PREPARATION AND EVALUATION OF ULTRASOUND TRANSMISSION GEL

Objective: Formulation of an alternative ultrasound transmission gel that is of good quality using the available chemicals in Iraqi market and without any harmful effects to skin. Methods: Four formulas G1, G2, G3, and G4 with different Carbopol 934 concentrations (0.3, 0.4, 0.5, and 0.6) w/v%, respectively, were prepared and evaluated for different physicochemical characteristics including: Clarity, homogeneity, density, pH, viscosity, and spreadability tests. Other evaluations including skin irritation, microbiological, and stability tests were also performed for the selected formula along with a comparison study with the commercially available ultrasound gel (commercial gel [CG]) which was used as a control. In addition, transmission test was carried out by comparing the transmission between (CG) and (G1) with the assistance of three veterinary radiologists who did ultrasonography of bovine liver for 11 adult cattle breed, aged 3–8 years. The three veterinary radiologists were given 33 data sheets to collect results.Results: Among all the prepared formulas (G1), the formula was considered the best, due to its high clarity, very good homogeneity; its pH was equal to 6.8 which is near to skin pH. Other parameters such as density, viscosity, torque percent, and spreadability showed no significant difference (p≤0.05) with CG. Skin irritation test which was conducted on animals and humans showed no any adverse effects on skin. Microbiological test manifested that using methylparaben alone was sufficient to prevent the growth of microbes in the gel. The three veterinary radiologists found no significant difference (p≤0.05) between G1 and CG formulations. Stability study indicated that the gel was stable after storage at room temperature for 3 months.Conclusion: The overall results suggest that the selected formula (G1) can be considered a successful ultrasound gel and can be used as a good and cheap alternative of the marketed imported gel

Daratumumab Monotherapy for Relapsed or Refractory Multiple Myeloma: Results of an Early Access Treatment Protocol in Europe and Russia

Introduction Daratumumab is a human IgGκ monoclonal antibody targeting CD38. Despite the demonstrated benefit of daratumumab in multiple myeloma, not all patients have access to commercially available daratumumab. Here we report a pooled analysis of patients from the UK, Spain, Italy, and Russia enrolled in an open-label, early access treatment protocol (EAP) that provided daratumumab (16 mg/kg) monotherapy to patients with heavily pre-treated relapsed or refractory multiple myeloma (RRMM). Methods Intravenous daratumumab 16 mg/kg was administered to patients who had received ≥ 3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or who were double refractory to both a PI and an IMiD. Safety and patient-reported outcomes data were collected. Results A total of 293 patients received  ≥ 1 dose of daratumumab. The median duration of daratumumab exposure was 4.2 (range 0.03–24.1) months, with a median number of 13 (range 1–37) infusions. The overall response rate was 33.1%, and the median progression-free survival was 4.63 months. Grade 3/4 treatment-emergent adverse events occurred in 60.1% of patients, of which the most common were thrombocytopenia (18.8%), anemia (11.9%), and neutropenia (11.6%). The most common serious adverse events were pneumonia (4.4%) and pyrexia (4.1%). Infusion-related reactions occurred in 45.1% of patients. The median change from baseline in all domains of patient-reported outcome instruments (European Quality of Life Five Dimensions Questionnaire [EQ-5D–5L], European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ-C30], and EORTC Multiple Myeloma Module [QLQ-MY20]) was generally 0 or close to 0. Conclusion These EAP results are consistent with those from previous trials of daratumumab monotherapy and confirm its safety in patients from Europe and Russia with heavily pre-treated RRMM. Trial Registration ClinicalTrials.gov identifier, NCT02477891