Sunday, December 1, 2013

Clinical Trial

At least one reader has asked me for more details regarding the "Clinical Trial" in which I am participating. It is not really all that complicated, so I will try to explain what is going on - first by describing the current "Standard of Care" and then noting how the clinical trial differs from it - not much as you will see.

The "Standard of Care" is what pretty much everyone with MM get for treatment - or at least it is the target of what people should get. My understanding is that it is the role of the oncologist to monitor progress and possibly tune the treatment depending upon how people respond - both in terms of disease control and side effects. The "Standard of Care" has the following components:

  • The foundation and apparently most important component is something called "RVD Therapy" which stands for Revlimid-Velcade-Dexamethazone. To make this more interesting, they are actually giving me Lenalidomide/Bortezomib/Dexamethazone - which they assure me is the same thing. One cycle of treatment takes three weeks with days numbered from 1 to 21. During the cycle, I take the Dex during days 1-14. I take Revlimid on days 1,2,4,5,8,9,11 &12. These two are pills that I take at home. The Velcade goes in via IV (infusion) on days 1,4,8 and 11. For the infusion, we drive to Boston (2-3 hours each way) for a blood test and the infusion. The infusion takes 10 seconds. This is 5 hours of driving for 10 seconds of treatment. Then days 15 to 21 are rest days. In addition to the RVD therapy, I also take a series of a half dozen vitamin supplements (except no vitamins on Velcade days) plus oxycontin for my back pain plus Colace and ducolax for the constipation caused by the oxycontin plus sometimes a couple of other more optional pills.  I have a 21 day spreadsheet / checklist to help with this. Anyway, this RVD therapy is the core of my treatment. There are a whole list of potential side effects, but so far for me at least, these have been pretty minor. 
  • Component #2 is Stem Cell Harvest. For this, they inject me with a rather hefty dose of some other chemo treatment followed by having me give myself shots every day for a couple of weeks. The goal here is to get my body to produce stem cells and then to release them so that they can be harvested at the end of a couple weeks of treatment. This promises to offer more in the way of side effects - from possible nausea to hair loss - not that I have all that much left to lose at this point in my life. But still, this should not be too bad. 
  • Component #3 is is the Autologous Stem Cell transplant. For this, they put you in the hospital while they essentially wipe out all your bone marrow - or at least a certain part of your bone marrow. They then inject you with the harvested stem cells - or actually half of them saving the other half for possible later use. The idea is that these stem cells will take root in your system and replace the bone marrow that was wiped out. During this three weeks, you have essentially no immune system, so they keep you pretty much isolated in the hospital for the three weeks. Apparently, this is the toughest of the therapies. 
So those are the three components no matter whether one is on the clinical trial or not. If you are not on the clinical trial, you get 3 to 6 RVD cycles (normally 3 or 4) followed by stem cell harvest followed by stem cell transplant. 

The clinical trial  has two "Arms" - named Arm A and Arm B. Arm B is very close to the standard of care. Arm B people get 3 cycles of RVD followed by stem cell harvest followed by stem cell transplant followed by two more RVD cycles followed by maintenance doses of Lenalidomide until disease progression.

I have been assigned to Arm A. I get three cycles of RVD followed by stem cell harvest followed by 5 more cycles of RVD followed by maintenance doses of Lenalidomide until disease progression. Note that there is no stem cell transplant on this arm. 

At this point, the clinical trial is over. Apparently, the goal is to see if the RVD treatment without the stem cell transplant holds off disease progression as long as the stem cell transplant treatment. It seems that the transplant itself is the least fun of all the treatments not to mention the expense of three weeks in the hospital. 

I was hoping to be assigned to Arm A - which in fact I have been. You may note that the stem cell transplant is not part of my treatment according to the clinical trial. But when the disease progresses (hopefully years from now), even though I am then off the trial, I can then get the stem cell transplant. To my logical, but medically untrained engineering brain, it seems that the Stem Cell Transplant is sort of like hitting the Reset button. It wipes out your bone marrow and then starts over - with hopefully better bone marrow - that has just been through chemo. I figure that it is better to delay the reset as long as possible. But what do I know.

The oncologists said they thought this was the better track, but when I asked them if they told the "Track B" patients that "Track B" was better, they laughed and refused to answer. But I really do think they are hoping for better results from "Track A". My understanding is that it is very difficult for doctors to avoid influencing outcomes of these clinical trials and I want to be on the side that the doctors are rooting for. . .

So that is the description of the clinical trial. Let me know if you have any questions - either by entering a comment onto the blog or sending me an email directly.

Along with my assignment to Arm A, they also gave me a schedule for my treatment over the next several months. Since this entry is already pretty long, I will save the schedule for another blog entry. Is this the "hook" to get you to read the next blog posting (episode)? If so, it occurs to me that it is a pretty weak hook.

No comments:

Post a Comment