Pomalidomide Side Effect?

Pomalidomide keeps my cancer stable, but has significant side effects:

• Bradycardia (reduced heart rate). This doesn't bother me, but it does some people.
• Blood clots. These can appear as deep vein thromboses (DVTs) or pulmonary embolisms. They are life-threatening, but I haven't had one. I do take an aspirin a day.
• Peripheral neuropathy. The bottoms of my feet are numb in some places, and I have one thumb that tingles. From what I hear, my neuropathy may be fairly typical.
• Neutropenia, which is a low neutrophil count. Neutrophils are a major front-line fighter in the immune system, and without them we cannot easily fight off infections.

And I have an infection. At least four weeks ago, I apparently whacked the back of my hand against something, possibly outdoors working on a tree that we removed and cut for firewood. A bruise appeared, and a red circle around a tiny puncture. In the ensuing weeks the infection spread to three knuckles and the tissue between them, now overtaking most of the back of the hand and causing enough swelling to make it quite impossible to close the hand.

We've tried three different kinds of antibiotics in those weeks, with varying results. None of them reversed the infection, but one or two may have halted or slowed its advance. The one that may have worked the best, Biaxin, was stopped because liver enzymes appeared to go up, one of the risks of Biaxin. Now my local primary care physician, Dr LL, has me on a fourth antibiotic, doxycycline. We'll see how that goes.

Neutrophils may be important here - we really don't know HOW important, because we don't yet know the type of bacteria or fungus causing the infection. People with normal immune systems also get infections, but I sure haven't had one like this before. If necessary, we can stop the pomalidomide for a week and still remain on the study. But the myeloma is stable now, and I really don't want to mess that up!

Otherwise, though, life is wonderful. We three ran another marathon last Saturday.

Mayo Clinic Cycle 22, Still Stable

I've had trouble sitting down to write this post. The Mayo visit was November 12, almost two weeks ago. Plenty to say, but everything else intervenes, and I STILL don't have all the leaves picked up off the lawn.

Test Results:

At the end of Cycle 22 of the Mayo Clinic trial of pomalidomide with dexamethasone (DEX), no change in M-spike. Still 0.9 g/dL, which isn't bad. In fact the lab said it was 0.86 (verbal), but they round up for the written report because the test really isn't accurate enough to support two digits past the decimal. M-spike has hovered between 1.1 and 0.8 g/dL since June of 2008. IgG is up a little, but Lambda free light chains are down a little and the K/L ratio is up (good). Stable!

Calcium is back where it should be, and none of the other tests raise any eyebrows. Enough about test results.

Ashwagandha:

I've taken 225 mg of Sensoril brand ashwagandha every evening for the entire cycle. With no discernible change in test results, it's hard to say that the ashwaghanda has done anything, except help with a good night's sleep. Maybe I should double the dose. Instead, though, I'm now taking the pomalidomide at night, with the ashwagandha, rather than in the morning. That may make a difference, maybe not.

Peripheral Neuropathy:

Some months ago, after 15 cycles of pomalidomide, I noticed some numbness in the soles of my feet and a little tingling in my thumbs. No pain. I immediately did some research and started a new treatment for it, and the neuropathy stabilized. It hasn't changed much now in several months. I do not know whether my treatment is helping to stabilize it, because I haven't stopped the treatment to find out, but for what it's worth, here it is:

Daily dosage:

A good daily vitamin
A good multi-B vitamin
Vitamin B6	100		mg
Vitamin B12 sublingual	1000		mcg
Vitamin E	200		mg
Alpha Lipoic Acid	1200		mg
L-Carnitine	1000		mg
Bromelain	1000		mg
Flax Seed Oil	2000		mg
Curcumin	500		mg

Where it's necessary to take more than one capsule or tablet, I divide the dosage in two, taking half with breakfast and half with dinner.

I also believe in keeping the "peripherals" warm, because healing works far better when tissue is at body temperature. I wear wool socks most of the time, even in bed, and cotton gloves in bed. In addition, we eat very well (nothing that doesn't contribute to health), and get good exercise.

Things that are recommended (somewhere) but which I do not yet do:

• Topical emollient creams, with cocoa butter and spearmint, menthol, or even capsaicin, to stimulate nerves.
• Evening primrose oil supplement.
• "Magnesium Oil."
• L-Glutamine, up to 30 grams daily. I have it on hand, just don't find it convenient to take it.
• Pickle juice can work for cramps, maybe for neuropathy? One friend swears by it.
• Acupuncture.
• Transcutaneous electrical nerve stimulation (TENS). May have a temporary benefit.
• I don't smoke, but if I did I should stop! Duh.
• Biofeedback.
• Infrared heat.
• There are various gizmos and treatments advertised on the web. Buyer beware.

Related links:

	My Myeloma		A discussion of my myeloma, not very technical.
	My Treatment History		Not technical.
	My Test Charts		Graphic displays of several key test results over time.
	My Test Result Table		Best with a wide browser window. Very "technical."

Some current test results:

Test		Aug 20		Sep 17		Oct 15		Nov 12		Remarks
M-spike g/dL		0.8		0.9		0.9		0.9		Best tumor measure
IgG mg/dL		979		1070		1020		1100		Variation is normal
L FLC mg/dL		2.07		2.54		2.68		2.61		L Free light chains
Calcium mg/dL		9.7		10.0		10.3		9.8		Below 10.2 is best
Creat mg/dL		1.1		1.0		1.0		1.0		Kidney, lower is better
HGB g/dL		14.8		14.5		15.0		14.4		Hemoglobin, normal
RBC M/uL		4.13		4.01		4.21		4.00		Red cell count, low
WBC K/uL		3.9		3.7		4.2		3.9		White cells, normal

Discussion with Dr. L:

• She finished a recent marathon in a very nice time, despite having to wear a lot of clothing to keep warm.
• She thinks that my running inspires hers. As for me, I'm very proud of her.
• In answer to my question, yes, get a pneumonia shot.
• If ashwagandha didn't help in the first month, maybe in another month.
• There is a study of an oral form of Velcade.
• There is also a study of a drug currently in use for renal cancer.
• The pomalidomide trial is now open for people who have failed both Revlimid and Velcade.

American Society of Hematology (ASH):

Apparently it is unusual for a myelomiac to be able to run marathons. Thus far I have been lucky enough to avoid broken bones, and I've done eight marathons this year. The International Myeloma Foundation (IMF) has invited me to attend the annual ASH Conference, December 4-7, as an advocate for new treatments like pomalidomide. I will try to blog about it in real time, and will certainly report on it afterward.

Don finishing the OBX Marathon November 8

More Great News

Mayo Clinic Visit Thursday, August 20, 2009, end of Cycle 19

Pomalidomide works! At the end of the 19th 28-day cycle on the Pomalidomide / Dexamethasone Phase II trial my M-Spike is 0.8 g/dL, as low as it has ever been, IgG is 979 mg/dL, below 1000 for the first time ever, and neuropathy caused by the pomalidomide (CC-4047) is easily tolerated and has not increased in two months. No big breakthrough this month, just more evidence of a continuously stable or declining tumor burden. I'll take it!

Related links:

	My Myeloma		A discussion of my myeloma, not very technical.
	My Treatment History		Not technical.
	My Test Charts		Graphic displays of several key test results over time.
	My Test Result Table		Best with a wide browser window. Very "technical."

Here are a few of the latest test results:

Test		May 28		Jun 25		Jul 23		Aug 20		Remarks
M-spike g/dL		0.9		0.9		0.8		0.8		Best tumor measure
IgG mg/dL		1030		1010		1010		979		Variation is normal
L FLC mg/dL		2.60		2.63		1.95		2.07		L Free light chains
Calcium mg/dL		10.0		9.6		9.7		10.0		Below 10.2 is best
Creat mg/dL		1.0		1.0		1.1		1.0		Kidney, lower is better
HGB g/dL		14.4		14.0		14.8		14.5		Hemoglobin, normal
RBC M/uL		4.06		3.93		4.13		4.01		Red cell count, low
WBC K/uL		4.0		5.6		3.9		3.7		White cells, normal

Doctor:

Discussion with Dr KDS:

• My neuropathy has not become worse in the last two or three months. It reached a level where the balls and heels of both feet are partially numb, along with one thumb, and then it stopped advancing. It's quite livable, barely noticeable most of the time.
• I've lost four pounds in the past two months. Maybe. If so, it would be a very good thing.
• I have the usual litany of dexamethasone (DEX) complaints:
  • Thin, aged-looking skin, easily bruised,
  • Slow healing of wounds,
  • Slow running - muscles wasted, and
  • A new complaint: Sleep is hard to come by the night after "DEX day."
• I have been taking 8 mg of DEX once per week, and that will be reduced to 4 mg from now forward, by agreement of Dr L, Dr KDS, and myself.
• The next lower level of DEX on this Phase II Pomalidomide trial, after 4 mg, is NONE. I like the sound of that. Say it again: NO DEX!
• I've been on DEX for 18 months now. If I were NOT on a trial, Dr L and Dr KDS would probably have taken me off DEX by now, she said, because of its many negative side effects. The trial does not allow a participant to go back on DEX, however, so they haven't moved me off quite as fast.
• Soon, though, I hope. Life is wonderful, considering the alternative, and I've had far fewer symptoms than most from myeloma and its treatments, but assuming that the numbers will remain stable I'd love to get some running speed back. What a treat that would be.
• I asked what additional long-term DEX effects I should watch for. Her response was "myopathy," which basically means weakening of muscles. In this case I think we're talking about skeletal muscles, and it's certainly happening already, as demonstrated by the loss of running speed.
• My blood pressure was excellent this morning, 123/66, but pulse rate was only 39, even though I had just walked in to the exam room and sat down. She seemed unconcerned - I have a history of heart rates in the 40's because of the running.
• How low is too low? I suspect that my heart rate goes considerably lower when I'm dropping off to sleep. Seems like it does.
• We both believe the low HR to be an effect of the pomalidomide, not the DEX. It seems to reduce my HR at the high end, too, limiting my top running speed in shorter, high-energy races. Going off DEX wouldn't help that.
• Most people who have been on the trial for this long have had their pomalidomide regimen reduced to 21 out of each 28 days, rather than every day. In most cases this is done because the person's neutrophil count or white-blood-cell count (WBC) has dropped below acceptable threshholds. I still take it every day.
• My neutrophils are 1.45 K/uL, about as low as we have seen them, but still well above the threshhold. Ditto my WBC. They may be a little lower than usual simply because I haven't recently been exposed to a threat.
• Or maybe not. Platelets are low too, at 167 K/uL, though they also have been as low in the past. All three of these numbers could be depressed somewhat by the pomalidomide. That does happen to other people, and time will tell.

For this last cycle I took the pomalidomide in the morning, as often as I remembered to do it then, before eating anything at all. I thought that it might have the most impact if taken on an empty stomach. If so, it didn't seem to make a very big difference. Nevertheless, I liked that and will continue doing it that way for the next cycle. DEX will be taken with Sunday dinner, as it was during this cycle.


Breakfast after a 5-mile run. Oatmeal below, most things are organic including the globs of yogurt.