Pomalyst (Pomalidomide) Approved by FDA

Five years ago two different therapies had failed to stop my myeloma's upward climb, and finally a PET scan showed holes in my bones. This was Stage I disease, and time for a treatment that would actually work for me! I went on a trial of CC-4047 (later pomalidomide, now Pomalyst) with dexamethasone, then eventually Pomalyst alone. It brought my numbers down quickly, and now my myeloma remains stable, with an M-spike of about 1.1 mg/dL. More-recent PET scans and X-rays have not found holes in my bones.

My family and I have enjoyed five free years, with a high quality of life. During that time I have been privileged to run 43 marathons in 34 different states which, added to previous marathons, comes to 70 marathons in 50 different states. Just last December, when I was 71, we finished that 50-state odyssey in Hawaii.

For those five years I have taken a little red Pomalyst pill every night, and have escaped the disabling injuries that myeloma can cause, but without the severe side effects and frequent clinic visits of regular chemotherapy. In fact, side effects have been minimal. It has been a miracle for me - I've literally been free to travel and free to run. I do take very good care of myself, with the best food we can find and plenty of exercise and sleep, but those few milligrams of Pomalyst most certainly have been the key. Now that Pomalyst is approved by the FDA, it has the potential to do for thousands more patients and families what it has done for us.

Pomalyst is evidence that research, innovation, and new technology are making a big difference to those of us with myeloma. Add the recent approval of Kyprolis and Velcade sub-cutaneous, plus more drugs in active studies and on the way to studies, and we have reason for a lot of hope. Dr. Durie of the International Myeloma Foundation (IMF) counted 700 different abstracts related to myeloma research at the recent conference of the American Society of Hematology (ASH). Myeloma is certainly not yet a chronic disease for most of us, but we are heading that way.

Here is today's FDA announcement, titled FDA approves Pomalyst for advanced multiple myeloma.

Live one day at a time and make it a masterpiece! - Dalai Lama

Neutrophils Are Higher in the Afternoon

Maybe not for everyone, but they sure are for me. My doctors and I have known that for several years now, and for the Pomalyst (CC-4047, pomalidomide) study I have gone to a local clinic in the afternoon of the day before my appointment at Mayo Clinic. Doing it that way, my neutrophils have always been above the 1000/uL lower limit enforced by the study. Below that limit a patient might be in danger of neutropenic fever or other problems, so the treatment regimen must be discontinued until the neutrophils reassert themselves. It's not cheating to measure the neutrophils when they show highest, I'm told, because they are really there all of the time. I guess they're late sleepers.

Today, though, Mayo Clinic inadvertently scheduled a CBC with differential for this morning, with a result of 910/uL, which is below the limit. According to the study protocol, that means I would have to go off the Pomalyst because, unfortunately, only the most-recent CBC can be used. Therefore yesterday afternoon's CBC, with its good result of 2000/uL, didn't count any more. That's a little dopey, but rules are rules.

This problem was easily solved, however. This same afternoon, yet another blood draw at the local clinic resulted in a satisfactory neutrophil count of 1600/uL, so my partcipation in the study is back on schedule. I had a capsule for tonight anyway, the last night of the current cycle, so we're all set for 29 more days.

Pomalyst Trial:

Today completes my 64nd 28-day cycle of the study of Pomalyst and my myeloma is still stable, as it has been for almost five years. IgG is exactly the same as last month, at 1140 mg/dL, while M-Spike dropped from 1.1 to 1.0 g/dL, though that drop may not be significant. Lambda light chains are up a bit but Kappa chains are up too, and the ratio didn't change much. Stable. Hoist a pint for Don.

We met with Mayo's doctor TR today, another delightful person. I asked her what to believe - if IgG stays constant and M-spike drops by about 10%, which is correct? She pondered that a bit and said "both." Now that I have had time to reflect, I guess it's possible that "bad" IgG really did drop, as shown by M-spike, and "good" IgG went up an equal amount. However, I suppose it's more likely that the difference is just due to measurement tolerances. Either way, "both" is the right answer.

Other Results:

Creatinine clearance is a rough measure of kidney function - higher creatinine means less kidney function. Today's creatinine measurement was 1.5 mg/dL, the highest I have seen in more than nine years. However, creatinine itself is a product of muscle breakdown, and if muscles have been heavily challenged then creatinine will be inherently higher.

I believe that today's result was an anomaly, for two reasons:

• (1) Two days ago I ran 18 miles at a pace faster than my marathon pace, and then shoveled snow for nearly three more hours. I was very tired and every muscle ached. Furthermore, just yesterday, I shoveled for another two hours, with more ache; and
• (2) I probably didn't drink enough water either day, especially after the 18-mile run, and kidneys need plenty of water to function correctly.

I predict that the creatinine measurement will be back within the reference range at the end of the next cycle.

Most-Recent Test Results:

Test		Nov 15		Dec 13		Jan 10		Feb 07		Remarks
M-spike g/dL		1.2		1.1		1.1		1.0		\ Tumor marker down
IgG mg/dL		1270		1250		1140		1140		/ Tumor marker same
Lambda mg/dL		2.92		3.25		2.56		3.09		L free light chains
Calcium mg/dL		9.6		9.3		9.6		9.6		OK
Creatinine mg/dL		1.2		1.3		1.2		1.5		Kidney, high
HGB g/dL		14.7		15.1		15.3		14.4		Hemoglobin, OK
RBC M/uL		4.13		4.31		4.41		4.10		Red cells low
WBC K/uL		5.5		4.4		4.1		4.9		White cells, OK
ANC K/uL		3.00		2.10		1.50		1.60		Neutrophils, Low

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		Somewhat technical. Best with a wide browser window.
My Supplement Regimen		With links to where I buy them.