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.

Happy Thanksgiving

Before I talk about our trip to Dana Farber (and the start of Chemo: Round 2), I think it is a good time to stop and think about all we have to be thankful for. Thanksgiving has long been my favorite holiday, since it for most of us it really is the only one that has not been either corrupted by commercialism or ignored as simply another day off from work.

I think that we are living in the best of times in the best of places. In the 100,000 years since the dawn of man and the 10,000 years of recorded civilization, no group of people has ever lived better than we do. In many ways, the average American today lives more comfortably than even most royalty 200 years ago (unless you like fleas, bedbugs disease and other vermin).

And this Thanksgiving I am more thankful than ever for the amazing medical care that is available for most medical problems - including my own. There might not be a total cure for my MM, but there is a good chance for many more good and productive years. More and more, people are "living with cancer" as well as other diseases. And living well with them.

I am particularly thankful today because for the last week, the discomfort from by "strained back" has been getting noticeably better every day. I am still not back to 100% - that will take a while, but it is definitely getting better.

Yesterday, my doctors said I was progressing as expected and that the markers from the various tests indicated that the chemo therapy was working. I made it through the chemo round 1 with minimal adverse side effects. So I am thankful for that.

So. As you sit down for Thanksgiving dinner and spend the weekend with friends and family, don't forget to think about and be especially thankful for all the good health that you have (even if there is some bad health to go along with it).  And also be thankful for the amazing resources that are available to those of us who face diseases. Yes - it might be expensive, but it is better to have it be expensive than to have it not available at all. 

An extra trip to Boston

My first round of chemo was officially completed Tuesday night. Hooray! So far, the side effects have been minimal. Some of my taste buds are a bit numb - others are fine. Makes stuff taste weird, but this is not a big problem. I don't seem to get hungry, but I eat anyway and feel fine afterwards. My lower back still hurts when I stand up or walk around for too long, but that is not a side effect - it is one of the things they are trying to fix. It is a little better this week than it was last week.

So, we were supposed to have a week off from driving to Boston. Except that Tuesday afternoon, we got a call from the cancer docs regarding the sodium thing. They came up with a theory that it was caused by pseudohyponatremia (easy for you to say). What they are saying is that my sodium levels might be OK, but that other crap in my blood (from the cancer) is messing up the readings. They wanted me to see a doctor who specializes in nephrology for people with blood cancers,. Now, this is getting pretty specialized if you ask me, but I guess you want specialists.

Which meant that Barbara and I got to hop into the car again yesterday morning and make another schlep to Boston. We met with the doctor and chatted for 15 minutes. He sent us down to the labs for more blood samples (big surprise there, right?) and then sent us home. He said that he should get results on Friday.

If it turns out that the low sodium readings are due to pseudohyponatremia (don't you just love that word), it will probably mean that I can get the Velcade infusions, even if the readings are too low. It does worry me a bit that my blood is in such rough shape that the machines can't deal with it, but I will worry about that later.

So, for now, I am sitting hear, relaxing and waiting for my medical insurance broker to show up to help me register for a new insurance plan for next year. (If you like your insurance plan you can keep it. . . ) Well - mine is one that is going away after next year. So, I am switching over to another plan with a much lower deductible which should save me a fair bit of money. 

Infusion Success

You may recall that at the end of our last exciting episode (on Wednesday), I had been unable to get my Velcade infusion due to my sodium levels being too low. We had similar problems today, but managed to work through them.

Last night, I tried increasing my salt intake and reducing my water intake in an attempt to raise sodium. I was actually taking salt tablets. However, when they tested me today, they found the same low sodium levels that they had seen on Wednesday.

I had brought a bunch of salty snacks and upon getting this news, I tore open and ate and entire large bag of White Cheddar Cheese Popcorn - the saltiest snack I had. I also took a couple of salt tablets and drank the rest of my V-8. After a half hour, they drew another sample and found this on to be 129. Progress but still not high enough.

The test had taken an hour or so and I suggested that some additional salt from the popcorn might have been absorbed and that they try again. We figured that this would be a real long-shot, but it was worth a try. And guess what? It worked. Hooray!

So, they gave me the infusion and sent me home. It is true that the dose they gave me was slightly reduced, but I was very happy to get anything. You can imaging that the thought of missing a second treatment was a bit depressing, but Barbara and I were both thrilled with even the slightly reduced amount.

So, we had a successful day and all is well. 

Help! I'm talking and I can't shut up!

As you all know, I am right in the middle of my first chemo sequence. I am sure you have all heard about the horrors of chemotherapy, with the nausea and baldness, etc.. But it turns out that there are is chemo therapy that is not so bad and that is what I am getting. So far, I have had only very minor side effects.

One side effect that they warned me (or more accurately that they warned Barbara about) is that they said I might develop a tendency to talk more than usual. Yup - they said I might become a real "motor mouth". Imagine me talking more than usual. A frightening thought. I mean, really, how can someone talk more than "constantly". But it happens from time to time. When it does occur, it is as if my mouth can't keep up with my brain and I end up thinking a sentence ahead of where my mouth is. It is actually kind of weird from my perspective. I can only imagine how it is for Barbara.

But that would not be so bad if it were not for the other side effect. I have a propensity to get hiccups. The seem to start for no reason at all. So, not only is my mouth going a mile a minute, but I am hiccuping at the same time.

Now add to that the Oxycodone meds which may have a tendency to scramble my brain a bit.

Maybe I should have skipped the Zoning Board Meeting last night. You may be aware that I sit as a member of the Town of Meredith Zoning Board of Adjustment - the key word being "sit" which is no problem for me. I am not normally one of the more quiet members and let's just say that last night was no exception. Fortunately, I was mostly able to suppress the hiccups during the times I was actually speaking.

So, now we are getting ready for tomorrow's trip to Boston - hopefully for my chemo infusion. I will be working to get my salt levels up and let me tell you that I am making the absolute best of it. I went to the supermarket this morning and decided to purchase a bag of Cape Code Potato Chips. I chose the high fat variety - because it had more salt. I also found some cheese twirls  that had even more salt than the chips and then I found some cheese popcorn that has even more salt than the cheese twirls. I'm ready. 

Skipped Chemo Treatment

Barbara and I drove to Dana Farber yesterday in anticipation of my third chemo infusion. Unfortunately, I never got it. Before the infusion, they check a whole bunch of blood indicators and it turns out that my sodium level was 128 where they demand a minimum of 130. They gave me a bag of potato chips, some salty crackers and a bottle of V-8 (known to be salty) and tested me again. Same thing. We ended up sitting there for 5 hours and then they sent us away, deciding to treat this as a missed dosage. They did not seem to think this was a big deal, but they are not the ones with the disease.

The part that bothers me most is that this treatment is supposed to be part of a clinical trial. It is because it is a clinical trial that they insisted on the minimum sodium threshold. If I had not been on the clinical trial, they said they would have given me the chemo treatment anyway. This makes me wonder if the clinical trial details are more important than treatment.

So, I guess we will see what happens on Saturday when my next infusion is scheduled. We have purchased a six-pack of V-8 for me to drink on the way down to DF and I am thinking of picking up a package of Cape Cod Potato Chips to snack on while they are taking the blood sample.

Other than that, things are pretty good. By deviating slightly from my recommended pain meds, I have managed to find a combination that makes me feel pretty good and be pretty lively. Of course, tomorrow, they want me to try yet another scheme which I will do; hopefully, it will work as well or better.

Last night, after getting bounced from DF, we drove to have dinner with friends Patsy, Jim and Anita. We had a lovely dinner and evening. I could not drink wine, but I found that oxycodone is an acceptable substitute. 

Chemo has started

Barbara and I are now in Boston at a really nice B&B near Dana Farber. Chemo officially started yesterday. So far, it has been quite painless and uneventful. It consists of two kinds of pills most days and an "infusion" twice a week. We decided to stay here in case there were any problems with any of the chemo drugs, which so far there have not been. I still feel fine - or at least no worse - probably slightly better because of all the steroids.

There is one potential side effect which has Barbara rather worried. They tell me that I might start talking much more than normal. I agree that this could be a frightening prospect.

Lots of pills. Perhaps if the motor-mouth effect extends to my blogging, I will have more to day about the pill thing over the next few days.

We will be here until the second infusion on Saturday after which time we will be heading back to NH to see our cats.

Regarding, these blogs, people should not expect them to be frequent or even regular. I intend to update them as I feel that I have something interesting to report - or possibly as I think of an entertaining thought or perspective to mention. This is why signing up for auto notification might be a good idea.