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Background: Daratumumab showed encouraging efficacy as monotherapy in patients with heavily pretreated multiple myeloma in the GEN501 and SIRIUS studies. Here we report a pooled, post-hoc final analysis of these two studies. Methods: GEN501 was an open-label, multicentre, phase 1-2, dose escalation and expansion study done in the Netherlands, the USA, Sweden, and Denmark.
GEN501 was an open-label, multicentre, phase 1-2, dose escalation and expansion study done in the Netherlands, the USA, Sweden, and Denmark. Eligible patients had multiple myeloma and had relapsed or were refractory to 2 or more previous lines of treatment that included a proteasome inhibitor or an immunomodulatory drug. SIRIUS was an open ...
GEN501 (NCT00574288) was an open-label, multicenter, phase 1/2, dose-escalation and dose-expansion study that included patients with MM who relapsed from or were refractory to ≥2 prior lines of therapy that included a PI and an IMiD. 11 Patients who had an absolute neutrophil count ≥1000/μL, platelet count ≥75 × 10 9 /L, hemoglobin ≥7 ...
The first-in-human clinical study of daratumumab (GEN501) was an open-label, multicenter, two-part, phase 1/2 clinical trial of daratumumab as a single agent in patients with relapsed or relapsed and refractory myeloma evaluating its safety, efficacy, and pharmacokinetics . Thirty two patients were enrolled in part 1 (dose-escalation study ...
daratumumab 16 mg/kg in GEN501 and SIRIUS in a combined analysis, after a median follow-up of approximately 3 years. Methods Study design and participants The study design and patient populations for GEN501 and SIRIUS have been described previously.11-13 GEN501 was an open-label, multicentre, phase 1-2, dose escalation
SUMMARY GEN501 was a phase 1/2 dose-escalation (Part 1) and dose-expansion (Part 2) study primarily assessing the safety of DARZALEX monotherapy in multiple myeloma (MM) patients who had relapsed after or were refractory to ≥2 prior lines of therapy. In Part 2 of the study, the most commonly occurring adverse events (AEs, >25%) were fatigue, allergic rhinitis, pyrexia, diarrhea, upper ...
Methods: GEN501 was a first-in-human, open-label, phase 1/2 study comprising a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). The study enrolled patients with MM that had relapsed after or was refractory to ≥2 prior therapies. In Part 2, patients received an initial infusion of 16 mg/kg DARA, which was followed by a 3 ...
GEN501 was an open-label, multicentre, phase 1-2, dose escalation and expansion study done in the Netherlands, the USA, Sweden, and Denmark. Eligible patients had multiple myeloma and had relapsed or were refractory to 2 or more previous lines of treatment that included a proteasome inhibitor or an immunomodulatory drug.
In GEN501 Part 2, the first 16 mg/kg DARA infusion was followed by a 3 week rest period, and then qw for 7 weeks, q2w for 14 weeks, and q4w thereafter. In Sirius, 16 mg/kg DARA was infused qw for 8 weeks, q2w for 16 weeks, and q4w thereafter. The combined analysis comprised pts treated with 16 mg/kg DARA in Sirius and Part 2 of GEN501.
GEN501 enrolled 104 participants from 2008 and GEN503 enrolled 45 participants from 2012. GEN501 has been completed; GEN503 is active but has finished accrual. We are reporting on ten patients that are still responding to DARA therapy, several years after their inclusion in the GEN501 and GEN503 trials.