2nd Opinion Scheduling - October 31 2012

I had a call from the secretary at the Mayo Clinic Scottsdale Arizona - Hematology/Oncology today. She wants to schedule my 2nd Opinion appointment with Dr. Rafael Foncesa who works with abnormal cytogenetics and relapsed multiple myeloma. I'll need to talk to Jani to help set the dates and travel plans since she will go with me.

• Clinical significance of chromosomal abnormalities in myeloma. Dr. Fonseca is studying the clinical, biologic and prognostic implications of specific chromosomal and genetic abnormalities for patients with myeloma. Ultimately, Dr. Fonseca and his colleagues believe that the accurate knowledge of the abnormalities underlying myeloma will allow for better management and treatment of patients. For instance, they have described the negative impact on prognosis of some genetic aberrations and better outcome with others.
  Further, Dr. Fonseca's lab has shown different pathology and clinical features of myeloma based on this genetic characterization. His lab was the first to show the clinical implications of the high-risk genetic translocations, including the t(4;14) and t(14;16). This information is now included in what the myeloma community calls high-risk myeloma. Many medical centers do not proceed to autologous stem cell transplants for patients with high-risk myeloma. Dr. Fonseca's studies have been converted into a clinical test available from Mayo Medical Laboratories. His lab was the first, in conjunction with Leif Bergsagel, M.D., to show the genetic basis of NF-kB upregulation in myeloma.

I faxed my allergy list and current medication list to the pharmacy in the Hematology/Oncology Department, Mayo Clinic Scottsdale this afternoon.

Cycle 1 Week 1 Day 2 - Carfilzomib 2nd Dose of Carfilzomib - October 31 2012

Woke with a slight all over headache (1-2 on a 1-10 scale), but otherwise fine. Didn't sleep very well because of the dex, so I worked on my computer several hours during the night.

Checked out of the motel and went to Walmart in Twin Falls, Idaho with Shirley Olsen. We arrived early at St. Luke's Hospital MSTI for my 2nd dose of Carfilzomib for the week and they took me early. No blood draw today.

I took 4 mg of dex orally and then the RN Letia checked my IV that we left in overnight with heparin flush in it. The site looked bruised this morning, but it ran like a charm and we were able to use it today too. 

The nurse hooked me to fluids and the Carfilzomib and more fluids. And it was nice to have Shirley Olsen's company.

I felt fine and throughout the infusions and was able to drive Jonah (1999 Honda Passport) all the way home to Mackay arriving around 4:15 PM.

Got the insurance estimate on Bart (2006 Honda Pilot) deer damage tonight - $4,200.13. The engine doesn't appear damaged beyond the cooling system which is toast.

Cycle 1 Week 1 Day 1 Carfilzomib - First Dose of Carfilzomib and No Heart Attack - October 30 2012

Shirley Olsen and I arrived at St. Luke's Hospital MSTI about 1 1/2 hours late for my appointment. I was immediately taken back for my labs. 

My white blood cell count is good at 4.8 (norms 4.5-11); platelets good at 151 (norms 140-440) and hemoglobin good at 12.8 (norms 12-15).

My creatinine (kidney function test) is still too high at 1.21 (norms 0.52-1.04). I'm not going to worry because my BUN is normal at 14 (norms 5-17). and BUN to Creatinine Ratio is normal at 12 (norms10-20).

My LDH was even higher today than last week - NOT GOOD. LDH 1,046 (norms 313-618). Last week was 993.

RN Janae got my IV started on the first poke and it didn't hurt at all. I was given intravenous dex 20 mg, followed by fluids, followed by my 1st dose of Carfilzomib, and then more fluids.

When the IV was completed, the nurse put heparin flush in my IV and sent me on my way since I have to have a second dose 24 hours later - tomorrow at 11 AM. We (especially me) are all hopeful that the IV will last through the night until tomorrow.

Shirley and I checked in to the Quality Inn in Twin Falls, Idaho for the night. I don't feel one bit different and I didn't have a heart attack from the first dose (a real possibility for some 7 percent of the patients on Carfilzomid in the past). 

It has been so nice to have Shirley along for the company. 

Took my first does of Revimid 10 mg tonight. As instructed, I do not handle the Revlimid capsules.

 So, that meant that I had to start back on Fragmin 15,000 unit injections in my stomach again - OH JOY~ Remember Revlimid can cause blood clots...and I was on daily Fragmin injections for 9 months from 2 Nov 2011 to 1 August 2012 for a blood clot in the right atrium of my heart...so, I'm no stranger to these shots. I'll stop the 81 mg of aspirin that I have been taking.

Never A Dull Moment On This Adventure - October 30 2012

Up at o'dark thirty to travel to Twin Falls, Idaho for my first dose of carfilzomid. Driving in the dark in Bart (2006 Honda Pilot) with my good friend Shirley Olsen who came along to help me if needed. Just 5 miles from the entrance to the Craters of the Moon National Park, out of the dark came a deer and which I hit and killed instantly. The radiator on the car was steaming and I could not open the driver's side door. The front end and hood don't look that damaged, but there are - hopefully there is not a lot of damage to the engine beyond the radiator.
I called Jamie Hjelm at Lost River Auto Body back in Arco and he said he'd be right out with the only tow truck in Butte County. It helps that I know him and have done business with him before. Although, this was my first deer hit EVER. Meanwhile, Shirley called her husband, Wayne, and our good friend Lesley Szabo to ask them to go to my house and get my other car, Jonah (1999 Honda Passport) and bring it to Jamie's shop about 5 miles north of Arco. 

 Jamie Hjelm of Lost River Auto Body, Arco, Idaho

Note the full moon over Bart. We were lucky because it wasn't too cold and no wind while we waited.

I have a photo of the deer, but I'm spare you that - took it for the insurance claim. 

Below, Shirley Olsen, Lesley Szabo, and Wayne Olsen (foreground) with Jamie Hjelm in the background.

We transferred everything from Bart to Jonah and were back on the road 1 1/2 hours late for my Carfilzomib appointment in Twin Falls. I called St. Luke's Hospital MSTI to let them know I'd be LATE.

Revlimid 10 mg Arrives and a Walk - October 29 2012

My 1st cycle of Revlimid 10 mg arrived FedEX this morning just after 11 AM.

I walked Kemmer to M&C Lube to have the oil changed in Bart this morning. Later I went walked back to get him. Total 0.83 miles for today.

Updates - October 28 2012

I forgot to mention the Mayo Clinic - Scottsdale, Arizona insurance office called yesterday (a Saturday) which surprised me since it was Saturday. I gave them my insurance information and they said they would be getting back to me. At least, I know the process has started.

Woke this morning with no ill effects from snow shoveling yesterday. My neuropathy seems to be extending from my feet and legs (especially left) to my back. I have a couple of spots on the left side of my back that feel NUMB and HEAVY.

Really warmed up today and most of our snow melted. Walked Kemmer 1.30 miles around town because the Mine Hill Road was muddy. No wind (note the flag on our American Legion Hall) and 60 degrees.

 My slow hair growth.

Snow and Good Energy - October 27 2012

It started to snow here in Mackay, Idaho last night - our first storm of the year with snow here in town.

This morning, we had only 2 inches of new snow. I used my snowblower and cleared the driveway.

Then, I went over to my father's house and shoveled his snow the old fashioned way - with a shovel - I like shoveling snow!

Walked Kemmer to the Big Lost River Smelter Bridge (1.2 miles).

 I wore my YAKS which I highly recommend!

I've felt good today and able to do lots of household chores like the laundry, changing sheets on the bed, vacuuming, etc.

Carfilzomib (Kyprolis) Authorization Completed - October 26 2012

I knew I posted a little early today - RN Peggy from St. Luke's Hospital MSTI in Twin Falls just told me that my carfilzomib has my health insurance authorization and will be ready for me Tuesday 30 October 2012 and 31 October 2012. I will get it intravenously 2 days in a row! If my Revlimid really arrives Monday 29 Oct 2012 - I'll start that for 21 days on 7 days off 30 October 2012 too. 

The reason the authorization process takes so long is probably related to the cost of the drug.

"Onyx announced the price of Kyprolis (carfilzomib) on 20 July 2012. The drug will cost $10,000 per 28-day cycle at the recommended dose for a patient of average size.

At that price and based on FDA-approved dosing schedules, Kyprolis will be the most expensive drug approved in the U.S. for multiple myeloma.

In comparison, Velcade costs between $4,000 to $8,000 per 28-day period, depending on the frequency of dosing, and Revlimid costs $7,900 per 28-day period at the FDA-approved 21-out-of-28-day dosing." From: http://www.myelomabeacon.com/news/2012/07/20/fda-approves-kyprolis-carfilzomib-for-relapsed-and-refractory-multiple-myeloma/

Things may be looking up for me if I don't have a heart attack from it  !

Nothing to Update - 2nd Relapse Medication Insurance Authorization - October 26 2012

Have heard nothing about the Carfilzomib approval today, so I called St. Luke's Hospital MSTI and had to leave a message for the nurse. I've decided to invest a LOT LESS angst in to this process - not good for me.

Curascript called this morning and said the Revlimid WOULD NOT be delivered today and I'll get it Monday - again, chill Jude, chill~

Terrible night of leg cramps - nothing seems to help except stretching and walking around. I took a plain Tylenol 500 mg with some success. Also had a gripping gut ache for awhile.

Walked Kemmer on the Mine Hill 1.38 miles - cold at 34 degrees, but very little wind which was nice. I should have had a red bandana on Kemmer to show that she is NOT A DEER during hunting season. I wore a bright red coat and hat, but Kemmer is often ahead or behind me and running the sage brush.

Nothing is Going Easy - October 25 2012

I've had calls from St. Luke's Hospital MSTI nurses, my insurance Case Manager, and Curascript - but, I still don't have approval for the Carfilzomib. The Revlimid is scheduled to be delivered tomorrow - we'll see~ And no news from the Mayo Clinic Scottsdale for the 2nd opinion yet either.

My 91 year old father was complaining of pain in his right leg below the arterial stents he had placed, so we called his doctor in Blackfoot, Idaho at Bingham Memorial Hospital. He ordered an ultrasound, so I drove my father the 90 miles to Blackfoot. After the scan we headed home through a HAIL storm on the desert of all things. Once we got into the Big Lost River Valley on Highway 93, it looked like we might go through a squall - but missed it.

My father's doctor called and said all was okay with the scan for now, but may need some intervention in the future. We didn't get home until after 6 PM - way past both my father's and my bedtimes - HA.

Bone Marrow Biopsy Result From 17 October 2012

My bone marrow biopsy results from 17 October 2012 were faxed to me today.

Bone Marrow Biopsy Surgical Report for 17 October 2012 (below 3 pages). 60 % plasma cells.

Bone Marrow Biopsy Phenotyping for 17 October 2012 (below 1 page). Positive for CD38, CD56, and CD138.

Bone Marrow Biopsy Genetics for 17 Oct 2012 (below 2 pages). Positive for abnormal cytogenetics.

Insurance Approval Delays and Walking - October 24 2012

Still do not have insurance approval for Carfilzomib and Revlimid. I called St. Luke's in Twin Falls and they are still waiting on the approval. I called my insurance Case Manager (she is in Ohio) and had to leave a message. No one seems to realize I need these medicines sooner than later. I lost my patience a bit. Today was a hard day to forget I have relapsed x 2 high risk multiple myeloma.

So, I walked Kemmer 0.68 miles on the Mine Hill today - always calming for me. Our summer route was covered with snow and slick, so we walked the steeper Mine Hill road today beginning at 6,232 feet with a gain in elevation of 132 feet or the equivalent of a 11 story building to 6,364 feet. Cold at 37 degrees, but no wind and mostly blue skies.

My left foot and leg neuropathy continue to burn, but during the day when I'm active it isn't too bad. However, during the night, it interferes with my sleep. 

Lab Values, Dr. Visit, Velcade, and Review of Carfilzomid - October 23 2012

Up early in the dark for my trip to St. Luke's Hospital MSTI (Mountain States Tumor Institute) in Twin Falls, Idaho. Left early because it snowed yesterday and so I could go more slowly watching for critters (deer, moose, elk) in the road, but I didn't encounter any.

My blood draw went well and I was careful to hold the site for 5 minutes afterwards since I expected that my platelets were improving, but still below normal.

My white blood cells were almost normal at 4.4 (norms 4.5-11); hemoglobin normal at 12.3 (norms 12-15); and my platelets were up from 80 last week to a normal of 149 (norms 140-440). So, my bone marrow is recovering from the Zolinza (vorinostat) in these values.

My creatinine was lower at 1.16 (norms 0.52-1.04) from 1.47 last week on 10/16/2012 and 1.20 on 10/20/2012. My BUN remains normal at 11 (norms 7-170. So, it appears that my kidney function tests are on the mend. I will continue to drink lots of fluids daily (3,000 to 3,500 ml).

My LDH is soaring at 993 (norms 313-618) - goes well with the relapse.

After my labs were back, I saw Dr. Padavanija and nurse Kendi. They have been working on getting insurance approval for the Carfilzomib (Kyprolis) and Revlimid (lenalidomide). I gave them my insurance Case Manager's phone number and they had to leave a message. At any rate, the new medications are not yet available and I got Velcade/Dex instead. I called Curascript and completed my Celgene Survery for the Revlimid 10 mg. They will send it to me as soon as the insurance approves it.

I'm thinking this is not all negative, since it will give my bone marrow another week to recover from the Zolinza (vorinostat) that didn't help me - just depressed my bone marrow and abnormally increased my kidney function tests.

The Carfilzomib (Kyprolis) information is a tad scary. I can only hope the benefits for me outweigh the risks and that Zolinza (vorinostat didn't ruin my heart - I still have flip-flop feelings in my heart and racing heart rate at times).

WARNINGS AND PRECAUTION Carfilzomib (Kyprolis) 

from http://www.kyprolis.com

The safety of KYPROLIS was evaluated in clinical studies of 526 patients with relapsed and/or refractory multiple myeloma.

Cardiac Arrest, Congestive Heart Failure, Myocardial Ischemia 
Death due to cardiac arrest has occurred within a day of KYPROLIS administration. New onset or worsening of pre-existingcongestive heart failure with decreased left ventricular function or myocardial ischemia have occurred following administration of KYPROLIS. Cardiac failure events (e.g., cardiac failure congestive, pulmonary edema, ejection fraction decreased) were reported in 7% of patients. Monitor for cardiac complications and manage promptly. Withhold KYPROLIS for Grade 3 or 4 cardiac events until recovery and consider whether to restart KYPROLIS based on a benefit/risk assessment. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications may be at greater risk for cardiac complications.

Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with KYPROLIS and was Grade 3 or greater in less than 1% of patients. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for pulmonary hypertension until resolved or returned to baseline and consider whether to restart KYPROLIS based on a benefit/risk assessment.

Pulmonary Complications
Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported. Monitor and manage dyspnea immediately; interrupt KYPROLIS until symptoms have resolved or returned to baseline.

Infusion Reactions
Infusion reactions were characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following infusion or up to 24 hours after administration of KYPROLIS. Administer dexamethasone prior to KYPROLIS to reduce the incidence and severity of reactions. Inform patients of the risk and symptoms, and to contact physician if symptoms of an infusion reaction occur.

Tumor Lysis Syndrome
Tumor lysis syndrome (TLS) occurred following KYPROLIS administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS. Prior to receiving KYPROLIS, ensure that patients are well hydrated. Monitor for evidence of TLS during treatment, and manage promptly. Interrupt KYPROLIS until TLS is resolved.

Thrombocytopenia
KYPROLIS causes thrombocytopenia with platelet nadirs occurring around Day 8 of each 28-day cycle and recovery to baseline by the start of the next 28-day cycle. In patients with multiple myeloma, 36% of patients experienced thrombocytopenia, including Grade 4 in 10%. Thrombocytopenia following KYPROLIS administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with KYPROLIS in < 1% of patients. Monitor platelet counts frequently during treatment with KYPROLIS. Reduce or interrupt dose as clinically indicated.

Hepatic Toxicity and Hepatic Failure
Cases of hepatic failure, including fatal cases, have been reported (< 1%). KYPROLIS can cause elevations of serum transaminases and bilirubin. Withhold KYPROLIS in patients experiencing Grade 3 or greater elevations of transaminases, bilirubin, or other liver enzyme abnormalities until resolved or returned to baseline. After resolution, consider if restarting KYPROLIS is appropriate. Monitor liver enzymes frequently.
Embryo-fetal Toxicity
KYPROLIS can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using KYPROLIS. Carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS.

ADVERSE REACTIONS

Serious adverse reactions were reported in 45% of patients. The most common serious adverse reactions were pneumonia (10%), acute renal failure (4%), pyrexia (3%), and congestive heart failure (3%). Adverse reactions leading to discontinuation of KYPROLIS occurred in 15% of patients and included congestive heart failure (2%), cardiac arrest, dyspnea, increased blood creatinine, and acute renal failure (1% each).
The most common adverse reactions (incidence ≥ 30%) were fatigue (56%), anemia (47%), nausea (45%), thrombocytopenia (36%), dyspnea (35%), diarrhea (33%), and pyrexia (30%).

USE IN SPECIFIC POPULATIONS

Since dialysis clearance of KYPROLIS concentrations has not been studied, the drug should be administered after the dialysis procedure.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call1-800-FDA-1088. For important risk and use information, please see full Prescribing Information.

Drove the 2 1/2 hours home and arrived by 2:30 PM. The roads were dry through the Craters of the Moon.

Also dry near Mackay, Idaho with snow on the MIne Hill. October 23 2012

Walked Kemmer to the Big Lost River Smelter Bridge (1.20 miles). Stopped to talk to a friend who was out looking for a photo opportunity.

Medical Insurance and 2nd Opinion Care - October 22 2012

I have excellent health insurance (Anthem) and I've been very thankful for that in the last 15 months since I was diagnosed with high risk multiple myeloma. 

Last night, out of the blue, but timely, my health insurance nurse Case Manager called. I filled her in on my need for a 2nd Opinion with my current relapse to 60 % plasma cells in my bone marrow and told her I wanted to go to Boston. She explained that Boston's Dana Farber is OUT of MY NETWORK and I could only go there if my doctor first wrote the insurance company doctors a letter of medical necessity explaining that Boston provides care that no one IN MY NETWORK could provide. After the insurance company receives the letter, it takes at least a week for the insurance company doctors to rule and it is not a given that they would rule in my favor. This doesn't mean I couldn't go to Boston, just a lot of hoops and a possible denial. 

My Insurance Case Manager explained that the Mayo Clinic, Scottsdale, Arizona is IN MY NETWORK and was one of the places my University of Colorado Hospital oncologist, Dr. Clay Smith had suggested last week for the 2nd Opinion. In addition, because Mayo is IN MY NETWORK, they will help me with the expenses involved in travel there (airfare, rental car, and hotel).

So, I called Jani and we decided it would be best to seek the 2nd Opinion at the Mayo Clinic, Scottsdale vs Boston. I emailed my nurse Transplant Coordinator at the University of Colorado Hospital and explained all of this. Unfortunately, they had already started the ball rolling at Boston, but Dr. Clay Smith was willing to change gears and contacted Rafeal Fonseca, MD at the Mayo Clinic for me. In addition, my Transplant Coordinator contacted the Mayo Clinic, Scottsdale, Arizona and let me know that that she has already started to fax my records there.

I am grateful to Clay Smith, MD and Lindsey McMenimen, RN, my University of Colorado Hospital doctor and Transplant Coordinator for their timely and hard work on my behalf. It helps to have people in your corner!

2nd Relapse Confirmed By Bone Marrow Biopsy Done 17 October 2012

I received part of my bone marrow biopsy results done on the sample obtained 17 October 2012 at the University of Colorado Hospital this afternoon. 

My bone marrow reveals relapsed plasma cell myeloma with 60 % kappa monotypic plasma cells involving a slightly hypercellular marrow (70 %) with mild anemia (low hemoglobin) and moderate thrombocytopenia (low platelets). I do not have the cytogenetic analyses yet.

So, this report is even worse than I thought it would be with an M-Spike measured at UCH on 17 October 2012 of only 0.3. Plus, it is clearly apparent that the 2nd autologous stem cell transplant did nothing for me.

I'll just have to wait for the referral to Boston and the approval of Carfilzomib and Revlimid. I go to see Dr. Padavanija at St. Luke's Hospital MSTI in Twin Falls, Idaho tomorrow. If they don't have the Carfilzomib approval, I'll get Velcade again.

Snowing in our mountains today.

Home Sweet Home in Mackay Idaho - October 21 2012

Feeling pretty good - better energy. My neuropathy continues, but I think it is some less intense. Didn't sleep well last night, so, hopefully, I will tonight. Got the house vacuumed and took Kemmer on a walk to the Big Lost River Smelter Bridge (1.20 miles).

The Big Lost River is really low right now.

 Could clearly see trout swimming around.