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4. 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.

Author

Lonial, Sagar, Lee, Hans, Badros, Ashraf, Trudel, Suzanne, Nooka, Ajay, Chari, Ajai, Abdallah, Al-Ola, Callander, Natalie, Sborov, Douglas, Suvannasankha, Attaya, Weisel, Katja, Voorhees, Peter, Womersley, Lynsey, Baron, January, Piontek, Trisha, Lewis, Eric, Opalinska, Joanna, Gupta, Ira, and Cohen, Adam

Subjects
B-cell maturation antigen, antibody-drug conjugate, clinical activity, monoclonal antibody, multiple myeloma, Antibodies, Monoclonal, Humanized, Follow-Up Studies, Humans, Multiple Myeloma, Progression-Free Survival
Abstract

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.

Published
2021

5. Phase 1b trial of tagraxofusp in combination with azacitidine with or without venetoclax in acute myeloid leukemia

Author

Lane, Andrew A., Garcia, Jacqueline S., Raulston, Evangeline G., Garzon, Jada L., Galinsky, Ilene, Baxter, Emilie W., Leonard, Rebecca, DeAngelo, Daniel J., Luskin, Marlise R., Reilly, Christopher R., Stahl, Maximilian, Stone, Richard M., Vedula, Rahul S., Wadleigh, Martha M., Winer, Eric S., Mughal, Tariq, Brooks, Christopher, Gupta, Ira V., Stevenson, Kristen E., Neuberg, Donna S., Ren, Siyang, Keating, Julia, Konopleva, Marina, Stein, Anthony, and Pemmaraju, Naveen

Published
2024
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7. Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy

Author

Jewell, Roxanne C, Kipps, Thomas J, Dürig, Jan, Griskevicius, Laimonas, Stilgenbauer, Stephan, Smolej, Lukáš, Mayer, Jiří, Hess, Georg, Hernandez-Ilizaliturri, Francisco J, Padmanabhan-Iyer, Swaminathan, Fang, Lei, Goldstein, Nancy, Gorczyca, Michele, Gupta, Ira, Lisby, Steen, Wierda, William G, and Investigators, for the Hx-CD20-407 Study

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Cancer, Clinical Trials and Supportive Activities, Hematology, Clinical Research, 6.1 Pharmaceuticals, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Chromosome Aberrations, Drug Administration Schedule, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Remission Induction, Treatment Outcome, Chemoimmunotherapy, chronic lymphocytic leukemia, ofatumumab, pharmacokinetics, Hx-CD20-407 Study Investigators, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

Relationships between patient characteristics, ofatumumab pharmacokinetics, and treatment outcomes were investigated in this phase 2 trial of ofatumumab plus fludarabine and cyclophosphamide (FC) in untreated chronic lymphocytic leukemia. Patients were randomized 1:1 to receive 500 or 1000 mg ofatumumab (Cycle 1; 300 mg) plus FC every 4 weeks for six cycles. Median Cmax and Ctrough values were similar at Cycle 1 regardless of the ultimate clinical outcome. At later doses, these values were higher for patients with complete response (CR) than for other patients. Higher Cmax and Ctrough values at Cycles 3 and 6 were significantly associated with an increased likelihood of CR, whereas ofatumumab pharmacokinetics were not associated with an objective response (OR) on the basis of univariate analyses. Multivariate analyses indicated that baseline patient/disease factors were predominantly associated with CR (17p status) or OR (bulky lymphadenopathy, gender, and serum thymidine kinase), rather than ofatumumab pharmacokinetics.Trial registrationwww.clinicaltrials.gov (NCT00410163).

Published
2017

8. Safety and efficacy of belantamab mafodotin with pembrolizumab in patients with relapsed or refractory multiple myeloma

Author

Suvannasankha, Attaya, primary, Bahlis, Nizar, additional, Trudel, Suzanne, additional, Weisel, Katja, additional, Koenecke, Christian, additional, Oriol, Albert, additional, Voorhees, Peter M., additional, Alonso, Aranzazu A., additional, Callander, Natalie S., additional, Mateos, María‐Victoria, additional, Reddy, Nishitha, additional, Hakim, Shawn, additional, LaMacchia, John, additional, Patel, Nashita, additional, Williams, Danaé, additional, Jewell, Roxanne. C., additional, Zhou, Xiangdong, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, and Nooka, Ajay K., additional

Published
2024
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9. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study

Author

Lonial, Sagar, Lee, Hans C, Badros, Ashraf, Trudel, Suzanne, Nooka, Ajay K, Chari, Ajai, Abdallah, Al-Ola, Callander, Natalie, Lendvai, Nikoletta, Sborov, Douglas, Suvannasankha, Attaya, Weisel, Katja, Karlin, Lionel, Libby, Edward, Arnulf, Bertrand, Facon, Thierry, Hulin, Cyrille, Kortüm, K Martin, Rodríguez-Otero, Paula, Usmani, Saad Z, Hari, Parameswaran, Baz, Rachid, Quach, Hang, Moreau, Philippe, Voorhees, Peter M, Gupta, Ira, Hoos, Axel, Zhi, Eric, Baron, January, Piontek, Trisha, Lewis, Eric, Jewell, Roxanne C, Dettman, Elisha J, Popat, Rakesh, Esposti, Simona Degli, Opalinska, Joanna, Richardson, Paul, and Cohen, Adam D

Published
2020
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10. Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody–Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study

Author

Farooq, Asim V., Degli Esposti, Simona, Popat, Rakesh, Thulasi, Praneetha, Lonial, Sagar, Nooka, Ajay K., Jakubowiak, Andrzej, Sborov, Douglas, Zaugg, Brian E., Badros, Ashraf Z., Jeng, Bennie H., Callander, Natalie S., Opalinska, Joanna, Baron, January, Piontek, Trisha, Byrne, Julie, Gupta, Ira, and Colby, Kathryn

Published
2020
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11. Molecular remission and response patterns in patients with mutant-IDH2 acute myeloid leukemia treated with enasidenib

Author

Stein, Eytan M., DiNardo, Courtney D., Fathi, Amir T., Pollyea, Daniel A., Stone, Richard M., Altman, Jessica K., Roboz, Gail J., Patel, Manish R., Collins, Robert, Flinn, Ian W., Sekeres, Mikkael A., Stein, Anthony S., Kantarjian, Hagop M., Levine, Ross L., Vyas, Paresh, MacBeth, Kyle J., Tosolini, Alessandra, VanOostendorp, Jason, Xu, Qiang, Gupta, Ira, Lila, Thomas, Risueno, Alberto, Yen, Katharine E., Wu, Bin, Attar, Eyal C., Tallman, Martin S., and de Botton, Stéphane

Published
2019
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12. Phase 1b trial of tagraxofusp in combination with azacitidine with or without venetoclax in acute myeloid leukemia

Author

Lane, Andrew A., primary, Garcia, Jacqueline S, additional, Raulston, Evangeline G., additional, Garzon, Jada Lauren N., additional, Galinsky, Ilene, additional, Baxter, Emilie W., additional, Leonard, Rebecca, additional, DeAngelo, Daniel J, additional, Luskin, Marlise R, additional, Reilly, Christopher R., additional, Stahl, Maximilian, additional, Stone, Richard M, additional, Vedula, Rahul S., additional, Wadleigh, Martha, additional, Winer, Eric S, additional, Mughal, Tariq I, additional, Brooks, Christopher, additional, Gupta, Ira V., additional, Stevenson, Kristen E., additional, Neuberg, Donna S., additional, Ren, Siyang, additional, Keating, Julia H., additional, Konopleva, Marina Y., additional, Stein, Anthony S., additional, and Pemmaraju, Naveen, additional

Published
2023
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13. Correction to: Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody–Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study

Author

Farooq, Asim V., Degli Esposti, Simona, Popat, Rakesh, Thulasi, Praneetha, Lonial, Sagar, Nooka, Ajay K., Jakubowiak, Andrzej, Sborov, Douglas, Zaugg, Brian E., Badros, Ashraf Z., Jeng, Bennie H., Callander, Natalie S., Opalinska, Joanna, Baron, January, Piontek, Trisha, Byrne, Julie, Gupta, Ira, and Colby, Kathryn

Published
2020
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15. Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM)

Author

Lonial, Sagar, Nooka, Ajay K., Thulasi, Praneetha, Badros, Ashraf Z., Jeng, Bennie H., Callander, Natalie S., Potter, Heather A., Sborov, Douglas, Zaugg, Brian E., Popat, Rakesh, Degli Esposti, Simona, Byrne, Julie, Opalinska, Joanna, Baron, January, Piontek, Trisha, Gupta, Ira, Dana, Reza, Farooq, Asim V., Colby, Kathryn, and Jakubowiak, Andrzej

Published
2021
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21. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial

Author

Hillmen, Peter, Robak, Tadeusz, Janssens, Ann, Babu, K Govind, Kloczko, Janusz, Grosicki, Sebastian, Doubek, Michael, Panagiotidis, Panagiotis, Kimby, Eva, Schuh, Anna, Pettitt, Andrew R, Boyd, Thomas, Montillo, Marco, Gupta, Ira V, Wright, Oliver, Dixon, Iestyn, Carey, Jodi L, Chang, Chai-Ni, Lisby, Steen, McKeown, Astrid, and Offner, Fritz

Published
2015
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23. Single-Agent Belantamab Mafodotin in Patients with Relapsed or Refractory Multiple Myeloma: Final Analysis of the DREAMM-2 Trial

Author

Nooka, Ajay K., primary, Cohen, Adam, additional, Lee, Hans C., additional, Badros, Ashraf Z., additional, Suvannasankha, Attaya, additional, Callander, Natalie, additional, Abdallah, Al-Ola, additional, Trudel, Suzanne, additional, Chari, Ajai, additional, Libby, Edward, additional, Chaudhry, Maria, additional, Hultcrantz, Malin, additional, Kortuem, Martin, additional, Richardson, Paul G., additional, Popat, Rakesh, additional, Sborov, Douglas W., additional, Hakim, Shawn, additional, Lewis, Eric, additional, Bhushan, Bharat, additional, Gorsh, Boris, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, and Lonial, Sagar, additional

Published
2022
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24. Poster: MM-459 Safety and Clinical Activity of Belantamab Mafodotin With Lenalidomide Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-6 Arm-A Interim Analysis

Author

Quach, Hang, primary, Gironella, Mercedes, additional, Lee, Cindy, additional, Popat, Rakesh, additional, Cannell, Paul, additional, Kasinathan, Ravi S., additional, Chopra, Bikramjit, additional, Rogers, Rachel, additional, Ferron-Brady, Geraldine, additional, Shafi-Harji, Seema, additional, Patel, Nashita, additional, Opalinska, Joanna, additional, Gupta, Ira, additional, and Augustson, Bradley, additional

Published
2022
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25. Oral Abstract: MM-459 Safety and Clinical Activity of Belantamab Mafodotin with Lenalidomide Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-6 Arm-A Interim Analysis

Author

Quach, Hang, primary, Gironella, Mercedes, additional, Lee, Cindy, additional, Popat, Rakesh, additional, Cannell, Paul, additional, Kasinathan, Ravi S., additional, Chopra, Bikramjit, additional, Rogers, Rachel, additional, Ferron-Brady, Geraldine, additional, Shafi-Harji, Seema, additional, Patel, Nashita, additional, Opalinska, Joanna, additional, Gupta, Ira, additional, and Augustson, Bradley, additional

Published
2022
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26. Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study

Author

Czuczman, Myron S., Fayad, Luis, Delwail, Vincent, Cartron, Guillaume, Jacobsen, Eric, Kuliczkowski, Kazimierz, Link, Brian K., Pinter-Brown, Lauren, Radford, John, Hellmann, Andrzej, Gallop-Evans, Eve, DiRienzo, Christine G., Goldstein, Nancy, Gupta, Ira, Jewell, Roxanne C., Lin, Thomas S., Lisby, Steen, Schultz, Martin, Russell, Charlotte A., and Hagenbeek, Anton

Published
2012
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29. Synergistic effects of low-dose belantamab mafodotin in combination with a gamma-secretase inhibitor (nirogacestat) in patients with relapsed/refractory multiple myeloma (RRMM): DREAMM-5 study.

Author

Lonial, Sagar, primary, Grosicki, Sebastian, additional, Hus, Marek, additional, Song, Kevin W., additional, Facon, Thierry, additional, Callander, Natalie Scott, additional, Ribrag, Vincent, additional, Uttervall, Katarina, additional, Quach, Hang, additional, Vorobyev, Vladimir I., additional, Min, Chang Ki, additional, Cheng, Shinta, additional, Smith, L. Mary, additional, Yu, Jing, additional, Collingwood, Therese, additional, Holkova, Beata, additional, Kremer, Brandon, additional, Gupta, Ira, additional, Richardson, Paul G., additional, and Minnema, Monique C., additional

Published
2022
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30. Safety and clinical activity of belantamab mafodotin with lenalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM): DREAMM-6 arm-A interim analysis.

Author

Quach, Hang, primary, Gironella, Mercedes, additional, Lee, Cindy, additional, Popat, Rakesh, additional, Cannell, Paul, additional, Kasinathan, Ravi, additional, Chopra, Bikramjit, additional, Rogers, Rachel, additional, Ferron-Brady, Geraldine, additional, Shafi-Harji, Seema, additional, Patel, Nashita, additional, Opalinska, Joanna, additional, Gupta, Ira V., additional, and Augustson, Bradley, additional

Published
2022
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31. Safety and clinical activity of belantamab mafodotin with pembrolizumab in patients with relapsed/refractory multiple myeloma (RRMM): DREAMM-4 Study.

Author

Suvannasankha, Attaya, primary, Bahlis, Nizar J., additional, Trudel, Suzanne, additional, Weisel, Katja, additional, Koenecke, Christian, additional, Oriol Rocafiguera, Albert, additional, Voorhees, Peter M., additional, Alonso, Aránzazu Alonso, additional, Callander, Natalie Scott, additional, Mateos, Maria-Victoria, additional, Reddy, Nishitha, additional, Hakim, Shawn, additional, Patel, Nashita, additional, Williams, Danae, additional, Jewell, Roxanne C., additional, Zhou, Xiangdong, additional, Gupta, Ira V., additional, and Nooka, Ajay K., additional

Published
2022
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33. The location of cemento enamel junction for CAL measurement: A clinical crisis

Author

Vandana K and Gupta Ira

Subjects
Clinical attachment level, cemento-enamel junction, close measurements, open measurements, stent, Dentistry, RK1-715
Abstract

Background: We face various problems while measuring the Clinical attachment level (CAL) from Cemento-enamel junction (CEJ). This study aims to record and compare the CEJ location measurements using a xed reference point (FRP) [Custom made stent] before and after ap elevation. Materials and Methods: A custom made stent and UNC-15 probe were used. Recording of CEJ location was made using a UNC-15 (Hu-Friedy) probe, before (close CEJ) and after (Open CEJ) the reflection of the flap from the lower edge of the stent in those subjects who were indicated for flap surgery, at baseline. Results: We used statistical analysis involving intra-group comparison done by Paired-′t′ test. The close and the open CEJ measurements demonstrated a, statistically, non-significant difference. The equi-measurements of close and open CEJ numerical data were remarkably lower than the under and overestimation of measurements. Thus, despite certain disadvantages of stent, the FRP provides a simple solution for CAL measurement. Conclusion: The results of this study confirms the objective of the study and strongly suggests that CAL measurements done without FRP is subjected to great variation and the diagnostic and prognostic interpretation of CAL should be viewed seriously in periodontics.

Published
2009

34. Alterations of the marginal soft tissue (gingival margin) following periodontal therapy: A clinical study

Author

Gupta Ira and Vandana K

Subjects
Crown lengthening, curettage, flap surgery, gingival margin position, scaling and root planing, Dentistry, RK1-715
Abstract

Background and Objectives: The evaluation of gingival margin position (GMP) plays a vital role in periodontal therapy and is critical in esthetic/plastic surgical procedures revolving around restorative dentistry. Comparative evaluations of GMP measurements in various periodontal therapies are scarce. Thus, the objectives of this study are to measure the alteration in the gingival margin position following various therapies, and to compare GMP alterations among different treatment modalities from the baseline to six months after therapy. Materials and Methods: The changes in GMP were studied for MB, B, DB, ML, and L sites for SRP, curettage, and flap surgery, and for MB, B, and DB sites for crown lengthening cases at the end of one, three, and six months after therapy. The results were interpreted from baseline to one, three, and six months posttreatment. Statistical Analysis : The results were subjected to statistical analysis. Paired ′t′-test was used for intra-group comparisons and intergroup comparisons were done by one-way ANOVA. Results: The GMP changed from baseline in all the sites at different time periods following various therapies. The net results after six months were an apical shift of GMP in SRP, curettage, and flap surgery, and a coronal shift of GMP in crown lengthening. Conclusion: GMP shows various patterns of alteration after various periodontal therapies. One should wait for the GMP to become stable before attempting any restorative procedure.

Published
2009

35. Ofatumumab retreatment and maintenance in fludarabine-refractory chronic lymphocytic leukaemia patients

Author

Österborg, Anders, Wierda, William G., Mayer, Jiří, Hess, Georg, Hillmen, Peter, Schetelig, Johannes, Schuh, Anna, Smolej, Lukáš, Beck, Christian, Dreyfus, Brigitte, Hellman, Andrzej, Kozlowski, Piotr, Pfreundschuh, Michael, Rizzi, Rita, Spacek, Martin, Phillips, Jennifer L., Gupta, Ira V., Williams, Vanessa, Jewell, Roxanne C., Nebot, Noelia, Lisby, Steen, and Dyer, Martin J. S.

Published
2015
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36. Intergenerational Transmission of Functional Connectivity Profiles in Isolated Reading and Math Networks: A Scoping Review and Study Proposal

Author

Peiris, Ashini, Gupta, Ira, Peters, Lien, and Wilkey, Eric D.

Subjects
intergenerational transmission, Developmental Neuroscience, reading, math, resting-state functional connectivity, Cognitive Neuroscience, education, Cognitive Psychology, Math cognition, math-network, reading-network
Abstract

The scoping review surveyed the existing literature on the topic of resting-state functional connectivity (rsFC) and mathematical cognition. The review revealed that rsFC is indicative of distinct long-term developmental trends in mathematical processing, alluding to individual differences in math abilities. Though there have been multiple studies that investigate individual differences in functional connectivity patterns related to math development and math learning disorders, no study has directly investigated to what degree these neurobiological factors are heritable. To address this topic, the following intergenerational transmission (IT) study is proposed. IT is the transfer of personal values, abilities, behaviours, and traits, from parents to children (Durlauf & Blume, 2016). A recent study conducted by Takagi et al. (2021) investigated the effects of IT via neurobiological substrates. The investigation was primarily concerned with whether identification of a parent-child dyad was possible based on brain similarity, using both structural and functional information. Using a similar method as Takagi et al., we plan to use data from the Parents and Children: Measuring Academic skills using Neuroimaging (PACMAN) project to investigate whether parent-child dyads are identifiable based on brain similarity - specifically using the reading- and math-related networks. Similar to the Takagi et al. (2021) study, we predict that parent-child dyads will be identifiable based on functional connectivity profiles localized in reading- and math-related brain networks.

Published
2021

37. Task-Based and Resting-State Functional Connectivity in Children with Dyscalculia

Author

Gupta, Ira

Subjects
Developmental Neuroscience, preregistration, resting-state functional connectivity, Cognitive Neuroscience, scoping review, mathematical cognition, dyscalculia
Abstract

Resting-state functional connectivity (RSFC) is a unique method in neuroimaging that measures the spontaneous neural activity as the brain is at rest, not actively undergoing any task. It is important in investigating brain patterns that result from brain regions working together throughout an individual’s development. The application of this technique has been limited in the mathematical cognition field, and thus, should be explored further. This preregistration poster focuses on the depth of the literature and studies available in regards to RSFC and math cognition through a scoping review, and then proposes a study in which task-based and resting-state functional connectivity is explored in children with dyscalculia.

Published
2021

38. DREAMM-9: Phase I Study of Belantamab Mafodotin Plus Standard of Care in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma

Author

Usmani, Saad Z., primary, Alonso Alonso, Aránzazu, additional, Quach, Hang, additional, Koh, Youngil, additional, Guenther, Andreas, additional, Min, Chang-Ki, additional, Zhou, Xiaoou L., additional, Kaisermann, Morrys, additional, Mis, Lukasz M., additional, Williams, Danaè, additional, Yeakey, Anne, additional, Ferron-Brady, Geraldine, additional, Figueroa, David J., additional, Kremer, Brandon E., additional, Gupta, Ira, additional, and Janowski, Wojciech, additional

Published
2021
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39. P-202: Characterization of ocular adverse events in patients receiving Belantamab Mafadotin for ≥12 months: post-hoc analysis of DREAMM-2 study in relapsed/refractory Multiple Myeloma

Author

Lonial, Sagar, primary, Nooka, Ajay, additional, Thulasi, Praneetha, additional, Badros, Ashraf Z., additional, Jeng, Bennie, additional, Callander, Natalie S., additional, Sborov, Douglas, additional, Zaugg, Brian E., additional, Popat, Rakesh, additional, Esposti, Simona Degli, additional, Baron, January, additional, Doherty, Allison, additional, Lewis, Eric, additional, Opalinska, Joanna, additional, Paka, Prani, additional, Piontek, Trisha, additional, Gupta, Ira, additional, Farooq, Asim V., additional, and Jakubowiak, Andrzej, additional

Published
2021
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40. P-212: DREAMM-5 platform trial: Belantamab mafodotin (belamaf; GSK2857916) in combination with five different novel agents in patients with relapsed/refractory multiple myeloma (RRMM)

Author

Richardson, Paul G., primary, Trudel, Suzanne, additional, Callander, Natalie S., additional, Nooka, Ajay, additional, Song, Kevin, additional, Uttervall, Katarina, additional, Minnema, Monique C., additional, Rodríguez-Otero, Paula, additional, Struemper, Herbert, additional, Yeakey, Anne, additional, de Oca, Rocio Montes, additional, Smith, L. Mary, additional, Jackson, Nicola, additional, Kaisermann, Morrys, additional, Im, Ellie, additional, Basile, Frank G., additional, Ahlers, Christoph M., additional, Holkova, Beata, additional, Gupta, Ira, additional, Kremer, Brandon E., additional, and Quach, Hang, additional

Published
2021
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41. P-219: Relationship between corneal exam findings, best-corrected visual acuity, and ocular symptoms in patients with relapsed or refractory multiple myeloma receiving belantamab mafodotin

Author

Terpos, Evangelos, primary, Badros, Ashraf Z., additional, Popat, Rakesh, additional, Rodríguez-Otero, Paula, additional, Farooq, Asim V., additional, Jeng, Bennie, additional, Esposti, Simona Degli, additional, Lewis, Eric, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, Palumbo, Antonio, additional, Trudel, Suzanne, additional, and Jadhav, Vinay, additional

Published
2021
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42. Poster: MM-078: Characterization of Ocular Adverse Events in Patients Receiving Belantamab Mafodotin (Belamaf) for ≥ 12 Months: Post Hoc Analysis of DREAMM-2 Study in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Lonial, Sagar, primary, Nooka, Ajay K., additional, Thulasi, Praneetha, additional, Badros, Ashraf Z., additional, Jeng, Bennie H., additional, Callander, Natalie S., additional, Sborov, Douglas, additional, Zaugg, Brian E., additional, Popat, Rakesh, additional, Esposti, Simona Degli, additional, Baron, January, additional, Doherty, Allison, additional, Lewis, Eric, additional, Opalinska, Joanna, additional, Paka, Prani, additional, Piontek, Trisha, additional, Gupta, Ira, additional, Farooq, Asim V., additional, and Jakubowiak, Andrzej, additional

Published
2021
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43. MM-103: Relationship Between Corneal Exam Findings, Best-Corrected Visual Acuity (BCVA), and Ocular Symptoms in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) Receiving Belantamab Mafodotin (GSK2857916; Belamaf)

Author

Terpos, Evangelos, primary, Badros, Ashraf, additional, Popat, Rakesh, additional, Rodriguez-Otero, Paula, additional, Farooq, Asim, additional, Jeng, Bennie, additional, Esposti, Simona Degli, additional, Lewis, Eric, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, Palumbo, Antonio, additional, and Trudel, Suzanne, additional

Published
2021
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44. Poster: MM-103: Relationship Between Corneal Exam Findings, Best-Corrected Visual Acuity (BCVA), and Ocular Symptoms in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) Receiving Belantamab Mafodotin (GSK2857916; Belamaf)

Author

Terpos, Evangelos, primary, Badros, Ashraf, additional, Popat, Rakesh, additional, Rodriguez-Otero, Paula, additional, Farooq, Asim, additional, Jeng, Bennie, additional, Esposti, Simona Degli, additional, Lewis, Eric, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, Palumbo, Antonio, additional, and Trudel, Suzanne, additional

Published
2021
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45. MM-078: Characterization of Ocular Adverse Events in Patients Receiving Belantamab Mafodotin (Belamaf) for ≥12 Months: Post Hoc Analysis of DREAMM-2 Study in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Lonial, Sagar, primary, Nooka, Ajay K., additional, Thulasi, Praneetha, additional, Badros, Ashraf Z., additional, Jeng, Bennie H., additional, Callander, Natalie S., additional, Sborov, Douglas, additional, Zaugg, Brian E., additional, Popat, Rakesh, additional, Esposti, Simona Degli, additional, Baron, January, additional, Doherty, Allison, additional, Lewis, Eric, additional, Opalinska, Joanna, additional, Paka, Prani, additional, Piontek, Trisha, additional, Gupta, Ira, additional, Farooq, Asim V., additional, and Jakubowiak, Andrzej, additional

Published
2021
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47. Minimal residual disease in Myeloma: Application for clinical care and new drug registration

Author

Anderson, Kenneth, Auclair, Daniel, Adam, Stacey J., Agarwal, Amit, Anderson, Melissa, Avet-Loiseau, Hervé, Bustoros, Mark, Chapman, Jessica, Connors, Dana E., Dash, Ajeeta B., Di Bacco, Alessandra, Du, Ling, Facon, Thierry, Flores-Montero, Juan, Gay, Francesca, Ghobrial, Irene M., Gormley, Nicole J., Gupta, Ira, Higley, Howard, Hillengass, Jens, Kanapuru, Bindu, Kazandjian, Dickran, Kelloff, Gary J., Kirsch, Ilan R., Kremer, Brandon, Landgren, Ola, Lightbody, Elizabeth, Lomas, Oliver C., Lonial, Sagar, Mateos, Maria Victoria, Montes de Oca, Rocío, Mukundan, Lata, Munshi, Nikhil, O’Donnell, Elizabeth K., Orfao, Alberto, Paiva, Bruno, Patel, Reshma, Pugh, Trevor J., Ramasamy, Karthik, Ray, Jill, Roshal, Mikhail, Ross, J. A., Sigman, Caroline C., Thoren, Katie L., Trudel, Suzanne, Ulaner, Gary, Valente, Nancy, Weiss, Brendan M., Zamagni, Elena, and Kumar, S.

Abstract

The development of novel agents has transformed the treatment paradigm for multiple myeloma, with minimal residual disease (MRD) negativity now achievable across the entire disease spectrum. Bone marrow–based technologies to assess MRD, including approaches using next-generation flow and next-generation sequencing, have provided real-time clinical tools for the sensitive detection and monitoring of MRD in patients with multiple myeloma. Complementary liquid biopsy–based assays are now quickly progressing with some, such as mass spectrometry methods, being very close to clinical use, while others utilizing nucleic acid–based technologies are still developing and will prove important to further our understanding of the biology of MRD. On the regulatory front, multiple retrospective individual patient and clinical trial level meta-analyses have already shown and will continue to assess the potential of MRD as a surrogate for patient outcome. Given all this progress, it is not surprising that a number of clinicians are now considering using MRD to inform real-world clinical care of patients across the spectrum from smoldering myeloma to relapsed refractory multiple myeloma, with each disease setting presenting key challenges and questions that will need to be addressed through clinical trials. The pace of advances in targeted and immune therapies in multiple myeloma is unprecedented, and novel MRD-driven biomarker strategies are essential to accelerate innovative clinical trials leading to regulatory approval of novel treatments and continued improvement in patient outcomes.

Published
2021

48. Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration

Author

Anderson, Kenneth C., primary, Auclair, Daniel, additional, Adam, Stacey J., additional, Agarwal, Amit, additional, Anderson, Melissa, additional, Avet-Loiseau, Hervé, additional, Bustoros, Mark, additional, Chapman, Jessica, additional, Connors, Dana E., additional, Dash, Ajeeta, additional, Di Bacco, Alessandra, additional, Du, Ling, additional, Facon, Thierry, additional, Flores-Montero, Juan, additional, Gay, Francesca, additional, Ghobrial, Irene M., additional, Gormley, Nicole J., additional, Gupta, Ira, additional, Higley, Howard, additional, Hillengass, Jens, additional, Kanapuru, Bindu, additional, Kazandjian, Dickran, additional, Kelloff, Gary J., additional, Kirsch, Ilan R., additional, Kremer, Brandon, additional, Landgren, Ola, additional, Lightbody, Elizabeth, additional, Lomas, Oliver C., additional, Lonial, Sagar, additional, Mateos, María-Victoria, additional, Montes de Oca, Rocio, additional, Mukundan, Lata, additional, Munshi, Nikhil C., additional, O'Donnell, Elizabeth K., additional, Orfao, Alberto, additional, Paiva, Bruno, additional, Patel, Reshma, additional, Pugh, Trevor J., additional, Ramasamy, Karthik, additional, Ray, Jill, additional, Roshal, Mikhail, additional, Ross, Jeremy A., additional, Sigman, Caroline C., additional, Thoren, Katie L., additional, Trudel, Suzanne, additional, Ulaner, Gary, additional, Valente, Nancy, additional, Weiss, Brendan M., additional, Zamagni, Elena, additional, and Kumar, Shaji K., additional

Published
2021
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49. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design

Author

Nooka, Ajay K, primary, Weisel, Katja, additional, van de Donk, Niels WCJ, additional, Routledge, David, additional, Otero, Paula Rodriguez, additional, Song, Kevin, additional, Quach, Hang, additional, Callander, Natalie, additional, Minnema, Monique C, additional, Trudel, Suzanne, additional, Jackson, Nicola A, additional, Ahlers, Christoph M, additional, Im, Ellie, additional, Cheng, Shinta, additional, Smith, L, additional, Hareth, Nahi, additional, Ferron-Brady, Geraldine, additional, Brouch, Maria, additional, Montes de Oca, Rocio, additional, Paul, Sofia, additional, Holkova, Beata, additional, Gupta, Ira, additional, Kremer, Brandon E, additional, and Richardson, Paul, additional

Published
2021
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50. Tagraxofusp in Combination with Azacitidine and Venetoclax in Newly Diagnosed CD123+ Acute Myeloid Leukemia, Expansion Cohort of a Phase 1b Multicenter Trial

Author

Lane, Andrew A., Garcia, Jacqueline S., Raulston, Evangeline G., Garzon, Jada L., Galinsky, Ilene, Baxter, Emilie W., Leonard, Rebecca, DeAngelo, Daniel J., Luskin, Marlise R., Reilly, Christopher R., Stahl, Maximilian, Stone, Richard M, Vedula, Rahul, Wadleigh, Martha, Winer, Eric S., Mughal, Tariq, Brooks, Christopher, Gupta, Ira V., Stevenson, Kristen E., Neuberg, Donna S., Ren, Siyang, Konopleva, Marina Y., Stein, Anthony, and Pemmaraju, Naveen

Published
2023
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