Safety evaluation
leuko-, deaths, neutropenia, toxicities
NEUTROPENIA, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, BLOOD AND LYMPHATIC SYSTEM DISORDERS, INFUSION REACTION, EVENTS
The safety results are summarized in Table 
Adverse events (AEs) observed in the patients, graded for relatedness and severity. Light amber shaded lines indicate “possibly related”, light orange “probably related” as rated by the investigator, with related Grade 2 adverse events shown in bold* Indicates 3 identical eventsobserved consecutively in the same person. It needs to be mentioned that thepsychiatric and nervous system-related AEs in this table were observed in onesingle patientThere were no deaths reported in this study. In total 28 AEs were reported, and they were seen in all 7 patients. Eleven out of 28 AEs in total were categorized as ‘not related’ to the study drug, one was rated ‘unlikely related’ while 8 were judged ‘possibly related’ and 7 ‘probably related’. The most frequent AEs fell in the category of blood and lymphatic system disorders, with 9 events recorded in 5 out of 7 patients. In general, no apparent clinically significant changes or abnormalities were observed during the study period, which would have led to termination of the study. No infusion reactions were observed. One patient experienced a neutropenia that was graded of life-threatening severity. This subject had a long-standing fluctuating leuko- and neutropenia, due to impaired bone marrow function as a result of pre-treatment. It was, therefore, judged to be unlikely related to the study drug. The leuko- and neutropenia were not accompanied by clinical symptoms and lasted only one day. Knowing that i.v. administered liposome products tend to be taken up by liver macrophages [No dose-limiting toxicities occurred in both dose levels. There were no serious adverse events (SAEs) and no hospitalizations due to AEs. In the second cohort, one patient suffered from premature progression of disease (development of plasma cell leukemia) and could not be kept in the study cohort until week 8. Therefore, an additional patient was added to this cohort.