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1. Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.

Author

White, Darrell, Schiller, Gary, Madan, Sumit, Lentzsch, Suzanne, Chubar, Evgeni, Lavi, Noa, Van Domelen, Dane, Bentur, Ohad, and Baljevic, Muhamed

Subjects
once weekly dose, optimal triplet combination, pomalidomide, relapsed/refractory multiple myeloma, selinexor
Abstract

OBJECTIVE: To identify the optimal dose of selinexor in combination with pomalidomide and dexamethasone (SPd). METHODS: An analysis of efficacy and safety of 2 once-weekly selinexor regimens (60 mg and 40 mg) with pomalidomide and dexamethasone (SPd-60 and SPd-40, respectively) given to patients with relapsed/refractory multiple myeloma (RRMM) in the STOMP (NCT02343042) and XPORT-MM-028 (NCT04414475) trials. RESULTS: Twenty-eight patients (60.7% males, median age 67.5 years) and 20 patients (35.0% males, median age 65.5 years) were analyzed in the SPd-40 and SPd-60 cohorts, respectively. Overall response rate was 50% (95% confidence interval [CI] 30.6-69.4%) and 65% (95% CI 40.8-84.6%), respectively. Very good partial response or better was reported in 28.6% (95% CI 13.2-48.7%) and 30.0% (95% CI 11.9-54.3%) of patients, respectively. Among 27 responders in both cohorts, the 12-month sustained response rate was 83.3% (95% CI 64.7-100.0%) for SPd-40 and 28.1% (95% CI 8.9-88.8%) for SPd-60. Median progression-free survival was 18.4 months (95% CI 6.5 months, not evaluable [NE]) and 9.5 months (95% CI 7.6 months-NE) for SPd-40 and SPd-60, respectively. Twenty-four-month survival rates were 64.2% (95% CI 47.7-86.3%) for SPd-40 and 51.1% (95% CI 29.9-87.5%) for SPd-60. Treatment-emergent adverse events (TEAEs) included neutropenia (all grades: SPd-40 64.3% versus SPd-60 75.0%), anemia (46.4% versus 65.0%), thrombocytopenia (42.9% versus 45.0%), fatigue (46.4% versus 75.0%), nausea (32.1% versus 70.0%) and diarrhea (28.6% versus 35.0%). CONCLUSION: The all-oral combination of SPd exhibited preliminary signs of efficacy and was generally tolerable in patients with RRMM. The overall risk-benefit profile favored the SPd-40 regimen.

Published
2024

2. Tear Film Hyperosmolarity is Associated with Increased Variation of Light Scatter Following Cataract Surgery.

Author

Sullivan, Benjamin, Palazón de la Torre, Marta, Yago, Ines, Duarte, Raúl, Schallhorn, Julie, Nijm, Lisa, White, Darrell, Berg, Michael, and Artal, Pablo

Subjects
TBUT, cataract, hyperosmolarity, light scatter, staining, tear film
Abstract

PURPOSE: To study the association between tear film hyperosmolarity and ocular light scatter in a cataract surgery population. PATIENTS AND METHODS: Contiguous, 20-second objective scatter index (OSI) scans were recorded in hyperosmolar (≥320 mOsm/L) and normal subjects (

Published
2024

5. Matching-adjusted indirect comparison of phase 3 clinical trial outcomes of OC-01 (varenicline solution) nasal spray and lifitegrast 5% ophthalmic solution for the treatment of dry eye disease.

Author

White, Darrell, Hendrix, Laura, Sun, Lucille, Tam, Iris, Macsai, Marian, and Gibson, Andrea

Subjects
Humans, Data Collection, Dry Eye Syndromes, Nasal Sprays, Ophthalmic Solutions, Treatment Outcome, Varenicline
Abstract

BACKGROUND: Matching-adjusted indirect comparison (MAIC) is a methodology for cross-study comparisons after adjusting for baseline characteristic imbalances. It is a comparative analytical approach used across therapeutic areas absent head-to-head trial outcomes. OBJECTIVE: To compare the efficacy of OC-01 (varenicline solution) 0.03 mg nasal spray (OC-01 VNS) to lifitegrast 5% ophthalmic solution on tear production and patient-reported eye dryness in patients with dry eye disease (DED) using data from phase 3 clinical trials via MAIC analysis. METHODS: Individual patient data (IPD) from the phase 3 registrational trial of OC-01 VNS and aggregate data from 2 phase 3 trials of lifitegrast in the publicly available XIIDRA New Drug Application were used. Using unanchored MAIC methods, IPD were weighted on clinically relevant baseline variables (age, race, sex, baseline Schirmers test score [STS], and Eye Dryness Score [EDS]) to produce weighted OC-01 VNS datasets matched to the same lifitegrast datasets variables. Least-squares (LS) mean change from baseline (CFB) in STS for OC-01 VNS was calculated using the identical analysis of covariance model and covariates used to calculate the same values for lifitegrast in the XIIDRA New Drug Application and was then compared. LS mean EDS (based on a 100- point Visual Analogue Scale) was compared via analysis of covariance in the weighted OC-01 VNS and lifitegrast datasets. OC-01 VNS at 2 and 4 weeks compared to lifitegrast data at 2 and 6 weeks. RESULTS: Data from 511 subjects (n = 260 treated; 251 vehicle control [VC]) in the OC-01 VNS phase 3 trial, 588 (n = 293 treated, 295 VC) in the lifitegrast phase 3 OPUS-1 trial, and 718 (n = 358 treated, 360 VC) in the lifitegrast phase 3 OPUS-2 trial were analyzed. The LS mean STS CFB for OC-01 VNS at 2 and 4 weeks was significantly greater than that for lifitegrast at 2 and 6 weeks in OPUS-1 and OPUS-2 (P < 0.0001 for all comparisons). The LS mean EDS CFB for OC-01 VNS at 2 and 4 weeks was significantly greater than that for lifitegrast at 2 and 6 weeks in OPUS-1 (P < 0.0001 for both comparisons) and at 4 weeks vs lifitegrast at 6 weeks in OPUS-2 (P < 0.0001). CONCLUSIONS: This MAIC analysis demonstrates OC-01 VNS produced significantly greater improvement in mean STS and comparable or greater improvement in EDS compared with lifitegrast in phase 3 trials. These findings suggest a potentially greater magnitude of improvement achieved with OC-01 VNS compared with lifitegrast for the treatment of DED within the conditions of the analysis methodology. DISCLOSURES D White is a consultant for Oyster Point Pharma, Inc. L Hendrix, M Macsai, and A Gibson are employees and shareholders for Oyster Point Pharma, Inc. L Sun was an employee of COEUS, Clinical Research at the time of study conduct and received funding from Oyster Point Pharma, Inc. I Tam is an employee of COEUS, Clinical Research and received funding from Oyster Point Pharma, Inc. Oyster Point Pharma, Inc was involved in the study design, data collection, data analysis, and preparation of the manuscript and is the manufacturer/licensee of OC-01 (varenicline solution) nasal spray. Oyster Point Pharma, Inc., sponsored the phase 3 OC-01 (varenicline solution) clinical study from which analysis data were obtained.

Published
2023

6. 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

7. Tandem Autologous Stem Cell Transplantation Does Not Benefit High-Risk Myeloma Patients in the Maintenance Era: Real-World Results from The Canadian Myeloma Research Group Database

Author

Venner, Christopher P., Duggan, Peter, Song, Kevin, Reece, Donna, Sharma, Smriti, Su, Jiandong, Jimenez-Zepeda, Victor H., McCurdy, Arleigh, Louzada, Martha, Mian, Hira, Sebag, Michael, White, Darrell, Stakiw, Julie, Kotb, Rami, Aslam, Muhammad, Reiman, Anthony, Gul, Engin, Chu, Michael P., Bergstrom, Debra, and LeBlanc, Richard

Published
2024
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8. 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

9. Real-world results of autologous stem cell transplantation in newly diagnosed multiple myeloma: a report from the Canadian Myeloma Research Group database

Author

Côté, Julie, LeBlanc, Richard, Mian, Hira, Chu, Michael P., McCurdy, Arleigh, Masih-Khan, Esther, Su, Jiandong, Jimenez-Zepeda, Victor H., Song, Kevin, Louzada, Martha, White, Darrell, Sebag, Michael, Reiman, Anthony, Stakiw, Julie, Kotb, Rami, Bergstrom, Debra, Aslam, Muhammad, Kaedbey, Rayan, Venner, Christopher P., Gul, Engin, and Reece, Donna

Published
2023
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12. Why Dry Eye Screenings Need to be a Part of Routine Eye Examinations

Author

White, Darrell E.

Subjects
Eye diseases -- Reports, Eye -- Medical examination, Health, Xiidra (Medication) -- Reports, Miebo (Medication) -- Reports
Abstract

There are approximately 150 million adults in the United States who deal with symptoms of dry eye. But it can be difficult to identify as patients often fail to report [...]

Published
2024

13. Daratumumab, lenalidomide, and dexamethasone in relapsed/refractory myeloma: a cytogenetic subgroup analysis of POLLUX.

Author

Kaufman, Jonathan, Dimopoulos, Meletios, White, Darrell, Benboubker, Lotfi, Cook, Gordon, Leiba, Merav, Morton, James, Joy Ho, P, Kim, Kihyun, Takezako, Naoki, Moreau, Philippe, Sutherland, Heather, Magen, Hila, Iida, Shinsuke, Kim, Jin, Miles Prince, H, Cochrane, Tara, Oriol, Albert, Bahlis, Nizar, Chari, Ajai, ORourke, Lisa, Trivedi, Sonali, Casneuf, Tineke, Krevvata, Maria, Ukropec, Jon, Kobos, Rachel, Avet-Loiseau, Hervé, Usmani, Saad, and San-Miguel, Jesus

Subjects
Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Chromosome Deletion, Chromosomes, Human, Cytogenetic Analysis, Dexamethasone, Disease-Free Survival, Humans, Lenalidomide, Multiple Myeloma, Recurrence, Survival Rate, Translocation, Genetic
Abstract

High cytogenetic risk abnormalities confer poor outcomes in multiple myeloma patients. In POLLUX, daratumumab/lenalidomide/dexamethasone (D-Rd) demonstrated significant clinical benefit versus lenalidomide/dexamethasone (Rd) in relapsed/refractory multiple myeloma (RRMM) patients. We report an updated subgroup analysis of POLLUX based on cytogenetic risk. The cytogenetic risk was determined using fluorescence in situ hybridization/karyotyping; patients with high cytogenetic risk had t(4;14), t(14;16), or del17p abnormalities. Minimal residual disease (MRD; 10-5) was assessed via the clonoSEQ® assay V2.0. 569 patients were randomized (D-Rd, n = 286; Rd, n = 283); 35 (12%) patients per group had high cytogenetic risk. After a median follow-up of 44.3 months, D-Rd prolonged progression-free survival (PFS) versus Rd in standard cytogenetic risk (median: not estimable vs 18.6 months; hazard ratio [HR], 0.43; P

Published
2020

14. 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

15. Survival and Outcomes of Newly Diagnosed Multiple Myeloma Patients Stratified by Transplant Status 2007-2018: Retrospective Analysis from the Canadian Myeloma Research Group Database

Author

Mian, Hira, Reece, Donna, Masih-Khan, Esther, McCurdy, Arleigh, Kardjadj, Moustafa, Jimenez-Zepeda, Victor H, Song, Kevin, Louzada, Martha, LeBlanc, Richard, Sebag, Michael, White, Darrell, Stakiw, Julie, Reiman, Anthony, Kotb, Rami, Aslam, Muhammad, Gul, Engin, and Venner, Christopher P.

Published
2022
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16. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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17. Recommendations for the effective use of T-cell–redirecting therapies: a Canadian consensus statement.

Author

Lancman, Guido, Song, Kevin, White, Darrell, Crosbie, Tina, Sharif, Ismail, Emond, Marianne, Saleem Raza, Muhammad, Elias, Martine, Kaedbey, Rayan, and Chu, Michael P.

Abstract

Background: T-cell–redirecting therapies, such as bispecific antibodies and chimeric antigen receptor T-cells, exploit the cytotoxic capabilities of the immune system to destroy cells expressing specific surface antigens, including malignant cells. These therapies have demonstrated unprecedented rates, depth, and duration of responses in relapsed and refractory multiple myeloma. However, there are significant challenges in implementing these therapies into practice, which require multidisciplinary and multicenter coordination and significant healthcare resources to effectively manage these patients. So far, there are no Canadian guidelines for the effective implementation and use of T-cell–redirecting therapies. Methods: This consensus statement was developed based on three advisory meetings held in March, July, and November 2023. During these meetings, a panel of Canadian subject matter experts and representation from Myeloma Canada gathered to discuss the optimal procedures for the use of T-cell–redirecting therapies in the treatment of multiple myeloma. Members of the panel performed a thorough review of randomized clinical trials, real-world data, and other current literature, and provided their up-to-date clinical experience with T-cell–redirecting therapies in Canadian practice settings. Subsequently, asynchronous working groups were appointed to develop unified criteria for patient selection, appraise referral pathways, and devise strategies for management of short-term and long-term adverse events arising from the use of T-cell–redirecting therapies in multiple myeloma. Results: Here, we present recommendations for optimizing patient selection, referral pathways, and adverse event management in the Canadian practice setting. These recommendations are relevant for hematologists/oncologists, oncology nurses, pharmacists, nurse practitioners, physician assistants, and other providers who treat patients with multiple myeloma, as well as individuals with multiple myeloma and their care partners. These recommendations will be of interest to clinicians who treat patients with MM at community clinics and hospitals and who may be interested in referring patients for T-cell–redirecting therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Disease Characteristics and Outcomes of 493 Young Myeloma Patients Treated With Modern Therapies: A Canadian Myeloma Research Group Database Study.

Author

Tanguay, Mégane, Roy, Jean, Su, Jiandong, Gul, Engin, Reece, Donna, Venner, Christopher P., White, Darrell, Chu, Michael P., Jimenez‐Zepada, Victor H., Song, Kevin, Mccurdy, Arleigh, Mian, Hira, Sebag, Michael, Bergstrom, Debra, Stakiw, Julie, Reiman, Anthony, Kotb, Rami, Aslam, Muhammad, Kaedbey, Rayan, and Louzada, Martha

Subjects
PLASMA cell leukemia, STEM cell transplantation, STEM cell treatment, MULTIPLE myeloma, OVERALL survival
Abstract

Background: Young patients ≤ 50 years old with multiple myeloma (MM) account for about 10% of cases and are underrepresented in the literature. Methods: We explored disease characteristics, treatments, and outcomes following modern therapies of young MM patients using the Canadian Myeloma Research Group (CMRG) database. We included 493 patients ≤ 50 years old diagnosed with MM or plasma cell leukemia without concurrent amyloidosis or POEMS syndrome from January 1, 2010, to July 1, 2022. Results: The median age was 46 years old (range: 25.6–50). Most patients fell into the R‐ISS II category (72.7%), and 24.1% had high‐risk cytogenetics. The majority of patients (89.9%) received a proteasome inhibitor‐based first‐line treatment, 92.1% received a stem cell transplant, and 65.6% had maintenance therapy post–autologous stem cell transplant (ASCT). Median follow‐up from initial treatment to patients' last follow‐up was 48.5 (range: 0–155) months. Median progression‐free survival (PFS) was 45.0 months (95% CI: 40.2–50.0). Maintenance therapy post‐ASCT improved median PFS to 52.3 months (95% CI: 43.1–68.2), compared to 23.6 months (95% CI: 20.0–34.8) without maintenance [p < 0.001]. Conclusion: Although the overall survival has not yet been reached in this young population, our reported median PFS of only 45 months highlights the urgent need to develop innovative treatments to induce more profound and durable responses. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX.

Author

Dimopoulos, Meletios, San-Miguel, Jesus, Belch, Andrew, White, Darrell, Benboubker, Lotfi, Cook, Gordon, Leiba, Merav, Morton, James, Ho, P, Kim, Kihyun, Takezako, Naoki, Moreau, Philippe, Kaufman, Jonathan, Sutherland, Heather, Lalancette, Marc, Magen, Hila, Iida, Shinsuke, Kim, Jin, Prince, H, Cochrane, Tara, Oriol, Albert, Bahlis, Nizar, Chari, Ajai, ORourke, Lisa, Wu, Kaida, Schecter, Jordan, Casneuf, Tineke, Chiu, Christopher, Soong, David, Sasser, A, Khokhar, Nushmia, Avet-Loiseau, Hervé, and Usmani, Saad

Subjects
Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Drug Resistance, Neoplasm, Female, Humans, Kaplan-Meier Estimate, Lenalidomide, Male, Middle Aged, Multiple Myeloma, Neoplasm Recurrence, Local, Neoplasm, Residual, Outcome Assessment, Health Care
Abstract

In the POLLUX study, daratumumab plus lenalidomide/dexamethasone significantly reduced risk of progression/death versus lenalidomide/dexamethasone alone in relapsed/refractory multiple myeloma. We provide one additional year of follow up and include the effect on minimal residual disease and in clinically relevant subgroups. After 25.4 months of follow up, daratumumab plus lenalidomide/dexamethasone prolonged progression-free survival versus lenalidomide/dexamethasone alone (median not reached vs 17.5 months; hazard ratio, 0.41; 95% confidence interval, 0.31-0.53; P12 and ≤12 months and >6 and ≤6 months. No new safety signals were observed. In relapsed/refractory multiple myeloma patients, daratumumab plus lenalidomide/dexamethasone continued to improve progression-free survival and deepen responses versus lenalidomide/dexamethasone. Trial Registration: clinicaltrials.gov identifier: 02076009.

Published
2018

22. Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma

Author

Facon, Thierry, Venner, Christopher P., Bahlis, Nizar J., Offner, Fritz, White, Darrell J., Karlin, Lionel, Benboubker, Lotfi, Rigaudeau, Sophie, Rodon, Philippe, Voog, Eric, Yoon, Sung-Soo, Suzuki, Kenshi, Shibayama, Hirohiko, Zhang, Xiaoquan, Twumasi-Ankrah, Philip, Yung, Godwin, Rifkin, Robert M., Moreau, Philippe, Lonial, Sagar, Kumar, Shaji K., Richardson, Paul G., and Rajkumar, S. Vincent

Published
2021
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23. Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse

Author

Dimopoulos, Meletios, Weisel, Katja, Moreau, Philippe, Anderson, Jr, Larry D., White, Darrell, San-Miguel, Jesus, Sonneveld, Pieter, Engelhardt, Monika, Jenner, Matthew, Corso, Alessandro, Dürig, Jan, Pavic, Michel, Salomo, Morten, Casal, Eva, Srinivasan, Shankar, Yu, Xin, Nguyen, Tuong Vi, Biyukov, Tsvetan, Peluso, Teresa, and Richardson, Paul

Published
2021
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24. Tear Film Hyperosmolarity is Associated with Increased Variation of Light Scatter Following Cataract Surgery.

Author

Sullivan, Benjamin D, de la Torre, Marta Palazón, Yago, Ines, Duarte, Raúl, Schallhorn, Julie M, Nijm, Lisa M, White, Darrell E, Berg, Michael S, and Artal, Pablo

Subjects
LIGHT scattering, MEIBOMIAN glands, CATARACT surgery, MEDICAL screening, CATARACT
Abstract

Objective scatter index (OSI) scans were recorded in hyperosmolar (≥ 320 mOsm/L) and normal subjects (< 308 mOsm/L) with cataract nuclear opacity ≥ 3. OSI was measured at screening, baseline and 90 days following surgery. Along with symptoms of ocular surface disease, slit-lamp examination included corneal staining (0– 3), tear film breakup time (TBUT) and evaluation of meibomian gland disease (MGD). An additional cohort of hyperosmolar subjects were measured for OSI at screening, baseline, and 5, 10, 15 and 30 minutes following instillation of 0.18% sodium hyaluronate (HA). Results: Thirty-one eyes of 31 patients were included. There was a significant difference in post-operative OSI variation when comparing hyperosmolar (0.65± 0.30, N=11) to normal subjects (0.33± 0.11, N=10, p=0.005). Of note, there were no significant differences in OSI variation when subjects were sorted by staining (p=0.9), TBUT (p=0.7), symptoms (p=0.7), or MGD status (p=0.9). Instillation of 0.18% HA (N=10) did not alter OSI at 5 minutes, but significant reductions in OSI of 28.8%, 38.5% and 36.7% (all p < 0.001) were observed at 10, 15 and 30 minutes. Conclusion: Hyperosmolar patients exhibited significantly increased variation in light scatter following cataract surgery that was undifferentiated by staining or TBUT. Elevated osmolarity may be indicative of light scatter equivalent to that of a grade 2– 3 cataract. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial

Author

Grosicki, Sebastian, Simonova, Maryana, Spicka, Ivan, Pour, Ludek, Kriachok, Iryrna, Gavriatopoulou, Maria, Pylypenko, Halyna, Auner, Holger W, Leleu, Xavier, Doronin, Vadim, Usenko, Ganna, Bahlis, Nizar J, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan K, Sinha, Dinesh K, Venner, Christopher P, Garg, Mamta, Gironella, Mercedes, Jurczyszyn, Artur, Robak, Pawel, Galli, Monica, Wallington-Beddoe, Craig, Radinoff, Atanas, Salogub, Galina, Stevens, Don A, Basu, Supratik, Liberati, Anna M, Quach, Hang, Goranova-Marinova, Vesselina S, Bila, Jelena, Katodritou, Eirini, Oliynyk, Hanna, Korenkova, Sybiryna, Kumar, Jeevan, Jagannath, Sundar, Moreau, Phillipe, Levy, Moshe, White, Darrell, Gatt, Moshe E, Facon, Thierry, Mateos, Maria V, Cavo, Michele, Reece, Donna, Anderson, Larry D, Jr, Saint-Martin, Jean-Richard, Jeha, Jacqueline, Joshi, Anita A, Chai, Yi, Li, Lingling, Peddagali, Vishnuvardhan, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G, Dimopoulos, Meletios A, Richardson, Paul G, and Delimpasi, Sosana

Published
2020
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26. Consensus Guidelines on the Diagnosis of Multiple Myeloma and Related Disorders: Recommendations of the Myeloma Canada Research Network Consensus Guideline Consortium

Author

Côté, Julie, LeBlanc, Richard, Reiman, Anthony, Sebag, Michael, Song, Kevin W., Colasurdo, Gabriele, Del Col, Aldo, McMullen, David, Hay, Annette E., Laferriere, Nicole M.B., Robertson McCurdy, Arleigh B., Roy, Jean, Stakiw, Julie L., Trudel, Suzanne M., White, Darrell J., Loveys, Fraser W., Randell, Edward, Rizkalla, Kamilia S., Bergstrom, Debra J., Kotb, Rami, Louzada, Martha L., Sutherland, Heather J., Tavoularis, Sofia, and Venner, Christopher P.

Published
2020
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27. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial

Author

Mateos, Maria-Victoria, Nahi, Hareth, Legiec, Wojciech, Grosicki, Sebastian, Vorobyev, Vladimir, Spicka, Ivan, Hungria, Vania, Korenkova, Sibirina, Bahlis, Nizar, Flogegard, Max, Bladé, Joan, Moreau, Philippe, Kaiser, Martin, Iida, Shinsuke, Laubach, Jacob, Magen, Hila, Cavo, Michele, Hulin, Cyrille, White, Darrell, De Stefano, Valerio, Clemens, Pamela L, Masterson, Tara, Lantz, Kristen, O'Rourke, Lisa, Heuck, Christoph, Qin, Xiang, Parasrampuria, Dolly A, Yuan, Zhilong, Xu, Steven, Qi, Ming, and Usmani, Saad Z

Published
2020
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28. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results

Author

Usmani, Saad Z., Mateos, Maria-Victoria, Hungria, Vania, Iida, Shinsuke, Bahlis, Nizar J., Nahi, Hareth, Magen, Hila, Cavo, Michele, Hulin, Cyrille, White, Darrell, De Stefano, Valerio, Fastenau, John, Slavcev, Mary, Heuck, Christoph, Qin, Xiang, Pei, Huiling, Masterson, Tara, Lantz, Kristen, and Gries, Katharine S.

Published
2021
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29. Selinexor-Based Triplet Regimens in Patients With Multiple Myeloma Previously Treated With Anti-CD38 Monoclonal Antibodies

Author

Schiller, Gary J., Lipe, Brea C., Bahlis, Nizar J., Tuchman, Sascha A., Bensinger, William I., Sutherland, Heather J., Lentzsch, Suzanne, Baljevic, Muhamed, White, Darrell, Kotb, Rami, Chen, Christine I., Rossi, Adriana, Biran, Noa, LeBlanc, Richard, Grosicki, Sebastian, Martelli, Maurizio, Gunsilius, Eberhard, Špička, Ivan, Stevens, Don Ambrose, Facon, Thierry, Mesa, Mercedes Gironella, Zhang, Chris, Van Domelen, Dane R., Bentur, Ohad S., and Gasparetto, Cristina

Published
2023
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31. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study

Author

Bahlis, Nizar J., Dimopoulos, Meletios A., White, Darrell J., Benboubker, Lotfi, Cook, Gordon, Leiba, Merav, Ho, P. Joy, Kim, Kihyun, Takezako, Naoki, Moreau, Philippe, Kaufman, Jonathan L., Krevvata, Maria, Chiu, Christopher, Qin, Xiang, Okonkwo, Linda, Trivedi, Sonali, Ukropec, Jon, Qi, Ming, and San-Miguel, Jesus

Published
2020
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32. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Abildgaard, Niels, Adler, Howard, Altuntas, Fevzi, Akay, Olga Meltem, Amin, Bipinkumar, Anagnostopoulos, Achilleas, Anderson, Larry, Anttila, Pekka, Araujo, Carla, Arce-Lara, Carlos, Aydin, Yildiz, Basu, Supratik, Battini, Ramakrishna, Beeker, Thaddeus, Benboubker, Lotfi, Ben-Yehuda, Dina, Bladé, Joan, Blau, Igor Wolfgang, Boccia, Ralph, Burke, Lillian, Byeff, Peter, Cascavilla, Nicola, Cavo, Michele, Chantry, Andrew, Charles, Yen, Chaudhry, Arvind, Corso, Alessandro, Coyne, Mark, De Arriba, Felipe, Delimpasi, Sosana, Desjardins, Pierre, Dhakal, Binod, Di Bartolomeo, Paolo, Di Raimondo, Francesco, Dürig, Jan, Engelhardt, Monika, Escoffre-Barbe, Martine, Esteves, Graca, Flogegard, Max, Gabrail, Nashat, Gamberi, Barbara, Garrison, Mitchell, Gay, Julie, Gisslinger, Heinz, Goldschmidt, Hartmut, Goncalves, Cristina, Gressot, Laurent, Grosicki, Sebastian, Hanna, Wahid, Hayden, Patrick, Henriques Bernardo, Maria Manuela, Hermann, Robert, Holden, Viran, Honkalehto, Kirsti, Huben, Marianne, Huffman, John, Hunter, Hannah, Hus, Marek, Jagasia, Madan, Jagganath, Sundar, Janakiram, Murali, Jaiyesimi, Ishmael, Jenner, Matthew, João, Cristina, Johnson, Peter, Jurcyszyn, Artur, Kalayoğlu Beşişik, Sevgi, Kambhampati, Suman, Kanate, Abraham, Karadoğan, Ihsan, Khojasteh, Ali, Kirkel, Dean, Komarnicki, Mieczyslaw, Krauth, Maria-Theresa, Kuriakose, Phillip, Larocca, Alessandra, Lauri, Birgitta, Leleu, Xavier, Lucio, Paulo, Luppi, Mario, Mangiacavalli, Silvia, Mariette, Clara, Matsue, Kosei, Mellqvist, Ulf-Henri, Mendeleeva, Larisa, Meshad, Michael, Miller, Carole, Mohrbacher, Ann, Moreau, Philippe, Morelli, Anna Maria, Müldür, Ercan, Naassan, Anthony, Nahi, Hareth, Nair, Rajesh, O'Dwyer, Mike, Öngören Aydin, Seniz, Openshaw, Thomas, O'Rourke, Timothy, Osswald, Michael, Overton, Lindsay, Pati, Asmin, Pavic, Michel, Pegourie, Brigitte, Pehlivan, Mustafa, Pierola, Ana Alfonso, Plesner, Torben, Pluta, Andrzej, Rabin, Neil, Ramasamy, Karthik, Rambaldi, Alessandro, Rodriguez, Paula, Röllig, Christoph, Rosenblatt, Jacalyn, Rosenbluth, Jonathan, Salomo, Morten, Samoylova, Olga, Sastre Moral, Jose, Sati, Hamdi, Selleri, Carmine, Shafeek, Salim, Shinagawa, Atsushi, Sleckman, Bethany, Smith, Clay, Sonmez, Mehmet, Stone, Chester, Streetly, Matthew, Suzuki, Kenshi, Taetle, Raymond, Tafuri, Agostino, Takezako, Naoki, Teke, Hava Üsküdar, Vapaatalo, Mirja, Vassilopoulos, George, Verma, Amit, Vidito, Sarah, Viterbo, Luisa, Vural, Filiz, Wang, Xiang Sean, Yağci, Munci, Yee, Andrew, Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, and Dimopoulos, Meletios

Published
2019
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34. Long‐term follow‐up of outcomes including progression‐free survival 2 in patients with transplant‐ineligible multiple myeloma in the real‐world practice: A multi‐institutional report from the Canadian Myeloma Research Group (CMRG) database

Author

Kaedbey, Rayan, Reece, Donna, Venner, Christopher P., McCurdy, Arleigh, Su, Jiandong, Chu, Michael, Louzada, Martha, Jimenez‐Zepeda, Victor H, Mian, Hira, Song, Kevin, Sebag, Michael, Stakiw, Julie, White, Darrell, Reiman, Anthony, Aslam, Muhammad, Kotb, Rami, Bergstrom, Debra, Gul, Engin, and LeBlanc, Richard

Published
2024
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37. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma

Author

Facon, Thierry, Dimopoulos, Meletios A., Dispenzieri, Angela, Catalano, John V., Belch, Andrew, Cavo, Michele, Pinto, Antonello, Weisel, Katja, Ludwig, Heinz, Bahlis, Nizar J., Banos, Anne, Tiab, Mourad, Delforge, Michel, Cavenagh, Jamie D., Geraldes, Catarina, Lee, Je-Jung, Chen, Christine, Oriol, Albert, De La Rubia, Javier, White, Darrell, Binder, Daniel, Lu, Jin, Anderson, Kenneth C., Moreau, Philippe, Attal, Michel, Perrot, Aurore, Arnulf, Bertrand, Qiu, Lugui, Roussel, Murielle, Boyle, Eileen, Manier, Salomon, Mohty, Mohamad, Avet-Loiseau, Herve, Leleu, Xavier, Ervin-Haynes, Annette, Chen, Guang, Houck, Vanessa, Benboubker, Lotfi, and Hulin, Cyrille

Published
2018
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38. P-321 Real-world outcomes in myeloma patients with t(11;14): a matched comparison using the Canadian myeloma research group national clinical database

Author

Varghese, Julia, primary, Venner, Christopher, additional, Louzada, Martha, additional, Reece, Donna, additional, White, Darrell, additional, Su, Jiandong, additional, Chu, Michael, additional, Jimenez-Zepeda, Victor, additional, McCurdy, Arleigh, additional, Song, Kevin, additional, Mian, Hira, additional, Sebag, Michael, additional, Bergstrom, Debra, additional, Stakiw, Julie, additional, Reiman, Anthony, additional, Kotb, Rami, additional, Aslam, Muhammad, additional, Kaedbey, Rayan, additional, Gul, Engin, additional, and LeBlanc, Richard, additional

Published
2023
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39. P-320 Iberdomide (IBER) plus dexamethasone (DEX) in patients with relapsed/refractory multiple myeloma (RRMM): a safety analysis from the CC-220-MM-001 trial

Author

van de Donk, Niels, primary, White, Darrell, additional, Lipe, Brea, additional, Khan, Abdullah, additional, Niesvizky, Ruben, additional, Oriol, Albert, additional, Mesa, Mercedes Gironella, additional, Anwer, Faiz, additional, Bhutani, Manisha, additional, McClune, Brian, additional, Singhal, Seema, additional, Cheng, Yiming, additional, Hamada, Izumi, additional, Jin, Kexin, additional, Solomon, Thomas, additional, Hong, Kevin, additional, Amin, Alpesh, additional, Maciag, Paulo, additional, and Lonial, Sagar, additional

Published
2023
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40. OA-41 Iberdomide, bortezomib, and dexamethasone (IberVd) in transplant-ineligible newly diagnosed multiple myeloma (NDMM): results from the CC-220-MM-001 trial

Author

White, Darrell, primary, Lipe, Brea, additional, Mesa, Mercedes Gironella, additional, Niesvizky, Ruben, additional, Oriol, Albert, additional, Balari, Anna Sureda, additional, Bhutani, Manisha, additional, Encinas, Cristina, additional, Khan, Abdullah, additional, Amatangelo, Michael, additional, Jin, Kexin, additional, Solomon, Thomas, additional, Hong, Kevin, additional, Amin, Alpesh, additional, Maciag, Paulo, additional, van de Donk, Niels, additional, and Lonial, Sagar, additional

Published
2023
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41. OA-49 Mezigdomide (MEZI) plus dexamethasone (DEX) and bortezomib (BORT) or carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): results from the CC-92480-MM-002 trial

Author

Oriol, Albert, primary, Sandhu, Irwindeep, additional, Raab, Marc, additional, White, Darrell, additional, LeBlanc, Richard, additional, Raje, Noopur, additional, Ocio, Enrique, additional, Perrot, Aurore, additional, Facon, Thierry, additional, Rodriguez, Cesar, additional, Waesch, Ralph, additional, Amatangelo, Michael, additional, Zhou, Zehua, additional, Wang, Yue, additional, Civardi, Tiziana, additional, Koo, Philip, additional, Maciag, Paulo, additional, Zhu, Daniel, additional, Katz, Jessica, additional, and Richardson, Paul, additional

Published
2023
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42. Outcome of carfilzomib/pomalidomide‐based regimens after daratumumab‐based treatment in relapsed multiple myeloma: A Canadian Myeloma Research Group Database analysis

Author

LeBlanc, Richard, primary, Mian, Hira, additional, Reece, Donna, additional, Su, Jiandong, additional, Masih‐Khan, Esther, additional, Chu, Michael, additional, Jimenez‐Zepeda, Victor, additional, Sebag, Michael, additional, Song, Kevin, additional, Louzada, Martha, additional, Kotb, Rami, additional, Visram, Alissa, additional, White, Darrell, additional, Stakiw, Julie, additional, Reiman, Antony, additional, Aslam, Muhammad, additional, Bergstrom, Debra, additional, Kaedbey, Rayan, additional, Gul, Engin, additional, and Venner, Christopher, additional

Published
2023
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43. Late versus early response and depth of response are associated with improved outcomes in patients with newly diagnosed multiple myeloma enrolled in the TOURMALINE‐MM2 trial

Author

Richardson, Paul G., primary, Facon, Thierry, additional, Venner, Christopher P., additional, Bahlis, Nizar J., additional, Offner, Fritz, additional, White, Darrell, additional, Karlin, Lionel, additional, Benboubker, Lotfi, additional, Voog, Eric, additional, Yoon, Sung‐Soo, additional, Suzuki, Kenshi, additional, Shibayama, Hirohiko, additional, Zhang, Xiaoquan, additional, Villarreal, Miguel, additional, Twumasi‐Ankrah, Philip, additional, Labotka, Richard, additional, Rifkin, Robert M., additional, Lonial, Sagar, additional, Kumar, Shaji K., additional, Rajkumar, S. Vincent, additional, and Moreau, Philippe, additional

Published
2023
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45. Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study

Author

Dimopoulos, Meletios A., Lonial, Sagar, White, Darrell, Moreau, Philippe, Weisel, Katja, San-Miguel, Jesus, Shpilberg, Ofer, Grosicki, Sebastian, Špička, Ivan, Walter-Croneck, Adam, Magen, Hila, Mateos, Maria-Victoria, Belch, Andrew, Reece, Donna, Beksac, Meral, Spencer, Andrew, Oakervee, Heather, Orlowski, Robert Z., Taniwaki, Masafumi, Röllig, Christoph, Einsele, Hermann, Matsumoto, Morio, Wu, Ka Lung, Anderson, Kenneth C., Jou, Ying-Ming, Ganetsky, Alex, Singhal, Anil K., and Richardson, Paul G.

Published
2020
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47. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma

Author

Janssen Research and Development, Mateos, Maria Victoria, Rigaudeau, Sophie, Basu, Supratik, Špička, Ivan, Schots, Rik, Wrobel, Tomasz, Cook, Gordon, Beksac, Meral, Gries, Katharine S., Kudva, Anupa, Tromp, Brenda, Rampelbergh, Rian Van, Pei, Huiling, Wroblewski, Susan, Carson, Robin, Delioukina, María, White, Darrell, Janssen Research and Development, Mateos, Maria Victoria, Rigaudeau, Sophie, Basu, Supratik, Špička, Ivan, Schots, Rik, Wrobel, Tomasz, Cook, Gordon, Beksac, Meral, Gries, Katharine S., Kudva, Anupa, Tromp, Brenda, Rampelbergh, Rian Van, Pei, Huiling, Wroblewski, Susan, Carson, Robin, Delioukina, María, and White, Darrell

Abstract

[Introduction]: Two phase 3 studies demonstrated superior efficacy of intravenous daratumumab (DARA IV) plus bortezomib/melphalan/prednisone (ALCYONE) or lenalidomide/dexamethasone (Rd; MAIA) versus standard-of-care regimens for transplant-ineligible newly diagnosed multiple myeloma. In these studies, patients could switch from DARA IV to subcutaneous daratumumab (DARA SC) while receiving daratumumab monotherapy in ALCYONE (as of Cycle 11) or daratumumab plus Rd in MAIA. The phase 3 COLUMBA study demonstrated noninferiority of DARA SC to DARA IV. DARA SC reduced administration time, allowing patients to spend less time in healthcare settings, a relevant practical consideration for patient care in the COVID-19 pandemic/settings of limited healthcare resources., [Methods]: DARA SC 1800 mg was administered every 4 weeks, per approved dosing schedules. We evaluated safety and patient-reported experience (ALCYONE only) among patients who switched from DARA IV to DARA SC., [Results]: Fifty-seven patients in ALCYONE and 135 in MAIA switched to DARA SC. Three (2.2%; MAIA) patients reported injection-site reactions, all of which were mild. No infusion-related reactions occurred with DARA SC. In ALCYONE, >80% of patients preferred DARA SC over DARA IV. Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 5.3% of patients in ALCYONE and 25.9% in MAIA; one (0.7%; MAIA) patient experienced a TEAE with an outcome of death., [Conclusion]: For transplant-ineligible newly diagnosed multiple myeloma, DARA SC (monotherapy/with Rd) was safe and preferred over DARA IV. ClinicalTrials.gov, NCT02195479/NCT02252172.

Published
2023

48. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial

Author

Lonial, Sagar, Weiss, Brendan M, Usmani, Saad Z, Singhal, Seema, Chari, Ajai, Bahlis, Nizar J, Belch, Andrew, Krishnan, Amrita, Vescio, Robert A, Mateos, Maria Victoria, Mazumder, Amitabha, Orlowski, Robert Z, Sutherland, Heather J, Bladé, Joan, Scott, Emma C, Oriol, Albert, Berdeja, Jesus, Gharibo, Mecide, Stevens, Don A, LeBlanc, Richard, Sebag, Michael, Callander, Natalie, Jakubowiak, Andrzej, White, Darrell, de la Rubia, Javier, Richardson, Paul G, Lisby, Steen, Feng, Huaibao, Uhlar, Clarissa M, Khan, Imran, Ahmadi, Tahamtan, and Voorhees, Peter M

Published
2016
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49. The Era of 'And': Combination therapy arrives.

Author

White, Darrell E.

Subjects
ANTIBIOTICS, STEROID drugs, COMBINATION drug therapy, ANTI-inflammatory agents, OPHTHALMIC drugs, EMULSIONS, LUBRICATION & lubricants, CYCLOSPORINE, PREDNISOLONE, DRY eye syndromes, IMMUNOMODULATORS, THERAPEUTICS
Published
2024

50. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b–2 dose-escalation study

Author

Richardson, Paul G, Jagannath, Sundar, Moreau, Philippe, Jakubowiak, Andrzej J, Raab, Marc S, Facon, Thierry, Vij, Ravi, White, Darrell, Reece, Donna E, Benboubker, Lotfi, Zonder, Jeffrey, Tsao, L Claire, Anderson, Kenneth C, Bleickardt, Eric, Singhal, Anil K, and Lonial, Sagar

Published
2015
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