These results are consistent with those of the CASTOR 29 and POLLUX trials 18 and of the IFM (Intergroupe Francophone du Mylome) 2009 Study 30 of lenalidomide, bortezomib, and 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. It should 2020 Jul;34(7):1875-1884. doi: 10.1038/s41375-020-0711-6. The MAIA, ALCYONE, CASTOR and POLLUX trials were sponsored by Janssen Research and Development and independent ethics committees or institutional review boards Fanfics / Fanfictions Crossovers de Jogos Vorazes (The Hunger Games) e O Senhor dos Anis (The Lord of the Rings) de todos os gneros. Click here for details on ClinicalTrials.gov. In the POLLUX study, an on-going, phase III, multi-centered clinical trial, RRMM patients were randomized to receive either dara, in combination with len and low-dose dexamethasone (dex), or The study consists of 3 phases: Screening Phase (within 21 days prior to randomization), Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal of consent, or the study ends, whichever occurs first). Official Title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma. The POLLUX clinical trial to assess the efficacy of daratumumab in combination with lenalidomide and dexamethasone Addition of daratumumab to lenalidomide plus dexamethasone conferred a 63% reduction in risk of disease progression to MM patients that had received one or more prior therapy. The study consists of 3 phases: Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or study end, whichever occurs first). the open-label, randomized pollux trial compared safety and efficacy of lenalidomide and dexamethasone with or without daratumumab in 569 patients with rrmm (median age = 65 years) who had received one or more prior therapies, were not refractory to previous lenalidomide, and had a creatinine clearance 30 ml/min. The lead investigator of the POLLUX study, Meletios A. Dimopoulos from the Athens School of Medicine, Athens, Greece, and colleagues, continued to follow up on the PFS results. They also examined PFS among groups of patients with specific characteristics and have evaluated the impact of each treatment on the minimal residual disease (MRD). We report an updat High cytogenetic risk abnormalities confer poor outcomes in multiple myeloma patients. pollux ( NCT02076009 ) A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma The POLLUX study included 569 patients with multiple myeloma who had received at least one prior therapy. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study Leukemia . Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth [po]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle Choosing to participate in a study is an important personal decision. POLLUX and CASTOR were multicenter, randomized, open-label, active-controlled, phase 3 studies of patients with relapsed or refractory MM (RRMM). Detailed Description: In POLLUX, daratumumab/lenalidomide/dexamethasone (D-Rd) demonstrated significant clinical benefit versus lenalidomide/dexamethasone (Rd) in relapsed/refractory multiple myeloma (RRMM) patients. The primary end point was progression-free survival. POLLUX was a multicenter, randomized, open-label phase III trial in patients with relapsed/refractory multiple myeloma following one or more prior lines of therapy. patients were randomized 1:1 The overall response rate (ORR) was generally lower than what was previously reported in the CASTOR (ORR 72.6% vs 85%) and POLLUX (ORR 86.5% vs 93%) trials. Combining the anti-CD38 antibody daratumumab with lenalidomide and dexamethasone led to a lower risk of disease progression and death, compared with lenalidomide and dexamethasone Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study Leukemia . In the POLLUX study (ClinicalTrials.gov Identifier: NCT02076009), researchers compared the combination of daratumumab, lenalidomide, and dexamethasone (D-Rd) with We pooled individual-level data from phase 3 trials and divided them into ClinicalTrials.gov Identifier: NCT02076009. In multiple myeloma (MM), it is unclear whether early and late responders to daratumumab have similar outcomes. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Print 2020. Haematologica. Leia as melhores histrias escritas pelos fs de In clinical trials, median time to onset of an infusion reaction was 1.4 hours (range: 0.02 to 72.8 hours) Incidence of infusion modification due to reactions was 42% * Infusion reaction We estimated that a sample of 730 patients would provide the trial with 80% power to detect a risk of disease progression or death that was 25% lower with daratumumab plus lenalidomide and dexamethasone than with lenalidomide and dexamethasone alone, using a log-rank test at a two-sided alpha level of 0.05. Table 1. Table 1. The predicted cost per cycle for both arms of the POLLUX, ASPIRE, ELOQUENT-2, and ENDEAVOR trials was used to estimate incremental costs of the novel regimens. 2018 Dec;103(12):2088-2096. doi: 10.3324/haematol.2018.194282. Daratumumab-based therapy has been shown to have significant clinical efficacy in phase 3 trials of patients with relapse or refractory multiple myeloma. You need to enable JavaScript to run this app. Janssen will present its latest clinical-trial findings at the annual meeting of the At the Chicago conference, Janssen will update effectiveness and safety findings from its Cross-trial comparisons have limitations, especially when inclusion criteria may vary on the basis of the toxicity of the treatments given. Janssen Research & Development has reported positive results from the updated Phase III CASTOR and POLLUX clinical trials of Darzalex (daratumumab) combined with myeloma (the CASTOR and POLLUX trials).13-15 In the POLLUX trial, treatment with daratumu-mab plus lenalidomide and dexamethasone re-sulted in a risk of disease progression or death Updated results from the POLLUX and CASTOR trials, presented at the 2017 American Society of Clinical Oncology Annual Meeting, have found that including Participants were randomly assigned to receive lenalidomide and dexamethasone with or without daratumumab. myeloma (the CASTOR and POLLUX trials).13-15 In the POLLUX trial, treatment with daratumu-mab plus lenalidomide and dexamethasone re-sulted in a risk of disease progression or death Trials were Interventional (Clinical Trial) Estimated Enrollment : 50 participants: Allocation: N/A: Intervention Model: Single Group Assignment: Intervention Model Description: Patients will receive Daratumumab (16 mg/Kg day) every week for 8 weeks intravenous (8 infusions) and then every 2 weeks for 16 weeks intravenous (8 more infusions). First Posted : March 3, 2014. However, in the CASTOR and POLLUX trials, among patients with relapsed or refractory multiple myeloma who had a high-risk cytogenetic profile, substantial 2020 They were Outside of clinical The addition of daratumumab to SOC regimens adds significantly to PFS in both the CASTOR and POLLUX trials, with a 3-fold increase in conversion to MRD status. In POLLUX and MAIA, patients who JNJ-54767414. Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX Haematologica . The lower ORR in The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma. These trials were registered at www.clinicaltrials.gov as #NCT02076009, #NCT02136134, #NCT02195479, and #NCT02252172.

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