2nd Relapse Confirmed – Day 151 After 2nd ASCT – October 16 2012

I met Clay Smith, MD and Lindsay Davis, MD Fellow at the University of Colorado Hospital today and liked both of them. My sister, Jani, went with me to my appointment. I know I look too happy for a gal in her second relapse — but, happy is better than sad.
As I suspected, Dr. Smith thinks I have relapsed based on my M-Spike of 0.4, increasing LDH levels, and increasing immunoglobulin G and wants to do a bone marrow biopsy tomorrow, Wednesday morning, to confirm the relapse. They also drew the SPEP tests today which take several days to get back.
Afterwards I will get my Velcade chemo, dex, and some fluids. My kidney function test done on my blood called creatinine, is sky high at 1.47 (norms 0.4 to 1.20) indicating that I have kidney damage of some kind, so they are going to give me fluids IV with my chemo today. I think the creatinine is up because of the Zolinza (vorinostat), but Dr. Smith thinks it may be due to the myeloma building up in my bone marrow. I probably should have stopped the Zolinza sooner.My platelets are low at 80 (norms 150-400). However, my white blood cell count was fine at 4.3 (norms 4-11) and my hemoglobin okay at 12.1 (norms 12.1-16.3).
Since, Dr. Smith is sure I HAVE relapsed, he has already started the approval process for a the new multiple myeloma approved drug,

FDA approves Kyprolis for some patients with multiple myeloma

FDA NEWS RELEASE

For Immediate Release: July 20, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Kyprolis for some patients with multiple myeloma

The U.S. Food and Drug Administration today approved Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.

A form of blood cancer that arises from plasma cells, multiple myeloma usually grows in bone marrow, the soft, spongy tissue found inside most bones. The bone marrow is where normal blood cells are produced. In 2012, an estimated 21,700 people will be diagnosed with multiple myeloma and 10,710 will die from the disease, according to the American Cancer Society.

“The approval of Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease.”

The safety and effectiveness of Kyprolis, which is administered directly into a patient’s vein (intravenously), was evaluated in a study of 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid (thalidomide).

The study was designed to measure the percentage of patients who experienced complete or partial disappearance of tumor after treatment (overall response rate). The overall response rate was 23 percent. The median duration of response was 7.8 months.

The most common side effects observed in more than 30 percent of the study participants were fatigue, low blood cell count and blood platelet levels, shortness of breath, diarrhea, and fever. Serious side effects seen with Kyprolis included heart failure and shortness of breath. Patients should be monitored closely and treatment withheld if these serious side effects occur.

The drug is being approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs. The company is required to submit additional clinical information after approval to confirm the drug’s clinical benefit.

Krypolis is marketed by Onyx Pharmaceuticals of South San Francisco, Calif.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The World of MM

I’m in the middle of my marketing class right now. Clearly, I am paying attention.

Here are some links to news and updates in the Myeloma world. I’ll explain them in further detail when I get home!

Carflizomib gets fast-track designation from FDA for treatment of refractory/relapsed Multiple Myeloma patients. Yay! Click HERE

Revlimid Maintenance and Secondary Cancers – More details emerge. BOOO! Click HERE

Why should you take Dex(amethasone) with food? Click HERE

US 52 Was Under Water

We three drive down US 52 from the east side of St Paul to Rochester once every 28 days for my checkup at Mayo Clinic. It’s the shortest, fastest route. Usually we get up at 3:50 am, take an hour to shower and get ready, then 90 uneventful minutes later I’m in line for my 6:30 am blood draw. We knew that Thursday would be different, because of the heavy rain, but we didn’t know how different. A check of MNDOT’s Traffic Conditions Website showed that US 52 was closed, so we went another way – no fun driving in “driving” rain, but US 61 & 63 were open and it took us only about a half hour longer. Heading back, that MNDOT web site said that US 52 was open again, so we started out that way. Just a few miles south of Pine Island, though, we found water rushing across the four-lane highway. Some vehicles were crossing it, but some were not and we turned around. Police were conspicuously absent. At 5 pm the local news said that US 52 was closed right where we encountered the water.

We later discovered that the city of Pine Island had in fact become an island, though it normally is not.

IgG versus M-Spike:

IgG is a measure of ALL Immunoglobulin G proteins, good and bad, where M-Spike is a measure of just those Immunoglobulin G proteins that are monoclonal, the bad ones, all exactly the same. Medically, M-Spike can never be higher than IgG. Thursday my IgG was 1070 mg/dL, but M-Spike was 1200 mg/dL (1.2 g/dL). Not possible. I hate that! I was feeling pretty good about another “stable” result until that M-Spike came bombing in.

I asked Dr KDS about this impossibility – which number is most likely to be wrong? She wasn’t sure, but assured me (paraphrasing here) that she has seen this before, because both tests have an error tolerance, but that she was NOT worried. Further, I’m still stable and, as always, let’s see what next month brings.

Sigh. I fret about this stuff, and was hoping for a fret-free 28 days. I’ve been on the pomalidomide (CC-4047) study for 33 complete cycles now, and it has done a fine job of keeping me stable. Nevertheless, I know that the ride will end some day and I will need to take a different course of drugs that may have much worse side effects. So I’m always wondering if that time is near and hoping that it isn’t.

For now, though, I’m going to try to convince myself that the M-Spike number is wrong. There is nothing in the other cancer markers to suggest an increase in tumor burden. Calcium is fine, kidneys are fine, liver is fine, and light chains are not much changed. In fact, an IgG measurement of 1070 mg/dL is actually a decrease of 3% from August and 8% from July. We’ll go with that.

Carfilzomib:

Mayo Clinic will soon start a trial of this brand-new drug. Carfilzomib is a proteasome inhibitor, like Velcade, at least as effective but much less likely to cause painful neuropathy. Furthermore, it can be effective in patients for whom Velcade has failed. I blogged about it here. I’m not sure what it will take to qualify for the trial, but if you go to Mayo you might ask about it.

Velcade:

I am not a medical doctor, so you shouldn’t believe anything that I say. Nevertheless: If you are offered twice-weekly Velcade as a treatment, just say NO. Twice-weekly infusion is still the official, approved regimen, even though several studies have shown that once-weekly infusion is much less likely to cause painful neuropathy in most patients. In addition, there can be a threshhold effect: if a patient on twice-weekly infusions does develop neuropathy, switching to once-weekly may not help the neuropathy much. Once you get the neuropathy it’s yours to keep, and any amount of Velcade will reactivate it. A patient who starts out with once-weekly infusions, however, is much less likely to develop serious neuropathy in the first place. If your doctor insists on starting out with the official twice-weekly protocol, change doctors. No kidding. Velcade is an excellent drug, but it’s useless if the neuropathy prevents you from taking it.

Some current test results:

Test