CC-4047 Rocks Again

Three months ago I enrolled in a phase-2 trial (study) of Celgene's new IMiD drug CC-4047, with once-weekly dexamethasone. This third cycle brought another good result. My two primary markers, IgG and M-spike, are both down more than 50% after three months. This is an excellent response, especially since I stopped responding last year to thalidomide, a relative of CC-4047. I know that other patients have done well too. CC-4047 is not a cure for myeloma, but it may become a very important tool in managing it and an actual lifesaver for some who have exhausted other options. I hope it becomes more widely available SOON.

CC-4047 side effects for me:

• Bradycardia - my resting heart rate has dropped from about 48 to about 41.
• Slight reduction in red cell count and hemoglobin, taking both just below the reference range.
• Tinnitus from the aspirin that I take with the CC-4047.

No neuropathy, thromboses, leukopenia, neutropenia, or other difficult side effects yet, though these are all possible.

Dexamethasone side effects:

• "Peppy" and not-so-peppy days, fitful sleep one day a week.
• Increase in belly fat - I'm pretty sure this is happening.
• Loss of muscle mass, especially quads - my running speed is declining.
• High blood sugar levels on "dex day," as measured with glucose monitor.
• Thinning of my skin; it seems quite fragile now.
• Dex voice (tight).

Considering the good response and the dex side effects, Dr. L reduced the dex dosage from 40 mg to 20 mg once weekly for the third cycle just completed. We will continue with 20 mg for the fourth cycle.

I'm lucky, or blessed, in so many ways. Though I can't run as fast as I once could, that's unimportant in the big picture. Most important, myeloma has not yet hurt me. Aside from painless lesions inside three bones, I have no symptoms from the disease itself, and symptoms from the treatment are quite livable thus far. I wish that all myeloma survivors were so lucky, or blessed. Thank you for your prayers, and I offer you mine.

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."

Other things that Sunshine and I discussed with Dr. L:

• The loss of muscle mass and the thin skin, both caused by dex, may be reversible if I can ever stop using dex.
• There is not enough information yet on CC-4047, or on its relative Revlimid, to know if either drug is likely to cause other cancers or to change the myeloma to a more aggressive type. So far so good.
• The absolute amount of drop in IgG and M-Spike seems to be somewhat less for each successive cycle, and that trend is likely to continue. It's the direction that is important. I notice that the drop in IgG as a percentage of the previous measurement has been about the same from cycle to cycle, about 25%.
• I expressed the view that since the current treatment is working and there are lots of other treatments available, I might expect not to die from myeloma for five or ten years even without any advances in treatment. Dr. L thought that was not an unrealistic expectation. Cool.
• We talked about running a little too. :-)

A late-arriving result: Dr. L had my blood checked for stored ferritin, with a result of 32 ug/L compared with a reference range of 24 to 336 ug/L. It's on the low side; I need to research this and maybe discuss with my naturopath, Dr. H.



Tonight's celebration salad: Organic romaine, cucumber, organic walnuts, avocado, organic strawberries, blue cheese, organic red wine vinegar, organic pomegranate juice.

Dex and Blood Sugar, Part 3

In early April I did a little experiment, measuring my blood glucose approximately every half hour on three different days: (1) Dex day (after taking dex the night before), (2) the next day, and (3) the fifth day (hopefully no dex). Results are here.

I didn't like that much dex for several reasons, and when I showed the shart to Dr. L she reduced my dex dosage from 40 mg to 20 mg. This week I did the measurements again for "dex day," and found the glucose levels significantly lower, as expected.

Here are averages for each of three different days:

Dex		Glucose mg/dL
40 mg		144.3
20 mg		115.8
None		88.2

Bottom line: 20 mg of dex puts the average glucose approximately midway between 40 mg of dex and no dex. Huh - no surprise.

Here is a TABLE showing actual measurements and times.

Below is a chart. Click to enlarge.

CC-4047 Study at Ten Weeks

Yesterday morning I had the blood draw for ten weeks in the trial of the new drug CC-4047. Here is a table showing several CBC values on four different dates including yesterday:

	SMG	Mayo	Mayo	SMG
CBC	Mar 28	Apr 03	May 01	May 15	Minimum
WBC (leukocytes) K/uL	5.3	7.7	6.0	4.9	2.0
NE# (neutrophils) K/uL	2.6	4.98	3.26	1.7	1.0
PLT (platelets) K/uL	232	303	243	251	50
RBC (erythrocytes) K/uL	4.54	4.42	3.95	4.32
HGB (hemoglobin) K/uL	15.0	15.1	13.5	14.4

SMG = Stillwater Medical Group in Stillwater, MN
Mayo = Mayo Clinic in Rochester, MN

Dr. L at Mayo is especially interested in the top three counts. If the CC-4047 trial drug causes any of those three to fall below its displayed minimum, the protocol will be changed for me, or, eventually, I could even be dropped from the study. Leukocytes are down a bit and neutrophils are down more, actually below the reference range, but both are still within the normal range of fluctuation observed over the past five years. Good.

I am also interested in the other two. RBC and HGB are always near the low edge of the range for me, and in fact RBC is still below the reference range. But it is up slightly, so my non-medical opinion is that it is stable too. Good.

I left out one set of numbers, taken April 18 at Stillwater Medical Group (SMG). Those showed a lower value for WBC than I have ever had in the last five years, and higher values for RBC and HGB than I have had. My local Dr. L at SMG seems to agree that those are NOT my numbers; there was a mixup somewhere. He is also concerned about the OTHER person, who may have gotten MY results, which probably would have shown a sudden movement in the direction of anemia but no problem with the white counts.

Bottom line: Never make an important treatment decision based solely on ONE set of labs, especially if those labs are inconsistent with other recent ones.



Lunch of leftovers: Hearty chicken soup with free-range chicken, organic carrots, organic peas and more; organic brown rice pasta with organic corn, organic tomato and more; free-range bison with onions and organic carrots.

CC-4047 Rocks!

In early March I joined a phase-2 trial (Mayo Clinic study) of Celgene's new IMiD drug CC-4047, with once-weekly dexamethasone. My two primary markers, IgG and M-spike, are both down almost 50% after just two one-month cycles. This is an excellent response, especially considering that I stopped responding to thalidomide, a similar IMiD. Another patient that I know had an even better response on the same study, with markers dropping by half in just the first cycle. I have heard that other patients have done well too.

CC-4047 is not a cure for myeloma, but it may become a very important tool in managing it and, I'm sure, a lifesaver for some who have exhausted other options. I hope that Celgene will do whatever it takes to get it approved soon - people's lives are on the line.

CC-4047 side effects for me:

• Bradycardia - my resting heart rate has dropped from about 48 to about 41.
• Slight reduction in red cell count and hemoglobin, taking RBC just below the reference range.
• Tinnitus from the aspirin that I take with the CC-4047.

No neuropathy, thromboses, leukopenia, neutropenia, or other difficult side effects yet, though these are all possible. Albumin seems low, but other liver markers are normal.

Dexamethasone side effects:

• "Peppy" and not-so-peppy days, fitful sleep one or two days a week.
• Increase in belly fat - I'm pretty sure this is happening.
• Loss of muscle mass, especially quads - my running speed is declining.
• High blood sugar levels on "dex day," as measured with glucose monitor.
• Dex voice (tight).

Considering the good response and the dex side effects, Dr. L has changed the dex dosage from 40 mg to 20 mg once weekly. And the study continues, now well into the first week of the third cycle.

I'm lucky, or blessed, in so many ways. Most important, myeloma has not yet hurt me. Aside from painless lesions inside three bones, I have no symptoms from the disease itself, and symptoms from the treatment are quite modest thus far. I wish that all myeloma survivors were so lucky, or blessed. Thank you for your prayers, and I offer you mine.

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."

Free-range no-hormone no-antibiotic chicken, organic chard with dried cranberries, macadamia nuts, organic apple, organic pomegranate juice.

Lucky Don

If you skip over the fact of the cancer, I'm a very fortunate guy. The CC-4047 trial is so far very successful for me. After the first one-month cycle, IgG dropped from 2960 to 2230, and after the second cycle it is now 1610. Similarly, M-spike dropped from 2.7 to 1.9, and now to 1.4. This brings my markers back two to three years in just two months.

Best of all, side effects have been quite modest so far, the worst coming from the dexamethasone, not the CC-4047. The regimen will continue for another cycle, probably many cycles, but at half the dose of dex.

I am VERY happy!. Time for celebration. Much more to say about the results and my conversation with Dr. L, but no time to post it tonight. Big weekend coming, so it may be next week before I can bring it all together.