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36 results on '"Tromp, Brenda"'

1. Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA

Author

Suzuki, Kenshi, Wechalekar, Ashutosh D., Kim, Kihyun, Shimazaki, Chihiro, Kim, Jin Seok, Ikezoe, Takayuki, Min, Chang-Ki, Zhou, Fude, Cai, Zhen, Chen, Xiaonong, Iida, Shinsuke, Katoh, Nagaaki, Fujisaki, Tomoaki, Shin, Ho-Jin, Tran, NamPhuong, Qin, Xiang, Vasey, Sandra Y., Tromp, Brenda, Weiss, Brendan M., Comenzo, Raymond L., Kastritis, Efstathios, and Lu, Jin

Published
2023
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2. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial

Author

Facon, Thierry, Kumar, Shaji K, Plesner, Torben, Orlowski, Robert Z, Moreau, Philippe, Bahlis, Nizar, Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O'Dwyer, Michael, Perrot, Aurore, Venner, Christopher P, Weisel, Katja, Mace, Joseph R, Raje, Noopur, Tiab, Mourad, Macro, Margaret, Frenzel, Laurent, Leleu, Xavier, Ahmadi, Tahamtan, Wang, Jianping, Van Rampelbergh, Rian, Uhlar, Clarissa M, Tromp, Brenda, Delioukina, Maria, Vermeulen, Jessica, and Usmani, Saad Z

Published
2021
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3. A phase 2, open-label, multicenter study of the long-term safety of siltuximab (an anti-interleukin-6 monoclonal antibody) in patients with multicentric Castleman disease

Author

van Rhee, Frits, Casper, Corey, Voorhees, Peter M, Fayad, Luis E, van de Velde, Helgi, Vermeulen, Jessica, Qin, Xiang, Qi, Ming, Tromp, Brenda, and Kurzrock, Razelle

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Hematology, Rare Diseases, Cardiovascular, Cancer, Clinical Research, Patient Safety, 7.1 Individual care needs, Management of diseases and conditions, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adolescent, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Castleman Disease, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Time Factors, Treatment Outcome, United States, Young Adult, multi-centric Castleman's disease, interleukin-6, siltuximab, clinical trial, Oncology and Carcinogenesis, Oncology and carcinogenesis
Abstract

BACKGROUND:Multicentric Castleman disease (MCD) is a rare, systemic lymphoproliferative disorder driven by interleukin (IL)-6 overproduction. Siltuximab, an anti-IL-6 monoclonal antibody, has demonstrated durable tumor and symptomatic responses in a multinational, randomized, placebo-controlled study of MCD. METHODS:This preplanned safety analysis was conducted to evaluate the long-term safety of siltuximab treatment among 19 patients with MCD who had stable disease or better and were enrolled in a phase-1 study and subsequent ongoing, open-label, phase-2 extension study. Dosing was 11 mg/kg administered intravenously every 3 weeks, per protocol, or every 6 weeks at the investigator's discretion. Safety monitoring focused on potential risks associated with the anti-IL-6 mechanism of action. Investigator-assessed disease control status was also documented. RESULTS:Median treatment duration for the 19 patients was 5.1 (range 3.4, 7.2) years, with 14 (74%) patients treated for >4 years. Grade-≥ 3 adverse events (AEs) reported in >1 patient included hypertension (n = 3) and nausea, cellulitis, and fatigue (n = 2 each). Grade-≥ 3 AEs at least possibly attributed to siltuximab were leukopenia, lymphopenia, and a serious AE of polycythemia (n = 1 each). Hypertriglyceridemia and hypercholesterolemia (total cholesterol) were reported in 8 and 9 patients, respectively. No disease relapses were observed, and 8 of 19 patients were able to switch to an every-6-week dosing schedule. CONCLUSIONS:All MCD patients in this extension study have received siltuximab for a prolonged duration (up to 7 years) without evidence of cumulative toxicity or treatment discontinuations and with few serious infections. All patients are alive, demonstrate sustained disease control, and continue to receive siltuximab.

Published
2015

4. Supplementary Figure 1 from A Phase I/II, Multiple-Dose, Dose-Escalation Study of Siltuximab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Author

Angevin, Eric, primary, Tabernero, Josep, primary, Elez, Elena, primary, Cohen, Steven J., primary, Bahleda, Rastilav, primary, van Laethem, Jean-Luc, primary, Ottensmeier, Christian, primary, Lopez-Martin, Jose A., primary, Clive, Sally, primary, Joly, Florence, primary, Ray-Coquard, Isabelle, primary, Dirix, Luc, primary, Machiels, Jean-Pascal, primary, Steven, Neil, primary, Reddy, Manjula, primary, Hall, Brett, primary, Puchalski, Thomas A., primary, Bandekar, Rajesh, primary, van de Velde, Helgi, primary, Tromp, Brenda, primary, Vermeulen, Jessica, primary, and Kurzrock, Razelle, primary

Published
2023
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5. Supplementary Methods, Table 1 from A Phase I/II, Multiple-Dose, Dose-Escalation Study of Siltuximab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Author

Angevin, Eric, primary, Tabernero, Josep, primary, Elez, Elena, primary, Cohen, Steven J., primary, Bahleda, Rastilav, primary, van Laethem, Jean-Luc, primary, Ottensmeier, Christian, primary, Lopez-Martin, Jose A., primary, Clive, Sally, primary, Joly, Florence, primary, Ray-Coquard, Isabelle, primary, Dirix, Luc, primary, Machiels, Jean-Pascal, primary, Steven, Neil, primary, Reddy, Manjula, primary, Hall, Brett, primary, Puchalski, Thomas A., primary, Bandekar, Rajesh, primary, van de Velde, Helgi, primary, Tromp, Brenda, primary, Vermeulen, Jessica, primary, and Kurzrock, Razelle, primary

Published
2023
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6. Corticosteroid tapering is a safe approach in patients with relapsed or refractory multiple myeloma receiving subcutaneous daratumumab: part 3 of the open-label, multicenter, phase 1b PAVO study

Author

Janssen Research and Development, Nahi, Hareth, Usmani, Saad Z., Mateos, Maria Victoria, Donk, Niels W. C. J. van de, Oriol, Albert, Plesner, Torben, Bandyopadhyay, Nibedita, Hellemans, Peter, Tromp, Brenda, Nnane, Ivo, Zemlickis, Donna, Chari, Ajai, Moreau, Philippe, Janssen Research and Development, Nahi, Hareth, Usmani, Saad Z., Mateos, Maria Victoria, Donk, Niels W. C. J. van de, Oriol, Albert, Plesner, Torben, Bandyopadhyay, Nibedita, Hellemans, Peter, Tromp, Brenda, Nnane, Ivo, Zemlickis, Donna, Chari, Ajai, and Moreau, Philippe

Abstract

Daratumumab is approved as monotherapy and in combination regimens for the treatment of relapsed or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma [Citation1,Citation2]. The PAVO study (ClinicalTrials.gov Identifier: NCT02519452) of daratumumab plus recombinant human hyaluronidase PH20 (rHuPH20; ENHANZE® drug delivery technology, Halozyme, Inc., San Diego, CA) in a mix-and-deliver formulation (part 1) or a pre-mixed subcutaneous formulation (DARA SC; part 2) demonstrated consistent safety, pharmacokinetics, and efficacy as the daratumumab intravenous (IV) formulation in patients with RRMM [Citation3–5].

Published
2023

7. 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

8. Corticosteroid tapering is a safe approach in patients with relapsed or refractory multiple myeloma receiving subcutaneous daratumumab: part 3 of the open-label, multicenter, phase 1b PAVO study

Author

Nahi, Hareth, primary, Usmani, Saad Z., additional, Mateos, Maria-Victoria, additional, van de Donk, Niels W. C. J., additional, Oriol, Albert, additional, Plesner, Torben, additional, Bandyopadhyay, Nibedita, additional, Hellemans, Peter, additional, Tromp, Brenda, additional, Nnane, Ivo, additional, Zemlickis, Donna, additional, Chari, Ajai, additional, and Moreau, Philippe, additional

Published
2023
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9. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma

Author

Mateos, Maria-Victoria, primary, Rigaudeau, Sophie, additional, Basu, Supratik, additional, Spicka, Ivan, additional, Schots, Rik, additional, Wrobel, Tomasz, additional, Cook, Gordon, additional, Beksac, Meral, additional, Gries, Katharine S, additional, Kudva, Anupa, additional, Tromp, Brenda, additional, Van Rampelbergh, Rian, additional, Pei, Huiling, additional, Wroblewski, Susan, additional, Carson, Robin, additional, Delioukina, Maria, additional, and White, Darrell, additional

Published
2022
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10. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma.

Author

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

Subjects
THERAPEUTIC use of monoclonal antibodies, GENERIC drug substitution, RANDOMIZED controlled trials, RESEARCH funding, DESCRIPTIVE statistics, MULTIPLE myeloma, STATISTICAL sampling, PATIENT safety
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. [ABSTRACT FROM AUTHOR]

Published
2023
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11. sj-docx-1-opp-10.1177_10781552221103551 - Supplemental material for Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma

Author

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

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-1-opp-10.1177_10781552221103551 for Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma by Maria-Victoria Mateos, Sophie Rigaudeau, Supratik Basu, Ivan Spicka, Rik Schots, Tomasz Wrobel, Gordon Cook, Meral Beksac, Katharine S Gries, Anupa Kudva, Brenda Tromp, Rian Van Rampelbergh, Huiling Pei, Susan Wroblewski, Robin Carson, Maria Delioukina and Darrell White in Journal of Oncology Pharmacy Practice

Published
2022
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12. Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone: Update of the Phase 3 MAIA Trial

Author

Perrot, Aurore, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Magaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Liu, Kevin, additional, Fastenau, John, additional, Gries, Katharine S., additional, Ho, Kai Fai, additional, Mistry, Pankaj, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad Z., additional

Published
2021
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13. Efficacy of Daratumumab, Lenalidomide, and Dexamethasone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma and Impaired Renal Function from the Phase 3 Maia Study Based on Lenalidomide Starting Dose

Author

Usmani, Saad Z., primary, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Perrot, Aurore, additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Margaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Pei, Huiling, additional, Van Rampelbergh, Rian, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, and Facon, Thierry, additional

Published
2021
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14. Subcutaneous Daratumumab with Rapid Corticosteroid Tapering in Relapsed or Refractory Multiple Myeloma Patients: Part 3 Update of the Open-Label, Multicenter, Phase 1b Pavo Study

Author

Nahi, Hareth, primary, Usmani, Saad Z., additional, Mateos, Maria-Victoria, additional, van de Donk, Niels W.C.J., additional, Moreau, Philippe, additional, Oriol, Albert, additional, Plesner, Torben, additional, Bandyopadhyay, Nibedita, additional, Hellemans, Peter, additional, Tromp, Brenda, additional, Nnane, Ivo, additional, Zemlickis, Donna, additional, Farnsworth, Andrew, additional, and Chari, Ajai, additional

Published
2021
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15. Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post Hoc Analyses from MAIA

Author

Perrot, Aurore, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Magaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Liu, Kevin, additional, Fastenau, John, additional, Gries, Katharine S., additional, Ho, Kai Fai, additional, Mistry, Pankaj, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad Z., additional

Published
2021
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16. OAB-001: Overall survival and progression-free survival by treatment duration with Daratumumab + Lenalidomide/Dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: phase 3 MAIA study

Author

Moreau, Philippe, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Bahlis, Nizar, additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O’Dwyer, Michael, additional, Perrot, Aurore, additional, Venner, Christopher, additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur, additional, Tiab, Mourad, additional, Macro, Margaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Pei, Huiling, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, and Usmani, Saad Z., additional

Published
2021
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17. MM-155: Phase 3 MAIA Study: Overall Survival (OS) Results with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) vs Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TIE-NDMM)

Author

Orlowski, Robert, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Moreau, Philippe, additional, Bahlis, Nizar, additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O’Dwyer, Michael, additional, Perrot, Aurore, additional, Venner, Christopher, additional, Weisel, Katja, additional, Mace, Joseph, additional, Raje, Noopur, additional, Tiab, Mourad, additional, Macro, Margaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Ahmadi, Tahamtan, additional, Wang, Jianping, additional, Van Rampelbergh, Rian, additional, Uhlar, Clarissa, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad, additional

Published
2021
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18. Poster: MM-155: Phase 3 MAIA Study: Overall Survival (OS) Results with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) vs Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TIE-NDMM)

Author

Orlowski, Robert, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Moreau, Philippe, additional, Bahlis, Nizar, additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O’Dwyer, Michael, additional, Perrot, Aurore, additional, Venner, Christopher, additional, Weisel, Katja, additional, Mace, Joseph, additional, Raje, Noopur, additional, Tiab, Mourad, additional, Macro, Margaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Ahmadi, Tahamtan, additional, Wang, Jianping, additional, Van Rampelbergh, Rian, additional, Uhlar, Clarissa, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad, additional

Published
2021
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20. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis

Author

Kastritis, Efstathios, primary, Palladini, Giovanni, additional, Minnema, Monique C., additional, Wechalekar, Ashutosh D., additional, Jaccard, Arnaud, additional, Lee, Hans C., additional, Sanchorawala, Vaishali, additional, Gibbs, Simon, additional, Mollee, Peter, additional, Venner, Christopher P., additional, Lu, Jin, additional, Schönland, Stefan, additional, Gatt, Moshe E., additional, Suzuki, Kenshi, additional, Kim, Kihyun, additional, Cibeira, M. Teresa, additional, Beksac, Meral, additional, Libby, Edward, additional, Valent, Jason, additional, Hungria, Vania, additional, Wong, Sandy W., additional, Rosenzweig, Michael, additional, Bumma, Naresh, additional, Huart, Antoine, additional, Dimopoulos, Meletios A., additional, Bhutani, Divaya, additional, Waxman, Adam J., additional, Goodman, Stacey A., additional, Zonder, Jeffrey A., additional, Lam, Selay, additional, Song, Kevin, additional, Hansen, Timon, additional, Manier, Salomon, additional, Roeloffzen, Wilfried, additional, Jamroziak, Krzysztof, additional, Kwok, Fiona, additional, Shimazaki, Chihiro, additional, Kim, Jin-Seok, additional, Crusoe, Edvan, additional, Ahmadi, Tahamtan, additional, Tran, NamPhuong, additional, Qin, Xiang, additional, Vasey, Sandra Y., additional, Tromp, Brenda, additional, Schecter, Jordan M., additional, Weiss, Brendan M., additional, Zhuang, Sen H., additional, Vermeulen, Jessica, additional, Merlini, Giampaolo, additional, and Comenzo, Raymond L., additional

Published
2021
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21. Health-Related Quality of Life in Patients with AL Amyloidosis Treated with Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone: Results from the Phase 3 Andromeda Study

Author

Sanchorawala, Vaishali, Palladini, Giovanni, Minnema, Monique C., Jaccard, Arnaud, Lee, Hans C., Gibbs, Simon D., Mollee, Peter, Venner, Christopher P., Lu, Jin, Schönland, Stefan, Gatt, Moshe, Suzuki, Kenshi, Kim, Kihyun, Cibeira, M. Teresa, Beksac, Meral, Libby, Edward, Valent, Jason, Hungria, Vania T.M., Wong, Sandy W., Rosenzweig, Michael, Bumma, Naresh, Chauveau, Dominique, Gries, Katharine S., Fastenau, John, Tran, NamPhuong, Qin, Xiang, Vasey, Sandra Y., Tromp, Brenda, Weiss, Brendan M., Vermeulen, Jessica, Merlini, Giampaolo, Comenzo, Raymond L., Kastritis, Efstathios, and Wechalekar, Ashutosh D.

Published
2020
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22. Reduction in Absolute Involved Free Light Chain and Difference between Involved and Uninvolved Free Light Chain Is Associated with Prolonged Major Organ Deterioration Progression-Free Survival in Patients with Newly Diagnosed AL Amyloidosis Receiving Bortezomib, Cyclophosphamide, and Dexamethasone with or without Daratumumab: Results from Andromeda

Author

Comenzo, Raymond L., Kastritis, Efstathios, Palladini, Giovanni, Minnema, Monique C., Wechalekar, Ashutosh D., Jaccard, Arnaud, Sanchorawala, Vaishali, Lee, Hans C., Gibbs, Simon D., Mollee, Peter, Venner, Christopher P., Lu, Jin, Schönland, Stefan, Gatt, Moshe, Suzuki, Kenshi, Kim, Kihyun, Cibeira, M. Teresa, Beksac, Meral, Libby, Edward, Valent, Jason, Hungria, Vania T.M., Wong, Sandy W., Rosenzweig, Michael, Bumma, Naresh, Chauveau, Dominique, Dimopoulos, Meletios A, Tran, NamPhuong, Qin, Xiang, Vasey, Sandra Y., Tromp, Brenda, Weiss, Brendan M., Vermeulen, Jessica, and Merlini, Giampaolo

Published
2020
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23. Outcomes By Cardiac Stage in Newly Diagnosed AL Amyloidosis: Results from Andromeda

Author

Minnema, Monique C., primary, Dispenzieri, Angela, additional, Merlini, Giampaolo, additional, Comenzo, Raymond L., additional, Kastritis, Efstathios, additional, Wechalekar, Ashutosh D., additional, Grogan, Martha, additional, Witteles, Ronald, additional, Ruberg, Frederick L., additional, Maurer, Mathew S., additional, Tran, NamPhuong, additional, Qin, Xiang, additional, Vasey, Sandra Y., additional, Tromp, Brenda, additional, Weiss, Brendan M., additional, Vermeulen, Jessica, additional, and Jaccard, Arnaud, additional

Published
2020
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24. Subcutaneous Daratumumab (DARA SC) + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd) in Asian Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Subgroup Analysis from the Phase 3 Andromeda Study

Author

Suzuki, Kenshi, primary, Wechalekar, Ashutosh D., additional, Kim, Kihyun, additional, Shimazaki, Chihiro, additional, Kim, Jin Seok, additional, Ikezoe, Takayuki, additional, Min, Chang-Ki, additional, Zhou, Fude, additional, Iida, Shinsuke, additional, Katoh, Nagaaki, additional, Fujisaki, Tomoaki, additional, Shin, Ho-Jin, additional, Tran, NamPhuong, additional, Qin, Xiang, additional, Vasey, Sandra Y., additional, Tromp, Brenda, additional, Weiss, Brendan M., additional, Vermeulen, Jessica, additional, Comenzo, Raymond L., additional, Kastritis, Efstathios, additional, and Lu, Jin, additional

Published
2020
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25. Rapid and Deep Hematologic Responses Are Associated with Improved Major Organ Deterioration Progression-Free Survival in Newly Diagnosed AL Amyloidosis: Results from Andromeda

Author

Wechalekar, Ashutosh D., primary, Palladini, Giovanni, additional, Merlini, Giampaolo, additional, Comenzo, Raymond L., additional, Jaccard, Arnaud, additional, Tran, NamPhuong, additional, Pei, Huiling, additional, Vasey, Sandra Y., additional, Tromp, Brenda, additional, Weiss, Brendan M., additional, Vermeulen, Jessica, additional, and Kastritis, Efstathios, additional

Published
2020
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26. Corticosteriod tapering in patients (Pts) with relapsed or refractory multiple myeloma (RRMM) receiving subcutaneous daratumumab (DARA SC): Part 3 of the open-label, multicenter, phase Ib PAVO Study.

Author

Nahi, Hareth, primary, Usmani, Saad Zafar, additional, Mateos, Maria-Victoria, additional, van de Donk, Niels W.C.J., additional, Moreau, Philippe, additional, Oriol, Albert, additional, Plesner, Torben, additional, Yang, Shiyi, additional, Hellemans, Peter, additional, Tromp, Brenda J., additional, Luo, Man (Melody), additional, Zemlickis, Donna, additional, Farnsworth, Andrew, additional, and Chari, Ajai, additional

Published
2020
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27. Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-Label, Multicenter, Phase 1b Study (PAVO)

Author

Chari, Ajai, primary, Mateos, Maria-Victoria, additional, van de Donk, Niels WCJ, additional, Kaufman, Jonathan L, additional, Moreau, Philippe, additional, Oriol, Albert, additional, Plesner, Torben, additional, Benboubker, Lotfi, additional, Nahi, Hareth, additional, Tang, Jie, additional, Hellemans, Peter, additional, Tromp, Brenda, additional, Clemens, Pamela L, additional, Farnsworth, Andrew, additional, San-Miguel, Jesus F, additional, and Usmani, Saad Z., additional

Published
2018
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28. A phase I/II, multiple-dose, dose-escalation study of siltuximab, an anti-interleukin-6 monoclonal antibody, in patients with advanced solid tumors

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Angevin, Eric, Tabernero, Josep, Elez, Elena, Cohen, Steven J, Bahleda, Rastilav, van Laethem, Jean-Luc, Ottensmeier, Christian, Lopez-Martin, Jose A, Clive, Sally, Joly, Florence, Ray-Coquard, Isabelle, Dirix, Luc, Machiels, Jean-Pascal, Steven, Neil, Reddy, Manjula, Hall, Brett, Puchalski, Thomas A, Bandekar, Rajesh, van de Velde, Helgi, Tromp, Brenda, Vermeulen, Jessica, Kurzrock, Razelle, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Angevin, Eric, Tabernero, Josep, Elez, Elena, Cohen, Steven J, Bahleda, Rastilav, van Laethem, Jean-Luc, Ottensmeier, Christian, Lopez-Martin, Jose A, Clive, Sally, Joly, Florence, Ray-Coquard, Isabelle, Dirix, Luc, Machiels, Jean-Pascal, Steven, Neil, Reddy, Manjula, Hall, Brett, Puchalski, Thomas A, Bandekar, Rajesh, van de Velde, Helgi, Tromp, Brenda, Vermeulen, Jessica, and Kurzrock, Razelle

Abstract

PURPOSE: This phase I/II study evaluated safety, efficacy, and pharmacokinetics of escalating, multiple doses of siltuximab, a chimeric anti-interleukin (IL)-6 monoclonal antibody derived from a new Chinese hamster ovary (CHO) cell line in patients with advanced/refractory solid tumors. EXPERIMENTAL DESIGN: In the phase I dose-escalation cohorts, 20 patients with advanced/refractory solid tumors received siltuximab 2.8 or 5.5 mg/kg every 2 weeks or 11 or 15 mg/kg every 3 weeks intravenously (i.v.). In the phase I expansion (n = 24) and phase II cohorts (n = 40), patients with Kirsten rat sarcoma-2 (KRAS)-mutant tumors, ovarian, pancreatic, or anti-EGF receptor (EGFR) refractory/resistant non-small cell lung cancer (NSCLC), colorectal, or H&N cancer received 15 mg/kg every 3 weeks. The phase II primary efficacy endpoint was complete response, partial response, or stable disease >6 weeks. RESULTS: Eighty-four patients (35 colorectal, 29 ovarian, 9 pancreatic, and 11 other) received a median of three (range, 1-45) cycles. One dose-limiting toxicity occurred at 5.5 mg/kg. Common grade ≥3 adverse events were hepatic function abnormalities (15%), physical health deterioration (12%), and fatigue (11%). Ten percent of patients had siltuximab-related grade ≥3 adverse events. Neutropenia (4%) was the only possibly related adverse event grade ≥3 reported in >1 patient. Serious adverse events were reported in 42%; most were related to underlying disease. The pharmacokinetic profile of CHO-derived siltuximab appears similar to the previous cell line. No objective responses occurred; 5 of 84 patients had stable disease >6 weeks. Hemoglobin increased ≥1.5 g/dL in 33 of 47 patients. At 11 and 15 mg/kg, completely sustained C-reactive protein suppression was observed. CONCLUSIONS: Siltuximab monotherapy appears to be well tolerated but without clinical activity in solid tumors, including ovarian and KRAS-mutant cancers. The recommended phase II doses were 11 and 15 mg/kg every 3 wee

Published
2014

29. A Phase I/II, multiple-dose, dose-escalation study of siltuximab, an anti-interleukin-6 monoclonal antibody, in patients with advanced solid tumors

Author

Angevin, Eric, Tabernero, Josep, Elez, Elena, Cohen, Steven, Bahleda, Rastilav, Van Laethem, Jean-Luc, Ottensmeier, Christian, Lopez-Martin, Jose J.A., Clive, Sally, Joly, Florence, Ray-Coquard, Isabelle, Dirix, Luc Y, Machiels, Jean-Pascal, Steven, Neil, Reddy, Manjula, Hall, Brett, Puchalski, Thomas T.A., Bandekar, Rajesh, Van De Velde, Helgi, Tromp, Brenda, Vermeulen, Jessica, Kurzrock, Razelle, Angevin, Eric, Tabernero, Josep, Elez, Elena, Cohen, Steven, Bahleda, Rastilav, Van Laethem, Jean-Luc, Ottensmeier, Christian, Lopez-Martin, Jose J.A., Clive, Sally, Joly, Florence, Ray-Coquard, Isabelle, Dirix, Luc Y, Machiels, Jean-Pascal, Steven, Neil, Reddy, Manjula, Hall, Brett, Puchalski, Thomas T.A., Bandekar, Rajesh, Van De Velde, Helgi, Tromp, Brenda, Vermeulen, Jessica, and Kurzrock, Razelle

Abstract

Purpose: This phase I/II study evaluated safety, efficacy, and pharmacokinetics of escalating, multiple doses of siltuximab, a chimeric anti-interleukin (IL)-6 monoclonal antibody derived from a new Chinese hamster ovary (CHO) cell line in patients with advanced/refractory solid tumors. Experimental Design: In the phase I dose-escalation cohorts, 20 patients with advanced/refractory solid tumors received siltuximab 2.8 or 5.5 mg/kg every 2 weeks or 11 or 15 mg/kg every 3 weeks intravenously (i.v.). In the phase I expansion (n = 24) and phase II cohorts (n = 40), patients with Kirsten rat sarcoma-2 (KRAS)-mutant tumors, ovarian, pancreatic, or anti-EGF receptor (EGFR) refractory/resistant non-small cell lung cancer (NSCLC), colorectal, or H&N cancer received 15 mg/kg every 3 weeks. The phase II primary efficacy endpoint was complete response, partial response, or stable disease >6 weeks. Results: Eighty-four patients (35 colorectal, 29 ovarian, 9 pancreatic, and 11 other) received a median of three (range, 1-45) cycles. One dose-limiting toxicity occurred at 5.5 mg/kg. Common grade ?3 adverse events were hepatic function abnormalities (15%), physical health deterioration (12%), and fatigue (11%). Ten percent of patients had siltuximab-related grade ?3 adverse events. Neutropenia (4%) was the only possibly related adverse event grade?3 reported in >1 patient. Serious adverse events were reported in 42%; most were related to underlying disease. The pharmacokinetic profile of CHO-derived siltuximab appears similar to the previous cell line. No objective responses occurred; 5 of 84 patients had stable disease >6 weeks. Hemoglobin increased ?1.5 g/dL in 33 of 47 patients. At 11 and 15 mg/kg, completely sustained C-reactive protein suppression was observed. Conclusions: Siltuximab monotherapy appears to be well tolerated but without clinical activity in solid tumors, including ovarian and KRAS-mutant cancers. The recommended phase II doses were 11 and 15 mg/kg every 3 week, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2014

30. A Phase I/II, Multiple-Dose, Dose-Escalation Study of Siltuximab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Author

Angevin, Eric, primary, Tabernero, Josep, additional, Elez, Elena, additional, Cohen, Steven J., additional, Bahleda, Rastilav, additional, van Laethem, Jean-Luc, additional, Ottensmeier, Christian, additional, Lopez-Martin, Jose A., additional, Clive, Sally, additional, Joly, Florence, additional, Ray-Coquard, Isabelle, additional, Dirix, Luc, additional, Machiels, Jean-Pascal, additional, Steven, Neil, additional, Reddy, Manjula, additional, Hall, Brett, additional, Puchalski, Thomas A., additional, Bandekar, Rajesh, additional, van de Velde, Helgi, additional, Tromp, Brenda, additional, Vermeulen, Jessica, additional, and Kurzrock, Razelle, additional

Published
2014
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31. An Open-Label, Phase 2, Multicenter Study Of The Safety Of Long-Term Treatment With Siltuximab (an Anti-Interleukin-6 Monoclonal Antibody) In Patients With Multicentric Castleman’s Disease

Author

Van Rhee, Frits, primary, Casper, Corey, additional, Voorhees, Peter M, additional, Fayad, Luis E, additional, van de Velde, Helgi, additional, Vermeulen, Jessica, additional, Qin, Xiang, additional, Qi, Ming, additional, Tromp, Brenda, additional, and Kurzrock, Razelle, additional

Published
2013
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32. Phase I/II, two-part, open-label, multiple-dose, dose-escalation study of siltuximab in patients with solid tumors.

Author

Angevin, Eric, primary, Elez, Elena, additional, Cohen, Steven J., additional, Van Laethem, Jean-Luc, additional, Ottensmeier, Christian, additional, Joly, Florence, additional, Ray-Coquard, Isabelle, additional, Lopez-Martin, Jose A., additional, Dirix, Luc, additional, Machiels, Jean-Pascal, additional, Clive, Sally, additional, Steven, Neil Matthew, additional, Reddy, Manjula, additional, Hall, Brett, additional, Puchalski, Thomas, additional, Bandekar, Rajesh, additional, Van De Velde, Helgi, additional, Tromp, Brenda J., additional, Vermeulen, Jessica, additional, and Kurzrock, Razelle, additional

Published
2012
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33. Abstract A102: First‐in‐man, first‐in‐class, pharmacokinetic and pharmacodynamic phase I clinical trial of a human monoclonal antibody CNTO888 to CC‐chemokine ligand 2 (CCL2) / monocyte chemoattractant protein (MCP‐1) in patients with advanced solid tumors

Author

Sandhu, Shahneen K., primary, Fong, Peter C., additional, Patnaik, Amita, additional, Papadopoulos, Kyri, additional, Messiou, Christina, additional, Hoare, Susan, additional, Olmos, David, additional, Tromp, Brenda J., additional, Puchalski, Thomas A., additional, Balkwill, Frances, additional, Berns, Birge, additional, Debono, Johann S., additional, and Tolcher, Anthony W., additional

Published
2009
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34. Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post HocAnalyses from MAIA

Author

Perrot, Aurore, Facon, Thierry, Kumar, Shaji, Plesner, Torben, Orlowski, Robert Z., Moreau, Philippe, Bahlis, Nizar J., Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O'Dwyer, Michael E., Venner, Chris P., Weisel, Katja, Mace, Joseph R., Raje, Noopur S., Tiab, Mourad, Macro, Magaret, Frenzel, Laurent, Leleu, Xavier, Liu, Kevin, Fastenau, John, Gries, Katharine S., Ho, Kai Fai, Mistry, Pankaj, Tromp, Brenda, Delioukina, Maria, Vermeulen, Jessica, and Usmani, Saad Z.

Abstract

Introduction:In oncology clinical trials, overall survival (OS) is considered the gold standard efficacy endpoint. However, in multiple myeloma, the prolonged survival times and availability of multiple salvage therapies render it difficult to rely on OS as a primary endpoint. Instead, progression-free survival (PFS) or clinical response can be a relevant biomarker. At the same time, some health technology assessment bodies will only consider evidence based on patient-relevant endpoints, such as morbidity, mortality, and health-related quality of life (HRQoL), within their benefit assessments. Patient-reported outcomes (PROs) provide insights into how a treatment affects HRQoL, including symptoms and functioning. In the phase 3 MAIA trial, daratumumab, lenalidomide, and dexamethasone (D-Rd) demonstrated a significantly prolonged PFS and rapid and sustained improvements in PROs compared with lenalidomide and dexamethasone (Rd) alone at a median follow-up of 28 months. Updated results with longer follow-up confirmed a continued PFS benefit, deepening best clinical responses, and a significant OS benefit with D-Rd. Here, we report the results of analyses exploring the relationship between clinical efficacy endpoints and PROs in the MAIA trial.

Published
2021
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35. Phase 3 MAIA Study: Overall Survival (OS) Results with Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TIE-NDMM)

Author

Orlowski, Robert, Facon, Thierry, Kumar, Shaji, Plesner, Torben, Moreau, Philippe, Bahlis, Nizar, Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O Dwyer, Michael, Perrot, Aurore, Venner, Christopher, Weisel, Katja, Mace, Joseph, Raje, Noopur, Tiab, Mourad, Macro, Margaret, Frenzel, Laurent, Leleu, Xavier, Ahmadi, Tahamtan, Wang, Jianping, Rampelbergh, Rian, Uhlar, Clarissa, Tromp, Brenda, Delioukina, Maria, Vermeulen, Jessica, and Saad Usmani

Subjects
newly diagnosed multiple myeloma, transplant-ineligible, MM, daratumumab

36. Overall survival and progression-free survival by treatment duration with Daratumumab plus Lenalidomide/Dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: phase 3 MAIA study

Author

Moreau, Philippe, Facon, Thierry, Kumar, Shaji, Plesner, Torben, Orlowski, Robert Z., Bahlis, Nizar, Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O Dwyer, Michael, Perrot, Aurore, Venner, Christopher, Weisel, Katja, Mace, Joseph R., Raje, Noopur, Tiab, Mourad, Macro, Margaret, Frenzel, Laurent, Leleu, Xavier, Pei, Huiling, Tromp, Brenda, Delioukina, Maria, and Saad Usmani

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