, Robert A., Marks, David, Nishihori, Taiga, Pasquini, Marcelo C., Ramanathan, Muthalagu, Lonial, Sagar, Savani, Bipin N., Saber, Wael, Sharma, Manish, Sorror, Mohamed L., Wirk, Baldeep M., and Hari, Parameswaran N.

Published
2014
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42. Immune Recovery in Adult Patients after Myeloablative Dual Umbilical Cord Blood, Matched Sibling, and Matched Unrelated Donor Hematopoietic Cell Transplantation

Author

Kanda, Junya, Chiou, Lun-Wei, Szabolcs, Paul, Sempowski, Gregory D., Rizzieri, David A., Long, Gwynn D., Sullivan, Keith M., Gasparetto, Cristina, Chute, John P., Morris, Ashley, McPherson, Jacalyn, Hale, Jeffrey, Livingston, John Andrew, Broadwater, Gloria, Niedzwiecki, Donna, Chao, Nelson J., and Horwitz, Mitchell E.

Published
2012
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43. Trajectories of quality of life recovery and symptom burden after autologous hematopoietic cell transplantation in multiple myeloma

Author

D'Souza, Anita, primary, Brazauskas, Ruta, additional, Stadtmauer, Edward A., additional, Pasquini, Marcelo C., additional, Hari, Parameswaran, additional, Bashey, Asad, additional, Callander, Natalie, additional, Devine, Steven, additional, Efebera, Yvonne, additional, Ganguly, Siddhartha, additional, Gasparetto, Cristina, additional, Geller, Nancy, additional, Horowitz, Mary M., additional, Koreth, John, additional, Landau, Heather, additional, Brunstein, Claudio, additional, McCarthy, Philip, additional, Qazilbash, Muzaffar H., additional, Giralt, Sergio, additional, Krishnan, Amrita, additional, and Flynn, Kathryn E., additional

Published
2022
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44. Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) with Omidubicel: Long-Term Follow-up from a Single Center

Author

Lin, Chenyu, primary, Morrison, Laura, additional, Alyea, Edwin P, additional, Choi, Taewoong, additional, Gasparetto, Cristina, additional, Long, Gwynn D, additional, Lopez, Richard D, additional, Rizzieri, David A, additional, Sarantopoulos, Stefanie, additional, Sung, Anthony, additional, Chao, Nelson J., additional, Galamidi-Cohen, Einat, additional, Schwarzbach, Aurelie, additional, and Horwitz, Mitchell E., additional

Published
2022
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46. Umbilical cord blood expansion with nicotinamide provides long-term multilineage engraftment

Author

Horwitz, Mitchell E., Chao, Nelson J., Rizzieri, David A., Long, Gwynn D., Sullivan, Keith M., Gasparetto, Cristina, Chute, John P., Morris, Ashley, McDonald, Carolyn, Waters-Pick, Barbara, Stiff, Patrick, Wease, Steven, Peled, Amnon, Snyder, David, Cohen, Einat Galamidi, Shoham, Hadas, Landau, Efrat, Friend, Etty, Peleg, Iddo, Aschengrau, Dorit, Yackoubov, Dima, Kurtzberg, Joanne, and Peled, Tony

Subjects
Cells -- Transplantation, Medical research, Medicine, Experimental, Fetal blood -- Physiological aspects, Niacinamide -- Properties, Health care industry
Abstract

Background. Delayed hematopoietic recovery is a major drawback of umbilical cord blood (UCB) transplantation. Transplantation of ex vivo-expanded UCB shortens time to hematopoietic recovery, but long-term, robust engraftment by the expanded unit has yet to be demonstrated. We tested the hypothesis that a UCB-derived cell product consisting of stem cells expanded for 21 days in the presence of nicotinamide and a noncultured T cell fraction (NiCord) can accelerate hematopoietic recovery and provide long-term engraftment. Methods. In a phase I trial, 11 adults with hematologic malignancies received myeloablative bone marrow conditioning followed by transplantation with NiCord and a second unmanipulated UCB unit. Safety, hematopoietic recovery, and donor engraftment were assessed and compared with historical controls. Results. No adverse events were attributable to the infusion of NiCord. Complete or partial neutrophil and T cell engraftment derived from NiCord was observed in 8 patients, and NiCord engraftment remained stable in all patients, with a median follow-up of 21 months. Two patients achieved long-term engraftment with the unmanipulated unit. Patients transplanted with NiCord achieved earlier median neutrophil recovery (13 vs. 25 days, P < 0.001) compared with that seen in historical controls. The 1-year overall and progression-free survival rates were 82% and 73%, respectively. Conclusion. UCB-derived hematopoietic stem and progenitor cells expanded in the presence of nicotinamide and transplanted with a T cell-containing fraction contain both short-term and long-term repopulating cells. The results justify further study of NiCord transplantation as a single UCB graft. If long-term safety is confirmed, NiCord has the potential to broaden accessibility and reduce the toxicity of UCB transplantation. Trial Registration. Clinicaltrials.gov NCT01221857. Funding. Gamida Cell Ltd., Introduction Delayed hematopoietic and immunologic recovery, graft failure, and graft versus host disease (GVHD) all contribute to transplant-related mortality in adult recipients of umbilical cord blood (UCB) transplantation (1-5). Cell [...]

Published
2014
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47. Trajectories of quality of life recovery and symptom burden after autologous hematopoietic cell transplantation in multiple myeloma.

Author

D'Souza, Anita, Brazauskas, Ruta, Stadtmauer, Edward A., Pasquini, Marcelo C., Hari, Parameswaran, Bashey, Asad, Callander, Natalie, Devine, Steven, Efebera, Yvonne, Ganguly, Siddhartha, Gasparetto, Cristina, Geller, Nancy, Horowitz, Mary M., Koreth, John, Landau, Heather, Brunstein, Claudio, McCarthy, Philip, Qazilbash, Muzaffar H., Giralt, Sergio, and Krishnan, Amrita

Published
2023
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48. Natural Killer Cell-Enriched Donor Lymphocyte Infusions from A 3-6/6 HLA Matched Family Member following Nonmyeloablative Allogeneic Stem Cell Transplantation

Author

Rizzieri, David A., Storms, Robert, Chen, Dong-Feng, Long, Gwynn, Yang, Yiping, Nikcevich, Daniel A., Gasparetto, Cristina, Horwitz, Mitchell, Chute, John, Sullivan, Keith, Hennig, Therese, Misra, Debashish, Apple, Christine, Baker, Megan, Morris, Ashley, Green, Patrick G., Hasselblad, Vic, and Chao, Nelson J.

Published
2010
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49. “Short Course” Bortezomib plus Melphalan and Prednisone as Induction Prior to Transplant or as Frontline Therapy for Nontransplant Candidates in Patients with Previously Untreated Multiple Myeloma

Author

Gasparetto, Cristina, Gockerman, Jon P., Diehl, Louis F., de Castro, Carlos M., Moore, Joseph O., Long, Gwynn D., Horwitz, Mitchell E., Keogh, George, Chute, John P., Sullivan, Keith M., Neuwirth, Rachel, Davis, Patricia H., Sutton, Linda M., Anderson, Russell D., Chao, Nelson J., and Rizzieri, David

Published
2010
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50. Once weekly selinexor, carfilzomib and dexamethasone in carfilzomib non-refractory multiple myeloma patients

Author

Gasparetto, Cristina, primary, Schiller, Gary J., additional, Tuchman, Sascha A., additional, Callander, Natalie S., additional, Baljevic, Muhamed, additional, Lentzsch, Suzanne, additional, Rossi, Adriana C., additional, Kotb, Rami, additional, White, Darrell, additional, Bahlis, Nizar J., additional, Chen, Christine I., additional, Sutherland, Heather J., additional, Madan, Sumit, additional, LeBlanc, Richard, additional, Sebag, Michael, additional, Venner, Christopher P., additional, Bensinger, William I., additional, Biran, Noa, additional, Ammu, Sonia, additional, Ben-Shahar, Osnat, additional, DeCastro, Andrew, additional, Van Domelen, Dane, additional, Zhou, Tianjun, additional, Zhang, Chris, additional, Bentur, Ohad S., additional, Shah, Jatin, additional, Shacham, Sharon, additional, Kauffman, Michael, additional, and Lipe, Brea, additional

Published
2021
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