AG221 Trial Comes To An End

T-shirts given to blood donors during the Battle of the Badges, Beavercreek, Ohio. Donors were entered into a drawing for a trip to Alaska-therefore the Moose theme on the T-shirt!

Since the last post, Todd had another blood transfusion and a platelet transfusion on Wednesday August 31, 2016. His platelets were at 28,000, not below the prescribed < 10,000 to get a platelet transfusion, but he got platelets to boost his counts prior to a much needed dentist appointment to fill a few cavities the following day, Thursday, September 1. His hemoglobin was back down to 7.5 just about 9 days after his last transfusion on August 22, 2016, when he was transfused with 2 units of blood.

Our local fire and police department was sponsoring an annual blood donation drive called the "Battle of the Badges" on August 29, 2016, where blood donors show up for the police department or fire department to see which group can donate the most blood. I decided to donate for the first time in my life!  I've wanted to donate or organize a drive ever since Todd was first diagnosed with MDS and also when he was transfusion dependent the Spring of 2015, but I never did. For this event, I scheduled a time to donate after I got off work. I learned so much about the process:

• you need to drink lots of water the day of donation; 
• it takes about an hour to register and go through the screening process;
• there is a list of medications, mostly blood thinners, that should not be taken so many hours prior to donating;
• I was worried that I would be disallowed to donate after checking "yes" to having traveled outside the U.S. in the past 3 years, but once I talked with the nurse during screening, she said they were really only concerned about travel outside in the past year in certain countries, especially extended stays. We had gone to the Dominican Republic in the spring of 2014, prior to Todd's chemo and transplant. (I had to look it up, it seemed like longer ago than that!). 
•  They also had to prick my finger and test my hemoglobin. Mine was at 12.5 the minimum needed to donate. (Low end of normal but I passed!)
• I did not eat before I went and I guess that is not desirable!  Especially for a first time donor. They wanted me to go eat the proffered chili, cookies, and orange juice before donating, but I was worried about getting  home to Todd and Ellie who also needed to eat. So, instead, she insisted I ate something before I left.  She actually gave me permission to "pig out" when I got home! See: First time donors
• since 2007, women who have had children are no longer allowed to donate just platelets unless they have been grandfathered in, meaning they have been already a regular platelet donor prior to this date.   See: http://givingblood.org/about-blood/blood-testing.aspx
• The actual donation only takes about 15 minutes.

Everything went great! The nurses said they had a great turnout and they made sure to tell each donor that their donation could save 3 lives! They can separate your pint of donated blood into platelets, red cells, and plasma.  I was so happy to see all the selfless people who were there to donate, knowing Todd was needing 1-2 units almost every week, that I was ready to cry tears of joy!  The nurses also thanked each person for their donation.  I personally wanted to thank each donor too!!!!  The whole experience was so touching to me knowing Todd is needing almost weekly transfusions, that now I want to organize a blood drive in his honor!  Todd would not receive the exact blood donated, but it would go to our community blood bank, where Soin Medical Center gets their supply.  Will those who are local begin to consider donating?  I pray you will!   Stay tuned.  In the meantime, check out this link: Red Cross Blood Donor Eligibility Criteria

"Although an estimated 38 percent of the U.S. population is eligible to donate blood at any given time, less than 10% of that eligible population actually do each year."

-The American National Red Cross. 2016

  
Cleveland Clinic Trial Appointment Cycle 19, Day 1

Today's appointment at the Cleveland Clinic for his regular trial appointment and treatment was rushed. Since Monday was Labor Day,  many of the patients that had appointments for that day were deferred to today. The day started out unsettling.  First, we were told that the person scheduled to do his bone marrow biopsy called in sick. So, they were afraid they were going to have to reschedule it for another day! I'm glad the sick staff member stayed home, but I was upset that Todd may not be able to get the biopsy today!  I told Sam, his trial nurse, that any other time it would not have been a big deal, but there was so much riding on the results of this biopsy , i.e.  pursuing another treatment options, that I really didn't want it put-off nor for us to have to return in the next few days. She understood and said she would see what she could do. We had to wait about an hour to get labs and another hour to get into a treatment room. Unlike his local office, they can type and screen him for transfusion during his lab appointment, so this saved us some time.  After running behind two hours from all the waiting, we had doctors, nurses, and the pulmonary technician, all trying to come into his treatment room during his transfusion. It was crazy. 

His CBC showed his hemoglobin at 8.3, platelets at 27,000, Whites at .86 and ANCs at .67 (hovering close to neutropenia .5).  There was some real concern about the low white count and ANCs knowing that these low counts make him more susceptible to infections. They decided to give him one unit of blood since he was below 8.5 and probably would not be able to make it until next Wednesday to get a transfusion, when he goes to the local oncologist.  They were also concerned that if he had not received platelets last week that he would have likely would have needed them today. 

Luckily, Sam was able to get his bone marrow biopsy scheduled for around 3:00 in the afternoon. He normally doesn't take the "pre-meds" before the procedure, since he has had so many biopsies and knows what to expect, but today he took them. 

Unfortunately though, the results of the genetic blood tests done last week had not come back for review. So, we will have to wait until next week for both the biopsy results and the genetic panel.

In the meantime, Dr. Hamilton was fully convinced that the trial drug AG221, he has been on for the last 18 months, was no longer providing any response. In addition, the increased nausea and fatigue were only suppressing his appetite and desire to eat. He is still losing weight and there is no reason to continue the drug if it's not helping and prevents him from getting the nutrition he needs.

Another consideration for stopping the drug now is that it would allow a "wash out" required period of time off the drug before beginning a new trial or another treatment.

"For all these reasons, Todd was taken off  of the trial drug AG221 as of today."

For all these reasons, Todd was taken off of the trial drug AG221 as of today.  His nurse Sam will start the paperwork to close out his trial. I will be sad to lose Sam as Todd's nurse, since she only works with trial patients. She has been so good to us! She will be able to help us temporarily, until Todd starts a new treatment, and she has assured me that we will be in experienced hands in the future.

Todd wasn't able to get his Echo cardiogram appointment in today though; and it has to be done at the trial facility, meaning Cleveland Clinic. So, Sam was able to get an extension to have it done when we come back to discuss his test results and the start of a new treatment. 

So, after 18 months of visits for the trial, what will we do now?  How often will he need to go to the Cleveland Clinic? What are the treatment options?  As for visits to Dr Hamilton at CC, they will be scheduled as needed. No more mandatory 2 week blood draws, no more monthly EKGs, no more Echocardiograms and biopsies every two months. We were asked if Todd would be willing to allow these tests to continue for follow-up research purposes for trial study, but we haven't made a decision yet to commit to these since we live so far away and would be bound to do them. We will also lose the reimbursements for our expenses and hereafter will have to pay for any drugs needed that are on the market (like Revlimid) unless they can be obtained through another trial. In my last post, I mentioned the high cost of the drug Revlimid. Sam requested a quote from the drug company Celgene outlining the portion our current insurance would cover and/or what kind of assistance we could receive from them, but she hasn't heard back from them yet. I'm not sure it will matter, as Todd will be forced to apply for Medicare next month by Obamacare. Who knows what will be covered on Medicare and if we will have to purchase some kind of Medicare supplemental insurance to pay for what it won't cover. 

Other treatment options include going back on the monthly chemo drug Vidaza or maybe even a combination of Vidaza and Revlimid. Vidaza targets blast cells and Revlimid works by increasing red blood counts by working against the 5q cytogenetic chromosomal deletion that causes the anemia, and therefore the need for transfusions. 

 I feel like I need to start researching more trial options. Dr. Hamilton is still planning on talking to Dr. Stein and getting his insight after the genetic panel and biopsy results come back.  If Todd has both the IDH-1 and IDH-2 genetic mutations, he would be eligible for the trial drug AG881, which would be another option, albeit, a complicated one as we would have to travel to one of the 5 trial locations in the U.S. none of which are within a driving distance of less than 6 hours.

Todd will need to return to his local oncologist one week from today, September 24, 2016 to check blood counts.  Hopefully, we will have test results back and be able to make a consult appointment with Dr. Hamilton at the Cleveland Clinic too.

We appreciate your prayers and support.  I know Todd would deeply appreciate your phone calls. He lays around a lot because he is so tired and we rarely go out.  He really needs the encouragement.  He said that becoming transfusion dependent again brings back bad memories of when he was so sick after his failed transplant.  It is a vicious cycle of feeling his energy drain away more and more every day, until he can no longer put off another transfusion.  A special dish or treat might tempt him to eat for those who prefer to cook or bake.  A card, email, or text would also help boost his morale.  If you prefer to visit, please contact us first.  We ask that all visitors make sure they are in good health and haven't been exposed to sickness especially since his immune system is so low.  And, because he sometimes sleeps or take naps throughout the day, it might be best to call first before coming over, so you don't catch him sleeping.  I think it would be especially nice to receive visitors while I am gone at work during the day; that is when he is often alone now that the kids are all back in school.  It is also the time of the day he goes without eating.

God Bless!

Transfusion Dependency Continues.

Todd was tired and ready for a transfusion on our way to Cleveland Clinic August 17, 2016. The had a full day scheduled for him so we needed to start the day early which meant going up the night before. We usually stay at the Hope Lodge in situations like this but now that I'm working full time it is difficult to get there by 7 pm, the latest check in time. I would have had to take off work early on Tuesday in addition to taking off that Wednesday all day. Instead, Todd made hotel arrangements through the Priceline website. If you have never used it, you bid on a room for a certain price. But you have no choice of what hotel you end up with and there are no refunds.

We ended up with the Hilton Garden Inn Downtown Cleveland near the ball stadium. Sounded good. Unfortunately, we got a late start and didn't arrive until almost 11:00 after the long drive. Todd was exhausted. We went to our room and realized it reeked of cigarette smoke. We went back to the desk and tried to explain that Todd was a cancer patient, already didn't feel good and had a cough and we couldn't stay in that room. They informed us that it was a smoking room and that they couldn't move us because the entire hotel was full (which I find hard to believe on a Tuesday night).  They only offered to spray the room with a scent or put in an ozone filter machine, but that it would take hours!  I told them that neither option would rid the room of the smell plus he was exhausted and needed to lay down now. They refused to give us a refund saying their hands were tied because we booked through Priceline. I appealed to their moral obligation to do the right thing but once again said there was no other room. We also challenged the hotel for having smoking rooms in the first place when Ohio has been smoke free for over 15 years!  They said that since they were renting out a private space they could get around the laws and that they plan on getting rid of the smoking rooms when they remodel in the future. 

I don't mean to offend smokers. I have loved many people who were smokers,  most of them having died from the side effects. However, this is the reason why the laws are in place in Ohio: to protect non-smokers who have no choice in the matter. Especially sick people and children. Most smokers I know are conscientious and would gladly smoke outside. But this business wanted to make money on those smoking rooms they were having trouble selling. 

We said that Priceline listed the room as a non-smoking room, but the hotel insisted that they tell Priceline it may be a smoking room and it is Priceline's responsibility to tell consumers. I tried calling another hotel we had stayed at before. The entire hotel was non-smoking and they had a room at the Cleveland Clinic rate available but Todd was too exhausted to go. So we had to endure a night of smoke smell and no curtains. I called the GM but got voicemail. He called me back the next day while we were at the Clinic to offer us a free room but I refused.  I didn't want a free room then. He said it that every single room in the hotel that night was booked. I congratulated him and told him they apparently didn't need our patronage if they are that busy on a Tuesday night. I told him I don't want to stay anywhere that is not smoke free and I said with one in three people getting cancer it was likely he or the men working that night may have a sick family member and may be in our shoes one day. We showered, dressed, and tried to get out of there as fast as possible. I didn't want to walk around smelling like smoke all day!

When we arrived at the Clinic, Todd had to start his day of appointments with a few tests on his lungs, including a pulmonary function test.  We saw the pulmonary physician.  He asked several questions and reviewed the results of his prior lung CT in addition to the morning’s tests and said nothing looked suspicious.  He had no idea what was causing Todd’s cough.  He prescribed him some cough medication, but that was it. 

Next, was lab work.  They were going to give him at least one unit of blood even if his hemoglobin wasn’t below 8.0.  It had been hovering around 8.1 -8.3; not enough to get a transfusion but still not enough to give him energy.   Originally, the trial nurse didn’t have a treatment appointment scheduled for a transfusion, but on the Monday before, I knew he wasn’t feeling good and would likely need it. So, she was able to add it to the schedule.  It was a good thing, because he did need it.  His hemoglobin had dropped to 7.5 and they were going to give him 2 units.  We were waiting for the type and screen and results to come back when Sam the trial nurse and Dr. Hamilton came in to see him.  We were disappointed that all his counts had once again dropped even more:

Whites had dropped to 1.46; ANCs to .95, and platelets to 31,000. 

She thought it was likely that the trial drug AG-221 was losing its effectiveness.  There was just no other explanation. I was confounded when Dr. Hamilton started talking about other options: Revlimid (for patients with Chromosomal Deletion 5q), and even harsh chemo and a second transplant!  I didn’t understand why we were discussing this now; neither one of these last two options would have a high success rate at this point.  I thought we should have at least Revlimid to try and/or going back on Vidaza again before bringing those options up. She was also concerned that he was starting to lose a little weight.

While getting his transfusion, the respiratory therapist came in and gave him his Pentamidine Breathing Treatment and another trial nurse came in for his EKG.  He had to miss two other appointments, because of course, everyone was running behind and we couldn’t get to either.  One was to receive more immunizations.  I wasn’t upset about missing this one.  I didn’t think it was a good idea anyway; to be getting more immunizations with his counts so low. 

We drove through thunderstorms and finally got home around 9 p.m.  I was hoping he would start feeling better right away, but the next day, he felt faint and couldn’t drive home from a haircut.  Luckily he was near his mother’s house and stopped there to take a rest and then drove home a couple of hours later.  That day and the next day he still felt puny and didn’t get out of bed much. 

This concerned me, so on Thursday, I put a call into the doctor and she called me back on Friday morning, August 12.  I told her about Todd’s lack of energy and nausea.  I also asked why she brought up chemo and a second transplant.  She said she just wanted to discuss all of his options.  She said that if Todd started needing transfusions more often, that she would consider taking him off the trial drug and starting the Revlimid, but not until then. 

By Friday afternoon, I was concerned and decided to call Dr. Eytan Stein at Memorial Sloan Kettering in New York City. He saw Todd before he started on the AG221 and I knew he had a lot of trial experience with the drug.  I wanted to pick his brain about other options.  I left a message and by that evening, he called me on my cell phone at home.  We discussed Todd’s case and current condition, the great response he had with AG221, and then the steady decline of his blood counts.  He was surprised at Todd’s great results with the drug, but then said that they had noticed that some patients who stopped responding to AG221 who had the IDH-2 genetic mutation, often developed an IDH-1 mutation in addition.  For these patients, there was a new trial drug AG881.  He asked me to have Todd’s bone marrow biopsy, doctor’s notes, and latest genetic panel sent to his office for him to review.  

I sent an email to Sam, his Trial Nurse at Cleveland Clinic to request they send the information to Dr. Stein.  Unfortunately, they hadn’t done a genetic mutation panel since May 2015, so they would have to wait until his next scheduled bone marrow biopsy to get this, but she sent what they had.  We were charged $45 for this request, but I will pay it happily.  I decided last year that I would do whatever it takes, including seeing the best doctors, traveling to any hospital to help him. 

I talked to Sam on August 17, the following Wednesday and told that I didn’t want to step on Dr. Hamilton’s toes, but that I really wanted to hear what Dr. Stein had seen in his trials and practice that could be of any help to Todd.  I also asked her to call in blood work orders, as Todd was still feeling poorly and I feared he needed another transfusion.  She called them in for the next day, Thiursday, so if he needed a transfusion, he could get it on Friday before the weekend.  Stubborn Todd however, refused to go then.  He wanted to wait until Monday, August 22, 2016 to go have his blood work done that way they could use it for his trial draw and wouldn’t have to repeat blood work scheduled on Wednesday August 24, for his trial draw for Cycle 18, Day 15.  Well, that was a mistake, one he admitted later.  He felt horrible all weekend. He didn’t drive, leave the house, or get out of bed.  The Olympics were on TV, so that kept him entertained in bed between naps.  By early Sunday night, his cheeks looked red so I grabbed the thermometer!  He was running a low-grade fever or 100.3; enough to go the emergency room.  He refused to go. I conceded as we both thought it was just a neutropenic fever.  We kept an eye on it and it was down to 99.6 before bed.

In the morning, he took a shower and his temperature was normal.  I took him to Soin Medical Center for a nurse’s visit in the Cancer Center there on the 4^th floor at the appointed time of 8:30 a.m.  His nurse also felt that he had waited too long to come in and thought he looked especially jaundiced since he was so pale (low hemoglobin).  She said that she wasn’t going to let that happen again and scheduled him for another blood draw to check counts for next week, August 31, 2016. I was glad for that.  After waiting almost 2 hours since we arrived, we finally got his counts back:

Hemoglobin was a low 7.0.  Whites 1.0.  Platelets 22,000 (transfusion of platelets needed at 15,000) and ANCs at .7 (neutropenic at .5).  

She gave him all the necessary warnings about his care: Careful with hot showers because of getting petechia spots, bleeding while shaving, etc.  When she went to schedule the transfusion, she came back and said she set it up for the next day, thinking that was what he would want.  I was upset at this!  I told her that he needed the transfusion TODAY! And that we were not leaving without one; he couldn’t wait.  Todd was so sick, he didn’t feel like arguing with her; so I did!  She told us that it would take 3 hours for the type and screen, longer to get the blood ready, do the transfusions, and that we wouldn’t be done til 8:00 p.m. that evening.  I told her I didn’t care and questioned why she didn’t do the type and screen when she drew blood.  He had already told her that he knew he was going to need a transfusion.  We had already been there for 2 hours!  She said she can’t type and screen for blood type until the initial blood results come back and she gets orders for the transfusion.  To me, this could have been done at the same time; this is what they do at the Cleveland Clinic and I told her so.  Long story short, I was so glad that I took him and told my boss I would be late.  If not, I know he would have went home and waited the next day.  Then, he would have had another day of feeling  bad and getting up early again. 

It didn’t end up being as bad as she thought.  I wheeled him done to the Universal Care Area and they checked him in right away and got him a bed.  I made sure he ordered lunch, then I went into work for a few hours.  They had the first unit to him by 1:24 p.m.  I went back to the hospital about 4:20 and he was finishing his second unit.  We were out of there by 5:00 p.m.!

This is why the caregiver needs to be present to help with the decisions that the sick patient don’t feel like dealing with.  He didn’t want to argue with the nurse; he didn’t feel like it!  But I did!  He told me later that he was glad that he didn’t wait until the next day.  And unknown to the nurse, we were out 3 hours earlier than her prediction! 

That afternoon, I talked to Sam, his trial nurse at the Cleveland Clinic and let her know his numbers and that he received 2 units of blood.  She said that she was feeling pretty sure that he was losing his response to the AG221 and would talk to Dr. Hamilton.  She was also concerned with his low white and ANC counts and would also discuss putting him back on his Cipro antibiotic as a preventative measure.  After talking to Dr. Hamilton, Todd was ordered to take his Cipro 2x a day and we were told that Dr. Hamilton was going to talk to Dr. Stein at Memorial Sloan Kettering to discuss Todd’s case and the option of taking him off of the trial drug AG221 and putting him on Revlimid. 

The transfusion seemed to help.  He was able to get around yesterday and even drive.  I am feeling a sense of urgency to get his medication changed and was greatly relieved that the two doctors are going to talk.  

The trial for AG881 is only available at 5 US locations: New York, Chicago, Boston, Aurora Colorado, and Texas. We won’t be able to find out if he eligible until he has the genetic panel processed on his next bone marrow biopsy at the Cleveland Clinic at his next appointment on September 7, 2016.  Then, it may take a few weeks to get the results back.  I’m hoping in the meantime that they can start him on Revlimid.

Did I mention that Revlimid (Lenalidomide) is on the market already and that it is very expensive?  According to Wikipedia, the cost for one year’s use was about $163,381.00 in 2012. (Wikipedia, 2016). Drugs.com quotes a 10 mg tablet, the starting dose for MDS patients at $16,457.14 for one month’s dose of 28 tablets!  (Drugs.com. 2016). I’m praying we will not have to pay all of that between insurance and a request to the drug company, Celgene, to buy it at a reduced price.  Of course, there is no generic available.

I'll post after blood work next week. Until I continue with my mantra:  Whatever it takes!

For More Information: 

Alsumidaie, M. January 2, 2015.  “The Cost of Saving a Cancer Patient’s Life” Applied Clinical Trials. Web. Retrieved from: http://www.appliedclinicaltrialsonline.com/cost-saving-cancer-patients-life-analysis-celgenes-revlimid

Celgene.com. May 2015. “Celgene Patient Support for Revlimid” Web.  Retrieved from: http://www.celgenepatientsupport.com/revlimid-patient/

ClinicalTrials.gov. August 23, 2016.  “Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation.” Web.  Retrieved from: https://clinicaltrials.gov/ct2/show/NCT02492737

Drugs.com “Revlimid Prices, Coupons and Patient Assistance Programs.” August 8, 2016.   Web. Retrieved from:  https://www.drugs.com/price-guide/revlimid

Wikipedia. Lenalidomide (Revlimid).  August 24, 2016. Footnote 2, 2012.  Web.  Retrieved from: https://en.wikipedia.org/wiki/Lenalidomide

COUNTS DROP FOR UNKNOWN REASONS; TRANFUSION NEEDED JULY 21, 2016

I hate that I tend to blog only when there is a major change in Todd’s condition, but when he is feeling well, we are busy trying to enjoy life!  Unfortunately, it has been since May since I have provided and update, and once again the news warrants the update.

Todd’s condition on the trial drug AG-221 (Agios/Celgene) has been stable.  He hit end of the one year anniversary being on the medication on March 23, 2016.  He had a bit of allergy symptoms in early spring April/May 2016, with a runny nose, sneezing, cough, etc.  We attributed this to the fact that the grass was being mowed often and the spring was wet. 

He felt well enough to visit his brother Ted in St. Petersburg in mid-June, but he was still suffering from allergy symptoms.  He saw his Bone Marrow Transplant Doctor at Cleveland Clinic every month on Day 1 of his drug cycle, and continued to get blood work drawn locally on his Day 15.  The doctor gave him the “thumbs-up” on his June 13 visit to fly to Florida and back for the short visit. He came back still feeling symptomatic, mostly still suffering from a lingering cough. 

He was feeling somewhat tired, but was able to get around most of the day just fine, but with a nap (it isn’t unusual for him to need a nap). We had missed a family reunion in Tennessee in June and wanted to go down to visit the weekend of July 4.  I haven't had a vacation in over two years! He had blood work drawn before we went on Day 15 of Cycle 16, which was June 29, 2016.  Since it was drawn at a local lab, he didn’t get the results until we were driving down to Tennessee on July 1.  All of his counts had dropped.  This was the first time in many months that there had been a significant, noticeable drop in counts.  His Hemoglobin was down to 9.0, white counts to 3.2, ANCs at 2.5, and platelets at 65,000.  Just to give you some perspective, his Hemoglobin had been running in the 10s and 11s, Whites and ANCs in the 4s, and platelets as high as 75,000. 

This was a shock to us; this meant he was only 1 point  away (<8.0) from needing a blood transfusion!  He hasn’t needed a transfusion since he was sick with the pneumonia and cold last October 2015.  Even though his counts had starting dropping slightly before this, we were not concerned, because we all understand that there is often some slight variation from visit to visit and from one lab (Cleveland Clinic) to another (Local Compunet). So, we attributed the slight differences in the differences in labs.

We tried to make the most of our trip to Tennessee, however, we quickly noticed that Todd was getting tired very easy.  When we returned, he didn’t seem well rested and still had that nagging cough.  So I ended up emailing his trial nurse at Cleveland (so did he!) the next morning to let her know.  Todd’s trial appointment was already set for the upcoming Wednesday, July 13, 2016 for Day 1 of Cycle 17.  So, they set-up at Chest CT in addition to his bi-monthly bone marrow biopsy, Pentamidine breathing treatment, EKG, and Echo cardiogram.  

The doctor had asked extensively about his cough and some tightness he was having in his foot/ankle before she gave us the news about the low blood counts.  We both felt something was wrong, and knowing her well, felt she didn’t want to give us the bad news. Then she let the bomb drop; the blood work for that day was back and his hemoglobin had dropped even more:  Hemoglobin down to 8.1, Whites #, ANCs #, and Platelets.   Basically, the initial view of the CT scan looked fine, and she didn’t have any idea why the counts were dropping.  We discussed having Todd tested for CMV or Cytomeglavirus which can affect post-transplant and immune-compromised patients, but she was hesitant to this.  I knew why.  She wanted to wait to see what the results of his bone marrow biopsy were.  If the blast counts, were up, we would have our answer.  This scared us; the trial drug has been working so well!  She said that it was possible that he was sick with a virus, and that the only time his counts had dropped like this (on the trial drug) was last October when he had the cold and pneumonia.  So, the possibility that he was sick, was a good one.  We left a little deflated. 

They don’t transfuse Todd until his hemoglobin drops below 8 and it was already late when we got done with all his appointments.  There was no treatment appointment made to give him a transfusion while he was there.  We would have to follow-up with his local oncologist. We didn’t end up getting home from Cleveland that night until after 11:00 p.m.

So, the next day, Thursday, he was still very tired.  His trial nurse called in blood work orders to his local oncologist and he went in on Friday, July 15, 2016.  We also asked if they would go ahead and have the blood drawn for the CMV test.

Before I go on, I have to tell you about our ObamaCare health insurance nightmare.  We received a letter from our Healthcare provider, In Health Mutual, an Ohio PPO created after the Affordable Care Act was passed in June saying that they were going bankrupt and that if we didn’t want to lose our tax credit/subsidy we had to select a new health care provider by July 1, 2016!  So, Todd had to go back onto the Government Healthcare Marketplace website and try to find insurance that the Cleveland Clinic and his doctor accepted. He found one: An Anthem BC/BS Silver PPO program, which he selected.  We paid for the new premium for the Anthem and had the information for the new insurance before Todd’s appointment at Cleveland Clinic on July 13, 2016, only to find out that IN Health Mutual withdrew almost $1,000 from our checking for the July premium-even though we switched healthcare companies!  We spent hours trying to get it corrected and to get our money back.  The input operator at the Marketplace also accidentally cancelled our Dental Insurance, so, we had to cancel Todd and Abby’s dentist appointments for that week and try to get our Dental re-instated!

Here’s the kicker, we realized when Todd went into see the local oncologist’s PA to have more blood work on July 15, that they didn’t accept our new insurance!  Basically, we would have to pay that bill out-of-network!  This is already in addition starting over on our yearly deductibles half-way through the year, when we had already met our deductibles on the prior In Health Insurance!  

Now, back to Todd.  The blood work came out about the same, Hemoglobin was still at 8.1 and the platelets had gone up slightly, but the PA decided that Todd could wait to have a transfusion and sent him home.  I called the trial nurse that day and asked if the preliminary bone marrow results were back; that it would ease our minds to know the results.  She sent him the results and Thank God, the blasts were still only at 1%!  This was great news!  The cancer had not been ratcheting up, but something unknown then was causing the drop in counts. 

By Tuesday, July 19, 2016, Todd was still very tired and his cough still persisted.  The trial nurse sent orders to the lab, but no one there was certified to take blood from his port, only from his arm and by this time, his arm was getting bruised.  I knew we needed to have his blood drawn again, and something needed to be done about getting him a new hematologist/oncologist locally.  So, I started calling.  First, to the new insurance company, Anthem.  They gave me 2 or 3 names, but only two were actually hematologists.  I also asked about what hospitals in the area were covered because he had always gone to Miami Valley Hospital in Dayton for all of his transfusions.  I found out that Miami Valley was no longer on our list!  Only the Kettering Medical Network of hospitals.  I was upset at first, not sure if any other hospital had their own blood bank nearby.  I also asked Anthem if Cleveland Clinic and Dr. Hamilton was covered and she said no!  I wanted to throw-up in my trash can I was so upset! So, I called the Government Healthcare Marketplace back and they said both were listed as providers! 

I called Dr. Amanda Laubenthal of Cancer Specialist of Greater Dayton.  They were very nice and I began to relax. They had an office in Beavercreek near Soin Medical Center, just minutes from our house.  The doctor was willing to see him right away, but they needed his medical records (at least his recent reports).  So, I called his trial nurse and Cleveland and she was able to send them electronically before we got off the phone!  She also told me that the CMV test had come back negative.  So, one more thing we could rule out!  Dr. Laubenthal’s office contacted Todd and he had an appointment to see the doctor and get blood work for Wednesday afternoon, July 20, 2016.  I was so relieved!  I didn’t get to go with him to the appointment that day because I had to work, but he liked the doctor and the blood work showed that his hemoglobin had dropped to 7.5, whites to 2.2, ANCs to 1.7, and platelets to 66,000.

At first he told me over the phone that he wasn’t going to get a transfusion even though his hemoglobin was under 8.0.  He was just going to “monitor himself” and get blood work next Wednesday!  I was livid!  I tried to convince him that he would likely feel worse and that come the weekend, he wouldn’t be able to get a transfusion and would have to wait until the following Monday to get in.  I didn’t understand why he was so opposed to getting transfused.  He told me he was going to go to SAMS Club to pick up some things we needed.  In about half an hour later, he texted me and said he was going to go back to the Dr. Office/hospital to get “type and screened” for a transfusion.  They had just closed the office, but lucky for him they let him come in and by 5:00 p.m. they had set up an appointment for a transfusion of 2 units of blood at Soin Medical Center for the next morning, July 21, 2016. I’m not entirely sure what made him change his mind so quickly, but if I had to guess, I would say that once he got to SAMS Club and had to walk so much, he realized how exhausted he was and that he had better go get the transfusion!  I knew he was stubborn, but… Anyway, I was just grateful that he changed his mind.

I had to work the next day, but I took a long lunch to go check on him during the transfusion.  I told Todd to make sure the blood they gave him for the transfusion was “Irradiated and Leucocyte-reduced, and CMV negative.”  He asked, and they assured him the first unit they were giving him was.  When I got there, they were just finishing the first unit of blood and getting ready for the second unit.  While they were getting it ready, I asked if it was Irradiated, Leukocyte-reduced, and CMV Negative, but they couldn’t find it labeled anywhere on this unit that it was CMV Negative.  So, I asked them to wait and ask someone.  This is a bit technical, but basically, people who have caught CMV (the virus that can cause Herpes) produce antibodies to fight against it.  Once you have been exposed to CMV, it can stay in your system forever, even if it stays dormant.  So, if the antibodies are present in the blood, then they know the donor has been exposed to the CMV.  We had just confirmed that Todd didn’t have CMV, nor did we want him to get it, so I wanted to be careful.  Most of the time, if the blood is irradiated it kills most germs or viruses.  In addition, if it is leukocyte-reduced, it means that they have tried to take out most of the white blood cells, where viruses like CMV reside.  This is likely good enough, but I knew that since they were able to screen for it now, and since the first unit was CMV negative, why shouldn’t the second unit of blood be?

So, they halted the transfusion and waited from word from the blood bank and the local oncologist.  Meanwhile, I called Dr. Hamilton, his Bone marrow transplant Doctor in Cleveland and his trial nurse to ask.  I got patched through to Dr. Hamilton and she said it would likely be ok, however, Dr. Laubenthal said No, just order new unit of blood that was marked CMV negative.  So, luckily Soin had more blood on stand-by and Todd only had to wait another 30 minutes for them to get the second unit of blood and start the transfusion back up.

I was glad though that I had a chance to talk to Dr. Hamilton, who said she was at a loss for what was causing the drop in counts since the bone marrow blast counts were low and the CMV test came back negative.  They were trying to come up with other possibilities and decided that he should be tested for RSV.  So, they contacted Dr. Laubenthal's office and had the nurses collect a sample (through the nose) while he was there.  The transfusion was long as usual, but helpful.  

I know medicine is a process of elimination, but it can be frustrating not knowing what is causing the drop in counts, even though all the tests for various viruses having been coming back negative, which is good.  The alternative of it not being an illness or virus of some sort, is too upsetting to contemplate at this point.  

He is scheduled to have blood work done for his Day 15, Cycle 17 done on Wednesday, July 27, 2016.  So, we are going to see how much this transfusion helped, get the results back from the RSV swab, and go from there.

We appreciate your prayers and support as always.


WANT MORE INFORMATION:
Cytomeglaviru (CMV)s: http://www.mayoclinic.org/diseases-conditions/cmv/basics/definition/con-20029514

RSV:
https://www.cdc.gov/rsv/
http://www.mayoclinic.org/diseases-conditions/cmv/basics/definition/con-20029514

One Year on AG-221 Trial Drug

As of March 23, 2016, Todd has been taking the trial drug AG-221 for one year!  It's hard to believe how precarious Todd's health was this time last year: getting blood transfusions every 6-12 days; having no immune system (no ANCs and no White Blood Cells); and having no energy-barely able to get out of bed.  Today, one year later his counts are good (for him)!  The disease, while still present, has not proliferated, and his cancerous blast counts are low!  Besides being in remission, we couldn't ask for anything more!

To give you an idea, here is a comparison of the differences in his counts from last year to now:

Year:                2015                          2016

Whites:                 .2                            3.99
Hemoglobin:       7.3                          11.8
ANCS:                   0                           3.15
Platelets:       70,000                       57,000


As you can see, he has had a remarkable increase in his White count, Hemoglobin, and ANCs.  His platelets vary now between 55,000-75,000, which is about the same as they were a year ago.  His platelets have not responded as well. In trial terminology this is considered as a hematological response without platelet recovery.  That being said, his platelets are still high enough to prevent any serious bruising or the need for transfusions (usually when platelets fall below 10,000). 

After not hearing back from the drug company whether Todd could only go once a month for his trial visits as promised, I finally sent a message to his bone marrow transplant doctor telling her that we were unhappy with how the administration of the trial has been going.  We haven't received any financial reimbursements for months, none of our appointments have been made ahead of time like they should be, and when they have been scheduled, they have been for inconvenient times  (8:30 a.m. when they know we have almost a 4 hour drive to get there).  I "offered" to go straight to the Principal Investigator at Cleveland Clinic or the Drug Company itself, but the doctor finally got confirmation that Todd no longer needs to go to the Cleveland Clinic for his Day 15 appointments just to get blood work done.  They have arranged for Todd to have his Day 15 blood work at our local Compunet Lab.  This means he will only  need to go to the Cleveland Clinic on his Day 1 appointments, only once per month!  What a relief!  No more driving up to Cleveland every two weeks!  I'm so grateful! As to the appointments and reimbursements: they are short-staffed and trying to hire more help.

In other news, we just received his preliminary bone marrow results from his latest biopsy from March 23, 2016:

Results: "Persistent Myelodysplastic Syndrome.  Hypercellular Marrow (90%) with Trilineage Hematopoiesis, Erythroid Hyperplasia, Multilineage Dysplasia and 2% Blasts.  Increased Iron Stores and Increased Ring Sideroblasts. Mild Microcytic Anemia, Thrombocytopenia and Absolute Lymphopenia."

This is a long way to say that he has 2% cancer blasts in the marrow, which is Low! And he is still mildly anemic and all three of his blood counts: white, red, and platelets are low.  We haven't received the latest cytogenics back yet, but the prior biopsies have not shown any major changes.  They still show he has complex chromosomal mutations, but no new additional mutations.

With all this good news we should be on an emotional high-right?  Unfortunately, we are not.  There are still other complications in our lives right now, that we are not able to fully enjoy these blessings to the fullest.  First, Todd has been suffering from persistent diarrhea.  He can't seem to eat anything, without immediately having diarrhea (no fun).  He isn't dehydrated, but it is starting to wear on him.  We  have discussed the issue with the doctor at the last visit, and they have called in lab orders for Todd to bring in a stool sample (which he isn't real motivated to do-who would?). 

Second, I still have not been able to find a full-time job.  It hasn't been for the lack of trying. I put in about 5 job applications per week, which is very time consuming, because everything has to be done online and some places require mandatory personality testing, etc.   My friends have been diligent in helping me find postings, but I don't have anyone who can help me get my foot in the door anywhere!  I've been substitute teaching about 2-3 days a week, and spending some time volunteering at Wright State University Libraries in their Digital Services Department, where I am working on a project.  Never have I experienced such a depressing cycle: applying, following-up, and receiving some type of rejection notice.  Not only is it wearing on me, but it is wearing on Todd, who also feels helpless that he can't work, and that I have to go through this.  (He has always been the bread-winner and has faithfully provided for our family; now, he is so limited and cannot work because of the cancer).  After I fill out applications, I feel so encouraged and confident that I can do the job!  But, weeks later, disappoint sets in when I learn I didn't get the job.  I just don't know what it takes...

Third, we are considering selling the house again.  We have half-heartedly put the for sale by owner sign back out in the yard, but nothing else.  It is not enough to get us the attention we need, so we need to consider getting back online for sale, or hiring a realtor to list it.  The process of having the house ready to show all the time and the thought of moving is so stressful, that this really needs to be a last resort option once again.

Lastly, we both feel like a lot of circumstances are out of our hands.  I am doing all I can, he is doing all he can, but its not enough to get us where we need to be.  This has led to moments of despair for both of us, at least temporarily.  Then, we both come around to putting things back into perspective!  His health is better than it has been in a long time, I am healthy, the kids are healthy, we have a roof over our head, and food on the table!  God is good! 

Prayer requests and needs:

Please pray that I can find a full-time job soon.  I have one prospective meeting next week, and one job interview at Target, but I fear that they will not be hiring full-time nor above minimum wage.  I have about two more months in which I can substitute teach, then school will be out for the summer.  Abby and Lewis have begun looking for summer jobs too, as college classes will let out in a few months.

Please pray we can get answers to Todd's persistent diarrhea and that it will subside.
Pray for encouragement!  And as always, with me working and volunteering as much as possible, Todd is home alone.  He sleeps pretty late each morning, but I'm sure he would welcome a lunch invitation or just having some company. 

Praises and shout-outs:  Thanks to Chris and Jessica White for raising our spirits by taking us out to eat and then hanging out with us!  To Gary Johnson, for helping Todd get the snow throwing attachment off and installing the mower blade onto our Zero-turn lawn mower.  Now we can mow our own grass instead of paying someone to do it (which will save us money).  Todd has already started training Ellie on how to mow the grass!  To Vicki Kennedy and Dana Johns who are forever looking for job postings and sending them to me!  You both are so helpful!  To my friend Darsie Wohler for getting me out of the house one day for lunch and some girl talk!  And to Pastor Chuck Moore, who faithfully stays in touch with us so he can pray for our needs.

Seeing Early Results within 5 Days of Starting Trial Drug

Todd holds up the AG-221 Trial Study Drug

We are so excited that Todd finally got to start the Trial Drug AG-221 on Monday, April 20, 2015, at the Cleveland Clinic. We had to be there from Sunday night April 19, through Thursday morning, April 23.  My mom graciously stayed with the kids.  Monday was a long day, beginning with testing at 7:15 a.m.  He took the first dose of the drug:  200 mg or 2- 100 mg tablets with food  around 9:00 a.m. with hourly tests of EKGs and blood draws for 10 hours beginning shortly after.  His blood counts were low that day with his hemoglobin at 7.6; whites .47; platelets 34,000; and ANCs/neutrophils too low to count.  So, once they checked the protocol to make sure it was alright to give him blood during the testing, they ordered him two units of blood to be transfused while he was there.  We finished that day around 7:00 p.m.

The next morning, Tuesday, April 21, we had to be there around 8:30 a.m. for lab work and testing.  No drug was given this day.  The protocol called for one dose on Day -3, which was Monday, then to do testing and evaluations for the next 72 hours.  So, we had to go back Wednesday for another easy day of morning testing and no medication.  Thursday, April 22, 2015 (my mom's birthday!) was considered the official first day or Day 1 of the trial drug.  It too was a relatively easy day.  We were able to finish up early and head home.  For all the months and preparation leading up to beginning the trial, three out of the four days we were relatively uneventful!

Overall, we are pleased with how everything went at Cleveland Clinic.  Todd got to see his bone marrow transplant doctor on Monday and Thursday.  I love the research nurses Ashley, Samantha, and Chad.  They were very good to us.  The Cleveland Clinic was able to fund our hotel stay for this initial visit at a nearby hotel between downtown Cleveland and the Clinic; mainly because we were on the waiting list for the Hope Lodge, but were unable to get in.   We were able to submit travel expenses including Todd's meals and gas/mileage for reimbursement.  On all other trips, we have to pay for our hotel stay, unless a room becomes available at the Hope Lodge, but we can submit those expenses also.  God continues to provide for us!

While we were there, we visited our friend Rick, from the Transplant Floor.  He had been admitted to the Leukemia floor trying to fight his relapsed AML since March.  The chemo has taken the toll on him.  His hands and feet were peeling and yellow from jaundice.  He wasn't as responsive like normal. He has a bowel blockage and hasn't been able to eat solid foods; unfortunately, he can't control his bowels at all, they believe that is also a side-effect of the additional chemo.  He has to have platelets and blood transfusions every day!  They are also giving him potassium for his brain.
As a follow-up, I talked his wife on Wednesday, April 29, and they were in the process of moving him to hospice closer to home.  The doctor said he may have 2 weeks to 2 months to live.  He has 50% blast cells in his blood stream, and does not have the same gene mutation Todd does, which makes him ineligible for AG221 drug study.  Please pray for him in his last days and for his family as they go through this difficult time.  

Todd had to have routine blood work done on the following Monday, April 27, 2015.  We were afraid he was going to need a transfusion, because he had been feeling fatigued the day before and spent most of the day in the bed resting.  To our surprise, his numbers were good!  He needed no transfusion since his hemoglobin count was at 8.8. His white count went up to 1.0 which hasn't been that high in weeks or months! His neutrophils were still low at .700, but at least he was above the neutropenia threshold of .500 and his platelets were at 60,000! We were praising God for these very early results. He had only taken 5 doses of the trial drug by this day and we want to believe that the increase was the result of the medication beginning to work.

The weekend we got back home, we started working on the house again, trying to get it ready to sell.  We both worked a little too hard and too much, but not without help.  That day, I had my good friend Dana come over and she went to work on helping clean out my bedroom closet, so it didn't look cramped or cluttered.  We got a lot done! Monday, I spent finishing cleaning the closet and taping up boxes and moving them out to the garage with the help of my good friend Darsie.  Tuesday, we were blessed with the help of our great friends Chris and Lynda; the guys worked outside in the yard and Lynda and I cleaned and straightened up the Piano Room and Dining Room.  We got so much done! 

In addition to working on the house, we have been selling our furniture and other items as we go.  I take photos and then we post the items online and usually spend the next day or two taking emails, texts, calls, and arranging pick-up times.  This has been a good strategy, since we are getting things removed now before showing the house and before I attempt a garage sale (which is so much work in relation to how little people are willing to pay). 

By Wednesday we needed a break! We had to pack for our trip to The Cleveland Clinic, but at least I was able to help Ellie pack up some keepsakes in her room before leaving late that night.   Thanks to Todd's mom Ann and our former neighbors Joni and Raymond, for all the boxes and packing materials!

We arrived around in Cleveland around 11 pm last night and hit the bed, since we had to be at the hospital the this morning, Thursday, April 30 before 7:30 a.m.  The day's appointments went well.  Todd saw his doctor and the research nurses got busy asking their questions, doing the EKG and blood work for the trial study.  He was scheduled to have a transfusion today if his hemoglobin was below 8.5, but we learned that it was at exactly 8.5, so everyone was in agreement that since Todd was feeling pretty good, they were going to hold off on transfusing him for today.  The rest of his numbers were down slightly, his whites went down to .830; his platelets down to 41,000; and the nurse contacted us later with the other numbers, namely his neutrophils, which have dropped to .530 making his nearly neutropenic again.

What's Next?
He is scheduled for routine blood work every Monday at the local oncologist's office, so we will see how his counts are on Monday, May 4, 2015.  If he needs transfused, the local oncologist will make arrangements for him at Miami Valley  Hospital before his next appointment at the Cleveland Clinic on Thursday, May 7, 2015.  This is going to be another long day of tests, because it is Day 15, or about the half-way point of the Cycle 1 of his drug trial.  In addition to hourly blood draws for 10 hours, he will have EKGs, and a bone marrow biopsy (his 15th? I think, he has had so many, I have lost count). They have also scheduled a treatment appointment for transfusion, if he hasn't had one by then and needs one. The protocol of taking the drug with food will also change at this point.  Instead, he will have to fast for 2 hours before taking his scheduled dose at 9:00 a.m. and then wait for 1 hour after taking it before he can eat.

The only concern so far is his bilirubin levels, which were elevated, however, even this is expected in the beginning.  The research nurse assured me that these levels typically come down as time goes on.  They are not concerned about these levels because his liver numbers and the direct bilirubin numbers both looked good.  They only thing that I noticed today, was a slight yellowing in the corners of his eyes; the nurse agreed that there was a slight bit of yellowing, but that this is a known side-effect of the drug.  If it gets too high, they will interrupt the dose or decrease it, but that his current levels are no where near needing any of those adjustments now.

On a personal note, we will continue to work on getting our house ready to sell.  Which means, I will be enlisting another round of volunteers to help me inside get things de-cluttered and cleaned for showing.  Todd won't need much more help outdoors, but mainly indoors, with a bit of painting projects, changing light bulbs inside and outside (some days I don't want him on a ladder), and repairing a bit of drywall.  Tomorrow, I'm going to help our oldest daughter Abby finish moving things out of her dorm room.  I can't believe she is done with her Freshman Year of college already!  I need to work on preparing a graduation party for Hannah Lewis, including buying decorations, ordering food, etc.  Ellie's last club volleyball tournament is this Saturday: yahoo!  And track season should be ending soon too.

Please pray: 

• That we can get our house on the market in about two weeks.  The market is still hot and we can't really buy or write a contract on anything til we have ours sold.
• That Abby and Hannah Lewis find jobs soon.
• That I can get get the majority of packing and selling done before I start summer classes in June.  I also have to turn in my application for a fall practicum by June 6 or so, and I don't have one lined up yet.  If I can't do this, I won't be able to graduate by the end of the year. 
• Continued improvement of Todd's health and stamina; namely, that the drug will begin to help his counts go up and the need for transfusions go down.
• Family issues and dynamics as we continue to undergo weekly family counseling
• That the transition of moving to go smoothly.  That God would open and close doors: find the right buyer for our house and the right house for us to buy.  We have been struggling to find  a house that isn't too big or too small that will give us enough financial breathing room while Todd is on disability and I finish my degree.  The physical demands of moving and the emotions of giving up our home and most of our belongings is traumatic, even though we understand they are just material.  This is the only home Ellie has really known and both of her siblings will be gone at college this fall; all this will be a big adjustment for her. 

As you can tell, there is just so much uncertainty in our future.  We are doing our best to take things a day at a time, but with such upheavals and the constant concern for Todd's health, me and the kids are feeling a bit anxious and emotional. (Not Todd, he is in a different place than we are!). We understand the wisdom of asking God to give us just what we need for that day, and not to worry or be anxious about everything else, but we need reminded!  We also understand that we need to take these feelings to God through prayer and that he will supply all of our needs.  Please pray with us.

As always, we appreciate your love and outpouring of concern and support.  It means so much, to see our friends and family helping us through all of this day by day.