Today we left at 6:00 am for our 7:45 appointment at DFCI. This marked the tenth and last visit during Cycle 1 of my treatment protocol. I received the last dose of the steroid dex for the month (I can't wait to see what other projects I can finish this week), and I'm off all the meds now until next Tuesday, which begins Cycle 2.
We were somewhat alarmed at my blood test results this morning. Most of my blood cell counts (WBC, RBC, Hemoglobin, Hematocrit, Neutrophils) were distinctly lower than last week, while my monocytes were way higher, all out of normal range (gulp). Fortunately, we then met with Kathy Colson, the RN who heads up this Clinical Trial, and she said everything was fine (whew). She said these results were expected as part of the treatment, which is why they stop giving the MLN and Revlimid for the latter part of each cycle, allowing the body to recover before the next cycle. I guess that makes sense. I suppose if the drugs are lambasting the shit out of the bad blood cells, they probably take out some of good ones as well. Using Dr. Richardson's military metaphor, I guess we can call that collateral damage.
We also learned more today about how this Phase I Clinical Trial is proceeding. Phase I trials involve a small number of patients (normally a dozen or so) to establish the safety of the experimental drug. In Phase I, dose escalation studies are performed to determine the Maximum Tolerated Dose (MTD) of the drug that doesn't cause toxic side effects. This MLN9708 clinical trial now includes about 13 patients nationwide. Before I joined last month, they had just tentatively established this MTD level, based on the previous patients' responses. I have been taking this provisional MTD level so far this month without any noticeable side effects. Actually, I'm feeling great! To tell the truth, if I didn't know about this diagnosis, I wouldn't think that there is anything wrong with me.
As it turns out, I am part of a sample group of three trial patients across the country who are testing this provisional MTD dose level during this month. If all three of us show no bad side effects (count me in), they will consider Phase I complete and immediately transition this Clinical Trial into Phase II, where they may extend this treatment protocol to many hundreds of people. I can't tell you how fortunate I feel to have gotten in on the ground floor of this trial. It couldn't have come at a more propitious time for me. I am one lucky duck!
Kathy confirmed that the three other trial participants at DFCI are continuing to respond very well to this protocol. She is extremely enthusiastic about how this is going so far. Next week, we meet with Dr. Richardson. I don't know how much information he will have by then about my response to date, but we're keeping our fingers crossed.