Wednesday, April 22, 2015

Day One of Cycle One

I'm now on a study of a new drug (Primary drug), along with dexamethasone (Dex).  I take both once per week for three weeks, then one week off from the Primary drug, then repeat that cycle.

Yesterday was Day One.  We drove 100 miles to Mayo Clinic in Rochester for no reason other than to pick up the pills of the Primary drug (they wouldn't Fedex them), then waited 3 1/2 hours to pick them up, which normally takes less than an hour (not Mayo Clinic's best day, grump grump).  But we got back by dinner time, to take them as follows:
  • Dex with the evening meal: ten tiny 4-mg tablets = 40 mg.
  • Wait an hour and a half after finishing the meal and my one beer.  I asked - the pharmacist said beer is food.  Tsk.
  • Take a Kytril tablet (Granisetron) against possible nausea.
  • Wait another half hour.
  • Take the Primary drug.
This study has two arms which vary in the amount of the Primary drug. Apparently I'm in the high-maintenance arm, more likely to have side effects I'm thinking, but possibly more effective as well.  OK with me, because they'll drop the dosage if I run into trouble.  I want to see that PET Scan spot (lesion) on my T5 vertebra go away.

So far, on day 2, also known as the morning after, NO Problems:
  • My biggest concern is neuropathy, but after just one day I certainly wouldn't expect any neuropathy, and there is none.  I have just a little neuropathy anyway in fingers and feet, and that actually seems to be less today.  Perhaps the Dex is improving it temporarily - Dex is a powerful anti-inflammatory among other things.  Seven years ago the Dex with a different regimen cured my chronic headaches, apparently for good.
  • I experienced no nausea.  The prescription suggests taking one pill just before taking the Primary drug, then another 12 hours later.  I skipped the second one.
  • I slept well, despite the drugs.  Dex, especially, makes that difficult for some people - I'm lucky.
  • My blood oximeter displayed 97% with a heart rate of 55, both this morning and this evening.  Prior to this therapy, for the last seven years, those numbers would usually be about 98% and 44.  Heart rate is low because I'm a runner, with stronger than usual "cardiopulmonary function," according to the docs.  We'll see what they are during the week, off Dex.
  • In addition to neuropathy, the drugs can cause a drop in platelets and neutrophils, among others.  For this first month I will get weekly CBC counts.
I felt WONDERFUL in my run this morning, and ran faster than usual, an effect of the Dex.  It's like waaaay too much coffee.  I've had Dex before, and if experience teaches anything I won't feel quite so wonderful tomorrow, as the Dex effect wears off.  I'll let you know.

Monday, April 13, 2015

New Regimen

After seven years my myeloma has finally made an end run around my dear friend Pomalyst and found a way to hurt me.  The previous post shows the PET scan of the hot little lesion that threatens to hurt my spine.  Pomalyst is still working, you might say, because the blood markers IgG and M-Spike continue to be stable.  Nevertheless the T5 lesion appeared, so something must change soon, and I am enrolling in a study of a new drug.

Enrollment in the study is tomorrow, Tuesday, with a battery of appointments:
  1. Urine test
  2. Doctor visit
  3. Bone marrow biopsy
  4. Electrocardiogram
  5. Chest X-Ray
  6. Blood draw for who knows what
  7. Skeletal bone survey
  8. Second doctor visit
  9. 30-minute study (don't know what this is - maybe the pill pickup?)
This basically takes all day, but I'm very happy that they made it all fit into one day because it's nearly a 2-hour drive for us each way.

I consider myself an exceedingly lucky myelomiac, because once again the myeloma menace was discovered before it really hurt me.  There was no way to find this nasty little hot spot except a PET scan, and those are not performed routinely.  Had the scan not been done, most likely I would eventually have broken that vertebra, requiring surgery and possibly resulting in serious permanent injury.  Lucky.
  
Patient advocacy did play a part in the luck, though.  For seven years, on the anniversary of my start in the Pomalyst trial, I have requested some sort of check on the bones, be it an X-Ray survey, a DEXA scan, or a PET scan.  This year the PET seemed appropriate because of a minor pain in the lower back.  Nothing was found down there, but the T5 lesion up by the heart changed everything.

A fond farewall to Pomalyst, which has protected me through 60 marathons, including one in each of 47 states.  We were hoping to get to 50 states on Pomalyst this year, needing only Wisconsin, Illinois, and Nevada, but that will have to wait.  Anyway 47 isn't bad.  Perhaps we'll see Pomalyst again some time, probably in combination with something equally effective.  Meanwhile we keep running.

Friday, April 10, 2015

Seven Great Years

I started on a trial of Pomalyst seven years ago, 92 cycles ago, starting with CC-4047 (now Pomalyst) and dexamethasone (DEX) but most of the time taking 2 mg of Pomalyst daily as a single agent.  It's still keeping the M-Spike down to 1.1, but a PET scan on Tuesday revealed a small but bright (very active) myeloma lesion in the T5 vertebra.  This means that the current regimen is no longer working, my spine is at risk, and something has to change.

Copyright (c) 2015 Mayo Clinic
The image shows a cross-section of my body laying on my back, the view slicing through both arms and the chest, including the lungs (black) and with the T5 vertebra at the bottom.  The brightest spot is the myeloma, just above the spinal cord in the vertebra.

This image is copyrighted 2015 - no one has permission to display it online or anywhere else.

Dr L called this evening and we had a wonderful conversation.  Some points:
  • This may mean that the myeloma has mutated in that location, or that a pre-existing clone, resistant to Pomalyst, has finally raised its ugly head there.
  • Either way, this lesion has to be treated, both to protect the spine and to keep the new clone from taking over.
  • There is no way to know how fast the lesion is growing, so sooner is better than later.
  • The lesion is not accessible by needle (for a biopsy or for treatment), because the lungs and aorta are in the way from the front and side, and the spinal nerve bundle and bone prevent access from the back.
  • Dr L didn't think it was a good target for radiation therapy, feeling that a systemic treatment should be tried first.
  • This lesion probably cannot be seen by x-ray.  The hole in the bone might be seen by CT-scan, but that wouldn't show whether the myeloma was still active, so the only way to confirm a successful treatment will be another PET scan showing that the sugar-sucking bright spot is gone.
Here are three interesting treatment possibilities:
  • The study started with Pomalyst and dexamethasone, so why not just add DEX back to the regimen?  This would be the most conservative approach, but I'm not enthusiastic about it because I think the bright little lesion needs more aggressive treatment.  I really really want to stomp it out.  Really.
  • How about adding a few cycles of Kyprolis to the Pomalyst (with DEX), and then going back to Pomalyst maintenance if that regimen succeeds?  This approach might work, as Kyprolis and Pomalyst are a very potent combination.
  • There is a study of Ixazomib (MLN9708) with DEX at Mayo Clinic.  Ixazomib is a new oral proteasome inhibitor which appears to be very active against myeloma with few side effects.  The study regimen includes DEX, but not Pomalyst.  Mayo is checking to see if I am eligible.
There are other choices, of course, several others.  We exclaimed about the abundance of therapies available now, compared with those available 12 years ago when I was diagnosed.  Even thalidomide was then available only in a trial, and there was no Pomalyst, Revlimid, Velcade, Kyprolis, or (several others).

How to choose?  My personal goal is to stay alive and competent for as long as I can benefit my wife and daughter.  I believe that's my purpose here on earth, so all medical decisions are made with the advice of a great doctor and with that goal in mind.

Sunday, April 5, 2015

Dr Martha Q Lacy, Woman of the Year


The Leukemia & Lymphoma Society (LLS) combats all blood cancers, including myeloma, supporting research as well as the patients themselves.  Every year the LLS holds a Woman (and Man) Of The Year competition, to raise funds and to honor the nominees.  Dr Lacy is a nominee this year.
Martha Q Lacy, M.D.

Dr Lacy has been my doctor for the last seven of my 12 years with myeloma.  She introduced me to a trial of Pomalyst, the drug that has kept me up and literally running for all of those seven years.  More importantly, she is the Chair of the Division of Hematology at Mayo Clinic, a Professor of Medicine, a frequent speaker at conferences of the American Society of Hematology, and doctor for hundreds of other myeloma patients.  She's the real deal.

Recommended reading:  Here is a copy of a letter that we received from her a few days ago: lacyletter.html.

If you would like to honor Dr Lacy in the LLS competition, and help all of us blood cancer patients to boot, please go to her secure fundraising web page.

Thank you!

Don

Wednesday, March 11, 2015

Kit Draw

That's what they call it.  For the first time in 92 cycles of Pomalyst, we three did not drive the 200-mile round trip from home to Mayo Clinic and back.  Instead we agreed with Mayo that the blood draw could be done at a local clinic.  Mayo, however, still wanted to use their own lab for the critical measurements of IgG, M-spike, and maybe some others.  This is how it worked:
  • A couple of weeks ago Mayo sent me a cube-shaped box (kit), perhaps 10 inches on all sides, containing five vials, instructions, a FedEx overnight return label, and a freezable gel block about the size of a pound of hamburger.  Instructions said to do the draw on March 9.  
  • Just to check, I stopped in at the clinic a week or so ago, showed them the box, and asked about the kit draw.  "Oh yeah, we do that all the time," was the response.  
  • I froze the gel.  
  • On March 9, Monday afternoon (fasting!), I put the gel back in the box and took the whole box to the local clinic.  The two people at the lab desk were unfamiliar with the process but they read the instructions and were game to do it, if I would stick around for an hour or two and carry the completed kit to the FedEx office a half mile away.  It might take that long because the instructions required them to centrifuge a couple of the samples.
  • While I waited, though, we encountered a more seasoned technician who had indeed done this before, and who informed us all that the clinic has a regular, scheduled FedEx pickup every afternoon.  So I left it all in their good hands.  
  • By Tuesday afternoon the results were available for my viewing in my Mayo Clinic account, looking very much like my usual results.
In particular IgG was down slightly, from 1270 to 1210 mg/dL, and M-spike from 1.2 to 1.1 g/dL.  Down is better than up, but I'm thinking that both of those changes are probably within the margin of error for their tests, so the differences are not significant.  Stable = boring = wonderful.  Life is good.  I feel like going out for a run.

Tuesday, February 24, 2015

FDA Approves Farydak (Panobinostat)

This is a victory for myeloma patients, and perhaps for all patients facing a life-threatening disease.

Farydak (panobinostat) is a new oral drug approved specifically for use with bortezomib (Velcade) and dexamethasone to treat patients who have previously undergone at least two prior regimens, including Velcade and an immunomodulatory agent (thalidomide, Revlimid, or Pomalyst).

It comes with this boxed warning:


In other words it can be very unpleasant and can put your life at risk.  Further, in addition to the symptoms listed in the box, it can cause a reduction in platelets, neutrophils, or red cells, and can cause other serious problems.

So why is this a victory for patients?  Because Farydak can extend the lives of patients taking Velcade by months, perhaps years, that's why.

Nevertheless, last November the FDA Oncologic Drugs Advisory Committee (ODAC) voted 5 to 2 against approval of Farydak, judging that the potential benefits did not outweigh the risks.  This is a panel of "experts" (not a patient among them) deciding by themselves what risks WE patients should be permitted to take, and attempting to block us from all access to this drug.  In a recent speech I said "for people in my shoes, the side effect of NOT having the drug is worse – we call it death"!  

All of the new FDA-approved drugs have a daunting list of possible side effects, but we take them anyway because we don't like the alternative.  And as a result the median survival for myeloma patients has doubled during the 12 years since my diagnosis.  In my own case the advertised side effects of my little magic pill have been mostly absent - I've run 58 marathons now in my seven years on Pomalyst.

I congratulate the FDA on their understanding of this issue and their willingness to let us, with our pretty damn smart doctors, make the life-determining decisions ourselves.  This seems new, and I hope it is a harbinger of things to come.

Farydak is new too.  It works on an entirely new principle - it's called a histone deacetylase (HDAC) inhibitor - with the potential to be combined with any of the drugs that work on other principles. There is much to be learned about Farydak.  I hope I never need it, but I'm glad to have it in my quiver.

For more about access to emerging treatment technologies, please visit Closing the Gap Now .

Saturday, February 14, 2015

Pomalyst Study Ends

But I'm still on Pomalyst, 2 mg daily with no days off, thanks to insurance.

Somewhat to our surprise, Mayo Clinic abruptly cancelled my participation in the study at the visit which ended my 89th 28-day cycle.  As far as I know the drug manufacturer, Celgene, was prepared to continue the study, but Mayo explained that they needed the resources elsewhere.

I headed home from that last visit with no meds and wondering how or when I would get them, and also wondering if or when I would have any appointment.  Happily, answers to those questions came in a few days (after some phone calls) and treatment is back on track.  My copay is quite manageable, and of course I'm aware that there are organizations that will help with the copay if I seek help.

I've now had my first "regular" appointment at Mayo, where we established a new schedule:  I will continue to get myeloma markers checked every month, but will actually drive the 200-mile round trip to Mayo only every second or third month, otherwise mailing in the blood samples and getting the results online.  The next Mayo visit will be in April and we will do either an x-ray bone survey or a PET scan at that time, to be determined after this upcoming marathon.

This time Mayo chose to do my CBC in the morning, together with all of the other blood tests, and found that the neutrophil count was barely above the lower limit of 1.0 k/uL.  We decided to go back to our earlier practice of taking the CBC the afternoon before the visit, because the afternoon neutrophil count is usually double the morning reading.  The neutrophils are there in the morning too of course - they apparently just don't like to get up early.  There may be a better medical explanation for that.

Results from the last study cycle and this first regular cycle indicate that the myeloma is still stable, with an IgG of 1270 mg/dL and M-Spike of 1200 mg/dL (1.2 g/dL).  Both of these values are within the range of values seen recently.  The myeloma will probably take over someday, but not yet.

At a gluten-free restaurant called Nourish in Gilbert, AZ.
That dressing is lime-based, perfect for the salmon and the salad.

Tuesday, December 9, 2014

Beta Blockers May Improve Myeloma Survival

ASH Monday, December 8, 2014

Yi Lisa Hwa, DNP, Mayo Clinic in Rochester, MN, noticed that one of her patients MM numbers improved when she prescribed the beta blocker propanolol. So she took a look back in time. In a retrospective study of Mayo patients seen between 1993 and 2010, 136 patients who had taken beta blockers were compared with 136 who were statistically matched but did not take beta blockers. Median followup was seven years.

Results: The five-year overall survival (OS) for myeloma patients taking beta blockers was about 62%, contrasted with OS of 47% for those not taking beta blockers.

This is quite a big difference, and it's real. In a discussion with the author, she did point out that beta blockers are now being used in treatment of other cancers. I doubt we have heard the last of this one in myeloma. How does it work? How much is enough or too much? Is it really the beta blocker, or is it the underlying condition or lifestyle that prompted the doctor to prescribe the beta blocker? There is work to be done.

Caution: Beta blockers are contraindicated for some people, and anyone contemplating the addition of beta blockers to their regimen should discuss it with the prescribing doctor. I myself probably should not take them, because my resting heart rate is too low. Darn.

Link to abstract.

Excellent Results with Pomalyst and Velcade

ASH Monday December 8, 2014

Dr M Q Lacy, of the Mayo Clinic in Rochester, MN, presented the results of a small phase I/II study of Pomalyst with Velcade and dexamethasone (PVD) for 42 patients who had prior Revlimid but for whom Revlimid was no longer working. Many had other prior regimens as well; two thirds had a prior stem cell transplant, and more than half had prior Velcade. The results are startling.

Overall response in these relapsed and refractory patients was 81%, including 82% of the high-risk patients. A complete response (CR) was seen in 19%, including a stringent CR in two patients. At 9 months, 72% were progression free, and the median progression-free period was a year and a half.

Quoting from the abstract: "PVD is a highly attractive option in patients with relapsed and refractory MM." Here is the abstract.

Monday, December 8, 2014

Breaking MM News From ASH

Revlimid Does Not Increase the Risk of Second Primary Cancers for Newly-Diagnosed Patients

I know patients who say that their doctor would not recommend Revlimid for them because the doctor believed that Revlimid posed a risk of second primary malignancy (SPM), meaning some other cancer in addition to MM. Some early studies seemed to indicate that, and some doctors have taken it to heart without paying much attention to contrary data, choosing to avoid Revlimid even when it may be the most promising option.

Now an organization called "Connect MM," consisting of doctors from medical centers all over the country and even including our own Dr Brian Durie, has presented a paper based on a data base called the Multiple Myeloma Disease Registry, compiled by the National Cancer Institute. The data base provided actual clinical data from 1493 newly-diagnosed multiple myeloma (NDMM) patients, who were enrolled at 243 different US sites and observed for an average of about 2 1/2 years.

Bottom line: NDMM patients taking Revlimid have no more risk of SPM than patients taking other regimens. Here is the paper. The only significant risk factor the doctors found was "prior invasive malignancy," meaning that you are more likely to get a new cancer if you have had one before.  No surprise there.

I've written about this before, arguing that the early data was misinterpreted and that Revlimid did not pose an elevated risk for SPM. This pretty much clinches it, at least for newly-diagnosed patients and it has some meaning for all of us.

ASH Saturday, December 6, 2014

The High Cost of Innovation

ASH is the American Society of Hematology (Hematology.org), and its annual meeting is the ASH Conference, or just ASH. This year ASH is in San Francisco, and we three are among the 20,000 attendees.

A few hundred people attended a session titled "The Rising Cost of Medical Care: Understanding the Problem and Exploring Solutions"  The underlying assumption is that the cost of health care is rising at an unsustainable rate, which may be true, and that a major contributor is the high cost of the new, innovative, (and often highly-effective) cancer drugs, which is debatable. First a panel of experts spoke on the issues, followed by questions from the floor.

Dr Hagop Kantarjian, from M D Anderson in Houston, was the first panelist and by far the most negative, roundly condemning the pharmaceutical companies and anyone who doesn't likewise condemn them. If it is possible to make a good case against the high prices, his talk did not do that, because it included provably incorrect information, outdated and superseded data, and assumptions that don't stand up. To his credit, he did conclude by saying that nothing would happen without intervention by the patients, which I believe is true but probably not in the way that he imagines. I learned something about M D Anderson.

In contrast Mr Alex W Bastian, of GFK Market Access, had a much more factual and reasonable presentation. Among other facts he showed data demonstrating that the cost of cancer care has remained at about 5% of total health costs in recent years. I wish I could recall more of what he said.

I asked, from a microphone on the floor, if I could tell a little of my story, as a patient, instead of just asking a question, and was given permission. I can't recall exactly what I said, and have no record of it (though there may be a video of the session somewhere), but here is what I think I said, or I now wish I had said:

          I was diagnosed with myeloma more than 11 years ago, and, with my family, have since traveled the country and run 85 marathons, living a vital and enjoyable life. I could do that because, for most of that time, I have been on an innovative new myeloma treatment called Pomalyst, just a pill that I take every night.

Where did Pomalyst come from? Someone discovered that thalidomide was a useful treatment for myeloma, and the profits from Thalidomide funded the research, development, and testing of Revlimid. Then the profits from Revlimid similarly funded the development of Pomalyst. That is how our system works. As long as a pharmaceutical company can see the possibility of a good return on their investment, it will be willing to innovate and take the risk of bringing a new drug to market. If we somehow remove that incentive, innovation will go elsewhere. Common sense.

An Australian doctor suggested to me that the government should be in charge of the entire process, so that it could be more fair. I doubt that it would result in more or better new drugs, and I suspect that everyone would oppose it, including the insurers, the pharmaceutical companies, and the patients.

I'm sure of two things: First, the system that we have is working. It isn't perfect, but it works for me and many thousands of others who are alive and thriving today because of the new treatments. Second, the sky is not falling. Or if costs of health care are rising unsustainably, the high cost of cancer drugs is no more to blame than any other aspect of health care.

I have had a wonderful life in the past 11 years. My wife and daughter appreciate it, as do my two sons, my brother and sister, and lots of nephews and nieces. Not only did I enjoy the birth of two grandsons in that time, but they got to know their grandpa. And isn't that why we're all here?

I think I did say most of that, and I'm impressed that they let me say it all. It will be the highlight of ASH for me.

Sunday, December 7, 2014

All Is Well

In recent weeks I have been approached by some people (well, at least two) who are concerned that I have not posted on this blog since August, wondering if something is wrong. Nope - everything is fine.

We've just been very busy, and the visits to Mayo Clinic have been "steady as she goes." Stable. I have actually written, on the running blog, about the marathons that we have run in Portland, Ottawa, and Vancouver since August.

Life at home has been exceedingly busy, however, as we are in the midst of moving five miles, from our lake home in Lake Elmo to a smaller and less-demanding townhome in Stillwater, MN. Moving is a bigger job than any of us really imagined. It's not over, either, but at the moment I am taking a little time off to attend the ASH conference in San Francisco.

I do have another meeting with my Dr L on Thursday, and I may post about that, especially if there is news. Since this is a case of "no news is good news," I rather hope there is no news. Meantime, I may post about what is happening at ASH.