Day -3, -2, -1. That's not so much a count down as it is the way my study kicks off. The official start of my 28 day cycle begins tomorrow, Monday, October 13th. However, yesterday was Day-3. On that day I took my first dosage of the drug at 10:30 am after 8:00 am lab tests. Then I was monitored very closely for the next 10 hours until 8:30 pm. So we were at MDA for over 12 hours, yesterday. It was a long, tiring day with hourly lab tests. I was given one dose of the drug, 10 blood draws, 5 EKG's and 3 urinalysis tests.
Yesterday was Day -2. It was a much shorter day with a single blood and urinalysis test at 10:30 am. Likewise, today, Day -1 will be a single testing day at 10:30 am. Then we begin the 1st study day tomorrow morning early at 7:15 am.
Those of us at MDA who were recently added to the study were required to do these days -3, -2, & -1 in order to see how we would react to the drug's toxicity. They also wanted to give us higher doses of the drug to put us at the same dose level as participants who have been in the study, previously. They would have gone through a 28 day cycle at lower levels then moved up to the higher doses like I will be taking. Since we are the first humans to receive this drug, the protocol is very tightly controlled and regulated. Other than for the inconvenience of having to spend so much time at MDA, it was uneventful for me with no side effects.
Over the next 28 days I will take the medicine once a day, mostly from our apartment. Monitoring will be done in the clinic, but on an easier schedule of about once to twice a week. As with my pre-study testing, post study testing will be done with another bone marrow aspiration/biopsy among others. The goal is to see better bone marrow resulting in improved blood counts. Then we see where to go from there.
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