scholarly journals Comment on a paper by Dupoiron et al. “A phase III randomized controlled study on the efficacy and improved bowel function of prolonged-release (PR) oxycodone- naloxone (up to 160/80 mg daily) versus oxycodone PR”

2017 ◽  
Vol 21 (10) ◽  
pp. 1772-1773
Author(s):  
Joanne Patel ◽  
Jennifer H. Martin ◽  
Catherine J. Lucas
Keyword(s):  
Bowel Function ◽  
Phase Iii ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Prolonged Release ◽  
Randomized Controlled

Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study.

2016 ◽  
Vol 34 (18_suppl) ◽  
pp. LBA4-LBA4 ◽  
Author(s):  
Antonio Palumbo ◽  
Asher Alban Akmal Chanan-Khan ◽  
Katja Weisel ◽  
Ajay K. Nooka ◽  
Tamas Masszi ◽  
...  
Keyword(s):  
Safety Profile ◽  
Sensory Neuropathy ◽  
Standard Of Care ◽  
Phase Iii ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Prior Therapy ◽  
Randomized Controlled ◽  
Grade 3 ◽  
Line Of Therapy

LBA4 Background: Daratumumab (D), a human anti-CD38 IgGκ mAb, induces deep and durable responses with a favorable safety profile in RRMM pts. We report a pre-specified interim analysis of the first randomized controlled study of D (CASTOR; NCT02136134). Methods: Pts with ≥1 prior line of therapy were randomized (1:1) to 8 cycles (q3w) of bortezomib (V)/dexamethasone (d) (V: 1.3 mg/m2sc on Days 1, 4, 8, 11; d: 20 mg po on Days 1, 2, 4, 5, 8, 9, 11, 12) ± D (16 mg/kg iv qw in Cycles 1-3, Day 1 of Cycles 4-8, then q4w until progression). Primary endpoint was PFS. Results: 498 pts (DVd, 251; Vd, 247) were randomized. Baseline demographics and disease characteristics were well balanced. Pts received a median of 2 prior lines of therapy (range 1-10). 66% received prior V; 76% received prior IMiD; 48% received prior PI and IMiD; 33% were IMiD-refractory; 32% were refractory to last line of prior therapy. With median follow-up of 7.4 months, D significantly improved median PFS (61% reduction in risk of progression) and TTP for DVd vs Vd (Table). D significantly increased ORR (83% vs 63%, P <0.0001), and doubled rates of ≥VGPR (59% vs 29%, P <0.0001), and ≥CR (19% vs 9%, P= 0.0012) for DVd vs Vd, respectively; median duration of response was NR vs 7.9 months, respectively. Most common (>25%) AEs (DVd/Vd) were thrombocytopenia (59%/44%), peripheral sensory neuropathy (47%/ 38%), diarrhea (32%/22%) and anemia (26%/31%). Most common grade 3/4 AEs (>10%) were thrombocytopenia (45%/33%), anemia (14%/16%), neutropenia (13%/4%). 7%/9% of pts discontinued due to a TEAE. D-associated infusion-related reactions (45% of pts) mostly occurred during the first infusion; most were grade 1/2 (grade 3/4, 9%/0%). Conclusions: D significantly improved PFS, TTP, and ORR in combination with Vd vs Vd alone. DVd doubled both VGPR and sCR/CR rates vs Vd alone. Safety of DVd is consistent with the known safety profile of D and Vd. The addition of D to Vd should be considered a new standard of care for RRMM pts currently receiving Vd alone. Clinical trial information: NCT02136134. [Table: see text]

scholarly journals Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study

2016 ◽  
Vol 12 (12) ◽  
pp. 3072-3078 ◽  
Author(s):  
Stephanie Pepin ◽  
Henryk Szymanski ◽  
Ilya Angélica Rochín Kobashi ◽  
Sandra Villagomez Martinez ◽  
José Francisco González Zamora ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Phase Iii ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Quadrivalent Influenza Vaccine
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