Not Dead Yet

Not even close, doing pretty well actually, though I should post more often. I was diagnosed with myeloma in July, 2003, and according to my math that’s well over 16 years ago. My family and I go to two different support groups, and I get celebrated as one of the long-timers. I like that, so very preferable to being dead, I think.

I’ve been on Pomalyst (Pom) since March of 2008, with the exception of one year when the Pom trial ended. Trials of three different experimental regimens failed me then, but Darzalex became approved and the combo of Darzalex, Pom, and dexamethasone (dex) brought my numbers way back down. Eventually we eased up a bit, gradually dropping the dex altogether and reducing the Pom from every day to 21 days out of 28. That may have been a mistake.

Mayo Clinic Rochester MN

IgG and M-Spike stayed way down for three years, but last spring my shoulder began to hurt and my lambda light chains crept up almost to the top of their range. A PET scan showed a bright, colorful lesion in the right scapula, even though IgG and M-Spike said nothing about it.

The radiation treatments started the very next Monday, 10 daily sessions with breaks only for weekends. When that doctor heard that I was 16 years from diagnosis, he allowed that my myeloma must be “indolent,” like a lazy schoolboy. Well OK, but here it was threatening the use of my right arm! Happily, the PET scan after that treatment showed only a very small lesion remaining in the scapula. Doc did good.

I’m back on Pom every day, Darzalex once a month, and dex 12 mg/week. The arm feels great, IgG and M-Spike are fine, and lambda light chains are right in the center where they belong. We’ll find out more with another PET scan in March at Mayo Clinic.

Myeloma Beatdown

Blogging again.

June 26, 2019.

After a lovely, easy, three-year ride on a two-drug myeloma
regimen, my right shoulder was hurting and a PET scan showed a lesion (a
collection of myeloma cells showing bright red) in my right scapula.
M-spike and IgG hadn’t changed, but Lambda Light Chains had more than doubled.
The myeloma was back. It never gives up.

My Mayo doctor ordered radiation treatment of that lesion, and added
dexamethasone to the two-drug therapy. Now, a month later, the ten
radiation treatments are complete and I’m taking the dex. Last week’s
blood test showed Lambda light chains back down to normal again, a very
good sign.

Another PET scan and doctor’s appointment in a couple of months will tell us whether that scapula
really is better. I think it is, because my shoulder doesn’t hurt any more. It itches a little, because the radiation lightly toasted the skin over the scapula, but I don’t mind and it will heal.

A lesson learned:  A lesion formed but neither M-Spike nor IgG went up, which means that at least some of my myeloma is “nonsecretory” (doesn’t secrete monoclonal proteins).  Therefore we’ll have to pay more attention to Lambda Light Chains. Maybe I’ll need more PET scans too?  I wonder if there’s a limit on those these days. Checking Lambda Light Chains is just a simple blood draw for a lab test, though it’s nowhere near as comprehensive as a PET.

Good News Again

Stable:

Since April of 2016 my treatment regimen has been Pomalyst (pomalidomide) and Darzalex (daratumumab), with dexamethasone in the early months.  That combination brought my IgG and M-Spike down to the lowest levels seen since diagnosis 14 years ago.  M-Spike has not been above 0.5 g/dL since August 2016, and it was 0.5 again last Tuesday.  IgG was 536 mg/dL, about where it has been for more than a year.  This is wonderful.

The Darzalex protocol (with Pomalyst) calls for infusions once per week for 8 doses, then every other week for 8 more, and finally once per month “until disease progression.”  So far so good.  Darzalex is an infusion that takes several hours, but I get a blood draw, then a visit with the hematologist, and finally the infusion, and I’m still out soon after noon.  Some people bring a book to read – I bring my laptop and it’s no problem at all.

I take it easy for the rest of the day, and life is back to normal the next day.  Darzalex is given with some prednisone (or dexamethasone) to reduce the likelihood of an infusion reaction, and I do feel some side effects from that steroid, but none from the Darzalex.  Life is good.  28 Infusions of so far – I wonder what my life would have been like without that potent, innovative new medication.

Pomalyst has been part of my treatment regimen, 2 mg daily, for all but one of the last nine years.  For the past two months my doc and I have tried cutting that to 2 mg for 21 of each 28 days, with no discernible increase in M-Spike or IgG.  Perhaps we’ll reduce it more, we’ll see.

PET Scan:

This was encouraging too.  “Essentially complete metabolic response of lytic bone myelomatous lesions to therapy. No new FDG avid lesions.”  In other words, the old myeloma hot spots are gone and there are no new ones.  Three other findings were worthy of note:

  1. Some inflammation at the bottom of the esophagus.  This matches my own symptoms of occasional acid reflux.  Something to deal with.
  2. Stable, chronic thyroiditis.  Yup.  Dealing with it.
  3. “Reactive FDG activity at the origin of the right hamstrings.”   No kidding!  I’ve been battling this running injury all summer, and my sports doctor recently used ultrasound imaging to diagnose it.  He’ll be happy to hear that the PET scan confirms his diagnosis.  Cool!  I’ve requested a disc with the actual PET images (always do), and can’t wait to see it myself.

Transplant:

In 14 years with myeloma I have not had a transplant, because for all of that time the medications have kept my myeloma stable.  I asked the doc if there was any reason to think about collecting stem cells for an autologous SCT now, and he thought not.  I’m already 76 and currently on a good regimen, with several new therapies to try when the current one fails, and with more therapies in the FDA-approval pipeline.  By the time those options are exhausted, I’ll hopefully be too old for any transplant doctor to consider me a good candidate.  So now my goal is to become the myelomiac to live the longest without a transplant.  Well, somebody’s got to do it.

PET Scan Looks Good

Before I started the current regimen, a PET scan last April 9 displayed five different lytic lesions, three of them in the spine.  Last Wednesday’s PET scan showed that all five lesions are significantly decreased, and most are gone.  One isn’t even mentioned.

This is excellent news.  We knew that my M-Spike and IgG were down to about 40% of their April values, but that doesn’t guarantee freedom from bone damage.  With these PET results, we can be pretty sure that no damage is occurring.  As we looked at the PET images together, Dr WG showed me a small chunk missing from a vertebra – looked like about BB size – damage that did occur before this regimen, but probably not bad enough to put the vertebra at risk of breaking.

So what is this potent regimen?  Please note: I am not a doctor.  This is working for me, but might not for you.  I am taking Pomalyst (pomalidomide) orally, 2 mg daily, 28 days of 28, and receiving infusions of Darzalex (daratumumab).  At first I received the Darzalex weekly, then every other week, and the last three have been four weeks apart.  According to the Darzalex prescribing document, these monthly infusions continue “until disease progression.”

PET Radiology Report

I’m all for that.  Notice, though, the presumption of disease progression,  Myeloma always figures out a way.  So now that the myeloma is stable, the hope is that the period of stability will last a long time.  Happily, neither medication brings serious side effects with it.

With the Pomalyst and darzalex I am also taking dexamethasone (DEX) 12 mg on the weeks with no Darzalex infusion.  I asked Dr WG if I could stop the DEX, but he said that he prefers to ramp it down slowly.  He voiced the scenario that I have feared from the outset – a broken vertebra would most likely put an end to my running lifestyle.  As he suggests, I will happily (or grumpily) take 8 mg once weekly for the next month at least, before reducing it further.  DEX is no fun, but 8 is better than 12.

Overall the news is good, and life is great.  Before long we’ll be off to Philly, to run the 100th marathon with myeloma.

How to Cure a Cold

They say there’s no cure.  And “they” may be right, but there are a lot of things that we can do.

Heard from doctors fairly recently (but note: I am not a doctor):

  • Gargle with warm salt water to sooth and treat the throat.
  • Use a neti pot (nasal irrigation) to clear sinuses.
  • Take Claritin (loratadine) and Claritin-D (loratadine with pseudoephedrine) to reduce symptoms.
Other common-sense and folk treatments:
  • Keep extra warm, particularly the chest.  Especially avoid getting chilled.
  • Get lots of sleep – morning and afternoon naps if possible.  In my opinion this is the best thing we can do.
  • Chicken soup with lots of salt and pepper.  Maybe other hot, salty, peppery soups with onion, sage, and thyme.
  • Zinc lozenges.
  • Vitamin C.  We mix Vitamin C powder in some organic pomegranate juice.  Yum.
  • Aromatic (menthol, camphor, …) rub on the chest for extra heat and a nice smell.  I clip a towel around my neck too.
  • Hydrate plenty.  Alas, alcohol probably doesn’t count.
  • “Feed a cold (and starve a fever).”  To keep the immune system strong, but junk food won’t help.
  • A key point:  Don’t let up until the symptoms are all gone.  A chest cold will take advantage of a chill to start all over in the sinuses, or vice-versa.
The old joke – Do all of these things and the cold might be gone in as little as a week.  Otherwise it might take as long as seven days.

I have a cold and I’m only on day 5.  As we say in Minnesota, Uff-Da. 

02

All Good News

Friday, August 19, 2016:

Wednesday I brought a Mayo Clinic blood draw “kit” to the local clinic, where they drew the blood and shipped it overnight back to Mayo.  Last evening the results showed up on Mayo’s patient portal, and I’m happy!

Since early April my treatment regimen has been 2 mg of Pomalyst every day, with infusions of Darzalex every week and then every other week, currently with 12 mg of dexamethasone (DEX) on the weeks between Darzalex infusions.  During that time my IgG and M-Spike dropped about 20% per month until a month ago, then leveled off.

Wednesday’s results confirmed that IgG and M-Spike are stable, at least for now.  IgG was 515 mg/dL two months ago, 544 last month, and 506 on Wednesday.  M-Spike followed a similar pattern and was 0.5 g/dL on wednesday.  These numbers are as low as they have ever been since my diagnosis 13 years ago, and just a third of their values of last April.  The chemo regimen is doing a great job for me.

Where to from here?  Could we cut the Pomalyst or the DEX?  It’s nice to think about, but mostly I’m just happy to be stable for now and content to wait another month.  I suppose another PET scan is indicated, to be sure that the lesions in my vertebrae have faded back (as I think they have), but I can wait for that too.  I haven’t heard from Dr WG at Mayo yet – perhaps he will have a different idea.

I also had a heart disease scare in the last marathon, but a recent stress test was normal, actually better than normal, so I think the angina-like symptoms were caused by acid reflux.  Also, because my most recent colonoscopy was ten years in the past, the doc ordered one of those and that too was negative.  I feel thoroughly checked out and ready to run a few more marathons!

Bright Sun and Clouds

June 22, 2016

Bright Sun:

After the 10th Darzalex infusion, with daily 2 mg Pomalyst and weekly dexamethasone (DEX), IgG is down once again, from 644 to 515 mg/dL, another drop of 20%.  M-spike is down too, by a similar ratio, from 0.6 to 0.5 g/dL.  Both myeloma markers are now at a level never seen in my 13 years

since diagnosis, and apparently continuing down.  It probably means that the actual count of myeloma cells in my bones is declining by roughly the same ratio, a very hopeful thought.

Clouds:

HEMOGLOBIN: For the first time in years my hemoglobin is down a little, at 13.2 g/dL, where it is normally over 14 g/dL.  This is not a problem in itself yet, because 13.2 is a very livable number.  Indeed, many of my friends with myeloma would be tickled to have that much hemoglobin.  It’s only a cloud because this is the third month in a row that hemoglobin has declined.  

The reason for the decline is a matching decline in my red cell count, now 3.8 trillion/L, where the bottom of the reference range is 4.32 trillion/L.  According to my Doctor WG, Darzalex can bind to the CD38 protein on red blood cells and thereby reduce their numbers.  In fact, according to the Darzalex Prescribing Information, a study showed that 45% of all patients experienced some level of anemia.  Dr WG didn’t seem too concerned, perhaps because I had run a marathon three days before without serious fatigue.  We’ll keep watching it – hemoglobin is measured before every Darzalex infusion, now every two weeks.

CHEST SYMPTOM: In the Vancouver USA Marathon last Sunday, three times along the way, I briefly felt a heaviness in the middle of my chest, accompanied by an ache going down both arms.  After further discussion, Dr WG said that I was recounting a classic description of angina, a symptom of heart disease.  The symptom appeared early and then disappeared in the latter half of the race, so I don’t believe there is imminent danger even if it was angina.

I have posted about this symptom before, concluding then that it was reflux (heartburn) and not angina.  I have an appointment with my primary doctor in a few days, and I’ll post as I learn more.

Review of ICER Report on Treatment Options for Multiple Myeloma

Who is ICER?

ICER is the Institute for Clinical and Economic Review.  As far as I can tell, it is funded primarily by insurance companies and by nonprofit organizations who, in turn, are funded by insurance companies.  They claim some funding by the federal government as well.  Other members include pharmaceutical companies who apparently participate in order to have some voice in ICER’s proceedings.  A quick Google search shows that the title of many of ICER’s documents is “Building Trust through Rationing,” which I believe is their mantra and suggests that rationing health care is their real purpose.

ICER deals in statistics, not medicine, and a primary goal is to control costs.  I assume that this is why they don’t want participation by patients.  They have been working on a report for multiple myeloma, and we myelomiacs have been concerned that they would produce a one-size-fits-all treatment algorithm that doctors might be expected to follow and insurers might try to enforce.

Garbage In, Garbage Out

ICER issued their final report on Myeloma on June 9, 2016, attempting to grade different myeloma treatments to provide comparative medical and cost values.  In my opinion this report is ridiculous on its face, saved only by one of its final recommendations.  ICER claims to have found over a thousand potentially relevant literature references to myeloma treatment, considered 38 worth reading, and exactly six Phase III studies worth analyzing to form their conclusions.

Thus they chose to ignore all Phase I and Phase II studies, which provide by far the largest part (I’d guess 90%?) of the current, up-to-date information that the FDA uses for myeloma drug approval and that doctors actually use in their day-to-day care of myeloma patients.  For this reason, ICER’s entire analysis is fatally flawed.  As we say in the computer industry: “Garbage in, garbage out.”

Blinders

As just one example of this blinders approach, the report ignores an old but widely-used myeloma treatment called cyclophosphamide (Cytoxan), which is frequently combined with dexamethasone (DEX) and either bortezomib (Velcade) or lenalidomide (Revlimid).  Indeed, many patients will recognize cyclophosphamide with bortezomib and DEX as the CyBorD regimen.  Because cyclophosphamide is relatively low in cost, it certainly should have been included in any economic analysis, but it appears nowhere except peripherally in the addenda.

ICER’s peculiarly superficial analysis also minimizes or omits many other commonly-used and highly-effective regimens.  Worst of all, it gives especially poor grades to the treatments that are newest and possibly the most effective, such as pomalidomide (Pomalyst) and daratumumab (Darzalex).

Saved by the disclaimer:

One recommendation near the bottom of the final report and in the shorter Report-at-a-Glance, saves the report from total disrepute.  This appears under the heading “Insurers:”

Multiple myeloma is a condition in which many patients will cycle through most or all available treatments, and there is substantial variation in drug mechanisms of action and in the personal patient values that guide consideration of the trade-offs between extended survival and different side effect profiles. Given this background, and in the absence of better evidence, payers should not consider step therapy or “fail first” coverage policies for myeloma treatments.

Amen.  This statement seems to have two important implications:

  1. ICER recognizes that their report has no value in guiding treatment for any particular patient (i.e. it turns out that we wasted our time producing this report); and
  2. The PATIENT (the payer) is responsible for choosing an insurer or a plan which does not demand step therapy or “fail-first.”

Let that be a lesson to us patients!  Maybe the best advice I’ve seen today – if you have a choice of insurers, choose very carefully.

My bottom line opinions:

  • A doctor attempting to use the results of this ICER report as the primary guide for treating a patient would be committing medical malpractice, and if so
  • It follows that an insurance company or plan that denied coverage based upon this report would be demonstrating a singular contempt for their own client, the policyholder.  

Whether you agree or disagree, or have a factual correction, you are invited to comment.  – Don

Yellow Roses

Wednesday, May 25, 2016:

My sweeties and I bought a nice bouquet of yellow roses to celebrate my latest treatment results.  In the last four weeks on Pomalyst (pomalidomide)(POM) and Darzalex (daratumumab)(DARA) my IgG has dropped 20% from 807 to 644 mg/dL, and M-spike 25% from 0.8 to 0.6 g/dL.  These numbers are the lowest that I have seen in my 13 years with myeloma.

Not all of that progress comes in the last four weeks, of course.  Here is a chronology of treatments and results since January, 2016:

  • Wed Feb 17 First Zometa infusion, serious reaction to something, likely the Zometa (not relevant to these results).  Still on two-MAB trial. 
  • Wed Mar 9 Last trial-drug infusion, then next day PET shows myeloma progression, stop trial and start POM immediately, 2 mg daily & 40 mg dexamethasone (DEX) weekly. 
  • Thu Mar 24 Myeloma markers tested after 2 weeks on POM/DEX & trial drug, which has a half life of about four weeks.  Numbers down, see chart. 
  • Tue Apr 05 After 4 weeks on POM/DEX & trial drug, M-spike down but can’t continue trial drug, start DARA next day. 
  • Mon Apr 25 After 3 weeks of POM/DEX & DARA plus fading trial drug, markers down significantly. 
  • Wed May 25 After 7 weeks of POM/DEX & DARA, IgG and M-spike down to all-time lows.

Currently all of the immunoglobulins that we measure, IgG, IgA, and IgM, are below the bottom of their respective reference ranges and lower than I have ever seen any of them.  Implications?  For sure, my immune system is weaker than normal, but I don’t know if it is actually weaker than it was before the POM/DARA regimen began.  I wish that IgA and IgM weren’t so low, but perhaps that is the price to be paid for now, because the myeloma tumor burden has been reduced significantly – has to be.

That’s the very good part.  I try to visualize the inside of my bones, dark red tubes with those little Y-shaped IgG Kappa immunoglobulins floating around hunting for the errant plasma cells and taking them out one by one.  Yee-ha!  Take that.

Somehow the POM plays an important part in this scenario too.  I haven’t figured out how to visualize that, but for now it’s enough to imagine that the POM weakens the cancer cells by reducing their fuel supply, or makes them easier to find, or recruits other parts of the immune system to help,
or whatever it is that POM does so well.

What’s next?  One more weekly infusion of DARA, and then, as long as the regimen continues to work, every two weeks until September, and every four weeks thereafter “until disease progression,” according to the Darzalex prescribing guide.  The worst-case result would be progression of the disease within weeks, and the best result would be a complete response, where immunoglobulin levels actually return to normal and the myeloma cannot be detected except by extraordinary measurement methods.  The most likely result is in between.  Time will tell, and patience is demanded even if patience is in short supply.

Technical thoughts:

For myeloma geeks: Darzalex is a monoclonal antibody which attacks the myeloma cells directly, just as my own antibodies and other immune defenses can attack them, but more effectively.  It is an immunoglobulin of type IgG Kappa, whereas my monoclonal myeloma cells are type IgG Lambda.  How do the measurements of IgG and M-spike distinguish between these two monoclonal antibodies, when I had received an infusion of Darzalex just the day before the test?  In each infusion I receive a 1200-mg dose of monoclonal antibodies.  When that is diluted by about 5 liters (50 dL) of blood (typical for a human body), it comes to 1200/50 = 24 mg/dL, which is a small value compared with the 644 mg/dL of my own (good and bad) IgG.  Check my math please.

However, since the Darzalex has an estimated half life of 18 days and I am getting weekly infusions, my blood contains more than just the most-recent dose, so maybe the correct amount is two or three times as high, perhaps 50 to 75 mg/dL.  That’s a guess – the actual math is well above my pay grade.  Even so, the concentration of treatment antibodies is only about 10% of the reported value of IgG, 644 mg/dL.  Dr WG suggested that the technician who reads the M-spike could separate the myeloma from the treatment, but I don’t know if that works for the quantitative measurement of IgG.  More to learn.

Personal thoughts:

Ms Wood Duck on our patio

Two grandchildren are visiting this weekend.  One is learning about birds, and watched a mother wood duck go into our new wood duck house to lay an egg.  The other is sitting in Grandma’s lap, helping her read books to him, or getting help from Grandpa’s in solving puzzles.  Precious moments all around.  When I was diagnosed the common wisdom was 3 to 5 years and out, but here we are 13 years later enjoying grandchildren who weren’t even born then.  I feel so lucky that novel medicines like Pomalyst and Darzalex have kept me alive to get to know them, and for them to know their grandpa.