Tuesday, June 23, 2015

End of Cycle Two

Tuesday, June 16, 2015:

I have been on a trial of a new oral regimen for two months now, and I am a little disappointed to report that there is no significant change in my numbers.  My IgG dropped from 1230 to 1190 mg/dL this month, and M-Spike from 1.2 to 1.1 g/dL, but both of those values are well within their recent variability.  The good news is that the numbers didn't go up!

Dr L tells me that this particular treatment regimen may take a while before it has a significant beneficial effect - several cycles perhaps.  I'll wait I guess - not much else to do.

All of the other numbers are OK.  Platelets are 144 billion/L, slightly below the reference range of 150 - 450 billion/L, but apparently nothing to fret about, so I don't.  Neutrophils and the rest of the white cell counts are dandy, red cells are fine.

Of course we don't know anything about the lesion in vertebra T5.  We can only see it with a PET scan, and we don't do those very often because of cost and also because of radiation exposure.

Peripheral neuropathy is an issue.  My feet feel somewhat numb, a little more than before this new regimen, and they tingle a little, but so far no pain.  I am keeping them warm and busy in hopes of slowing the nerve damage that causes the neuropathy.

In the meantime I am physically quite active with walking, running, cycling, and lawn mowing, living a life of quality and trying to keep the DEX (part of the new regimen) from disassembling my muscles.

Wednesday, May 20, 2015

End of Cycle One

Tuesday, May 19, 2015:

For most of the last seven years on the previous regimen I was happy when the results at the end of a cycle were the same as the results of the previous cycle.  "Still stable" was the byword.  We only changed regimens because of a T5 spinal lesion found by a PET scan.  I had hoped, though, that the results of this first cycle of the new regimen would show improvement, a reduction in IgG or M-spike, preferably both.


Nothing much yet.  Today my IgG was 1230 mg/dL, actually up just slightly (within measurement tolerance) from recent months, and M-spike was 1.2 g/dL, about the same as recent months.  No change there, but still stable.  Dr L did not seem concerned, pointing out that this regimen isn't as likely as other regimens to produce quick, dramatic results.

Something strange did happen to light chains though.  Both Lambda and Kappa went down, but Kappa went WAY down to a fifth of its value of five weeks ago, now below the bottom of the reference range at 0.3 mg/dL.  Dr L was not too concerned about that, and in fact said it means that something is happening!

We'll just have to wait another month.  Steady as she goes.  I'll be a patient patient.

PET Scan Lesion in the T5 Vertebra:

We will wait at least six months to look at this lesion again, because it can only be seen as a sugar-sucking bright spot on a PET scan.  PET scans are expensive and radiation intensive.  This is a dime-sized lesion in a bone that is actually fairly large, so Dr L didn't think that it seriously weakens the vertebra yet.

I asked if it is likely to be a new and different clone (since it showed up while IgG and M-spike were stable).  Dr L used the term "sub-clone," and said it is quite possible.  If so, however, we may not know soon because we cannot biopsy it, hidden behind the spinal cord from the back, and the lungs and aorta from the front.  We have to treat systemically.  My hope is that the new sub-clone is more responsive to the new regimen than the original clone was after this first cycle.  Hey, it could happen!


I have now heard from two friends who experienced painful neuropathy in their feet on my current regimen.  In contrast, however, Dr L said that only about 10% of patients have that experience.  So far I find myself in the 90% group - I feel some numbness in my feet and a slight tingling in my fingertips, but I'm not sure that either symptom is worse than it was before I started this regimen.  There is no pain and no loss of function yet.  I'm keeping my feet warm and busy, plus lots of Vitamin B.  Next month I will have an appointment with a Complementary Medicine doctor at Mayo, to discuss other neuropathy treatments and practices.


Platelets were lower than usual for me today, 134 k/uL, slightly below the bottom of the reference range, even though two weeks have passed since the last dose of the new drug.  On the previous regimen neutrophils were at risk, though mine never went below the study cutoff.  This regimen is more likely to affect the platelets, so if that count goes too low I could be at risk for internal bleeds.  Happily, this most-recent current platelet count is still well above the study cutoff of 25 k/uL.

Nevertheless I will be careful - as recommended by a knowledgeable Mayo pharmacist I have gone off aspirin and other supplements that could influence clotting.  Again this month I will be getting a CBC done locally prior to each new dose of the medicine.  If platelets (or anything!) are below the cutoff, we will stop the regimen at least until the numbers come back up again.

Plasma Cell Proliferation:

One of the results obtained from the bone marrow biopsy of five weeks ago is the Plasma Cell Proliferation Report.  This stuff is well above my pay grade (I am most definitely not a doctor), but as I understand it, "flow cytometry" is used to examine biopsied plasma cells more or less one-by-one.  Those cells which are determined to be monotypic (the myeloma cells) are examined by "quantitative DNA analysis" to see if they are in S-phase (in the process of dividing into two cells).  Dividing is bad - that's how cells multiply!

My report says "Monotypic Plasma Cells S-phase: 0.3%.  This means that about one third of one percent of the myeloma cells in that bone marrow biopsy on that day were dividing.  According to Dr L, that is actually a good number - my plasma cells are not going hog-wild on me (I believe the doctor used a medical term).

Further, this result corresponds closely to a 2008 biopsy result called the Plasma Cell Labeling Index, then used at Mayo Clinic but now mostly replaced by this flow cytometry result.  Still further, only one clone was detected - no new ones.  Meaning?  The plasma cells in that hip may not have changed much in 7 years on the prior therapy.  It is quite possible, though, that the cells in the T5 vertebra are a new clone, and we can't know yet how fast those might be dividing.  Fingers crossed.

Study Completion:

The Consent Form that the doctor and I signed does not mention a completion date for the study itself.  According to ClinicalTrials.gov, however, this study will reach completion in July of this year.  Dr L discounted that, thinking that's just the date at which the study will stop accruing patients, and the study itself will likely continue at least until the FDA approves the drug.

Monday, May 11, 2015

Day 21 of Cycle One

The trial specifies treatment doses on days 1, 8, and 15 of each 28-day cycle, the oral Primary drug plus dexamethasone (Dex) 40 mg.  I have taken all of those pills, and today is the sixth day after the last dose:
  • Myeloma results:  No information yet.  That's next week, on Tuesday, which is also Day One of Cycle Two.  Hope hope.
  • CBC Today: Good. White cell count is entirely normal, neutrophils especially, and platelets are above the bottom of the reference range.
  • Peripheral neuropathy:  Just before starting this trial I chanced upon a myeloma friend who had been on the same trial, but had to stop it because of painful neuropathy in his feet.  He said that it started with numbness.  I already have a slight numbness in my feet from prior therapies, so I have been very alert to changes, but so far have not felt any changes.  Fingers crossed.
  • Headache:  Yes, when coming off Dex, occasional and easily treated with naproxen (Aleve). 
  • Nausea, other stomach issues, rash, infection:  None.  I took one anti-nausea pill before the first dose, and none since.
So far this has been an incredibly easy regimen to take.

I'll post again when the myeloma results (IgG and M-Spike) are known.  The recent PET scan spotted a lesion in my T5 Vertebra, but I probably won't know the fate of that lesion for some months.

Monday, April 27, 2015

Day 6 of Cycle One


Good CBC.  As part of my new myeloma regimen, we do a CBC with differential at the end of each of the first three weeks, just before taking the next dose of the Primary Drug.  I get that done at the local clinic, with the results sent to Mayo Clinic.

I'm not a doctor, but I know what my doctors want to see in the CBC, and by that standard I'm doing great:
  • White blood count is 5.8 k/uL, higher than I remember seeing it in years and well within the reference range.  
  • Neutrophils, which have been lower than they should be and which we have watched with apprehension, are 3.5 k/uL, perfectly normal.  
  • Platelets are 172 k/uL, on the low side but about where they have recently been and also well within the reference range.  
We don't yet know if the first dose of this new regimen is fighting the myeloma, but the CBC at least suggests that it isn't hurting me.  I don't yet detect any side effects from it.  Tomorrow I'll take the second dose.  Three weeks from now we'll find out what is happening to IgG, M-Spike, and light chains.  I don't know when we'll look at the bright spinal lesion revealed by the recent PET scan, but PET is the only way to see it, so I hope we'll do that in a few months to confirm that the light has been extinguished.

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!


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.