Cycle 6 Results

I called Kathy Colson today to get the final results for Cycle 6 of my MLN9708 protocol.  As I expected, everything was the same as Cycle 5, with no M Spike and no monoclonal gammopathy detected in the blood serum immunofixation.  The urine immunofixation was also the same as last month, with the reading "cannot rule out small monoclonal protein".  It appears that I may have achieved a plateau in my response to the treatment.

I won't know if I have actually achieved Complete Response (CR) or even better, stringent Complete Response (sCR) until I have my bone marrow biopsy, which is scheduled for Feb. 15.  (Ouch!)  If there is more than 5% clonal plasma in the marrow, then I have achieved Very Good Partial Response (VGPR).  If there is less than 5% clonal plasma in the marrow, then I have achieved CR.  If no clonal plasma at all is present in the marrow, then I have achieved sCR.  In any case, I am fortunate to have responded so well to the treatment so far.  Kathy is very pleased with my response and she is very excited about how well this MLN9708 has been working for everyone in the clinical trial.  She reminded me again about my good fortune to have the initials WO (thanks, Mom and Dad, for naming me William), which allowed me to slip into this trial.  Hard to believe!

I learned something new from Dr. Richardson on Wednesday.  As you know, my form of MM is classified as IgA Kappa, involving the monoclonal IgA heavy chain gamma globulin coupled with the Kappa light chain.  The most common form of MM is IgG.  Dr. Richardson informed me that the IgA form is more aggressive than the IgG form, which is another reason he is recommending doing the stem cell transplant early rather than waiting until relapse.  That's two strikes I have against me now:  an aggressive IgA type of MM and the t(4;14) chromosome abnormality.  I guess I need to knock this thing down as hard and fast as I can.

My Autologous Stem Cell Transplant (ASCT) will be performed at Brigham and Women's Hospital (BWH). Muriel told us that they do about 150 transplants a year there.  I have had some concerns about another three-letter acronym:  TRM (Transplant Related Mortality).  Some literature I had read quoted mortality rates of up to 4-5% from complications of the transplant process itself.  That seemed a bit high to me.  Muriel told us last Wednedsday that the TRM at BWH is about 0.5%.  That's comforting!

I now have a complete nominal schedule for the stem cell collection and transplant process, assuming I proceed immediately from collection to transplant.  As you know, I have been considering the possibility of deferring the ASCT for a month or so to continue the MLN9708 protocol if I continue to show improvement each cycle.  Gretchen is not happy with this approach, feeling that I am trying to over-analyze and over-control this, and that now is the time to just do it.  I'm thinking that perhaps she is right.  The uncertainty of waiting and seeing is pretty stressful and makes it difficult to do any planning.  Muriel also told us on Wednesday that the transplant clinical trial protocol I just signed up for may require me to go directly to transplant after the stem cell collection.  That, coupled with the fact that I do appear to have achieved a maximum response to the medication to date, seems to validate just going ahead with it now.  So unless Dr. Richardson has a different view, I think there is no reason to delay any further.  We will be meeting with Muriel this Wednesday for an information session.  Perhaps we will make the final decision then.

Here is my current schedule:

Feb. 15:  Pretesting, including pulmonary function, skeletal survey, echocardiogram, bone marrow biopsy
Feb. 28: Pretesting, including Vein check assessment, EKG, Social Worker consult
Mar. 2:  Stem cell mobilization with Cytoxan (cyclophosphomide) chemotherapy
Mar. 3:  Begin 10-day oral antibiotic Levaquin
Mar. 4:  Begin 9-day Neupogen granulocyte-colony stimulating factor (G-CSF) injections (may do at home with Gretchen's help)
Mar. 8:  CBC/diff blood test
Mar. 12:  Insert Hickman central line catheter
Mar. 13-14:  Stem cell collection (out patient at DFCI)
Mar. 17:  Admit to BWH
Mar. 18-19:  Melphalin chemotherapy
Mar. 20:  Stem Cell infusion
Mar. 21-Apr. 4:  In-patient recovery (visitors allowed and encouraged..hint hint)

Notice how they have graciously allowed me time for my golf vacation from Feb. 18-25 at Ocean Isle Beach, NC.  How accommodating is that?!  I damn well intend to enjoy it!

Cycle 7 Day 1

Claudia, Paul, and me

Jeffrey came with us on Wednesday to meet with my medical team, and he took this picture.  As I mentioned before, I am no longer getting financial assistance on my Revlimid prescription.  That hit home when I had to shell out a $2,800 co-payment for this month's prescription!  It could have been worse, since the full price for a 21-day supply is about $8,000.  Thank goodness for my Medicare Part D prescription drug coverage.  I'm flying through the so-called 'donut hole' in Medicare coverage, and I am almost in the catastrophic category already, after which I will pay only 5% of the drug costs for the rest of the year.  That's a good thing, for I have a feeling I'm going to be getting lots of expensive medications in the months to come.

I think the side effects of these drugs are starting to get to me a little bit.   The dexamethasone is messing up my sleep patterns so it's hard to tell day from night.  I didn't feel great yesterday, so I spent most of the day resting.  I also found out from Richardson on Wednesday that my diarrhea may also be from the Revlimid, technically denoted as "Revy Belly".  It's nice to have a name for it.  I got a prescription for Colestipol to take next week to help keep it from recurring.

Now that my dental issues have been resolved, I finally got my first IV infusion of the bisphosphonate Zometa on Wednesday.   This should help protect my bones against the ravages of MM.  I have been very fortunate so far to have escaped any serious bone involvement.  I think I am supposed to take Zometa on a monthly basis going forward.

I finally made the decision to go ahead with the ASCT, so I signed the consent forms for the transplant clinical trial.  After this current Cycle 7, things get pretty hectic.  I go through some pretesting later this month, and then on March 2, I start the stem cell collection process.  According to the current schedule, I will go into Brigham and Women's Hospital on March 17 (Happy St. Patrick's Day!) for the stem cell infusion. I will probably spend about 18 days in the hospital if all goes well.  There is a possibility that I may delay the transplant another month or so and go back on the MLN9708 for another cycle or two if I am still responding to the treatment, but the most likely scenario is for me to go directly to the ASCT.  I'd better enjoy life for the next month, because I won't enjoy it much for a while after that.  

Arizona Trip

I apologize for the long absence from blogging while we were away, but there has been nothing dramatic to report on the medical front.  However, I haven't been feeling too well off-and-on lately, with recurring bouts of diarrhea.  The day we were to leave for Arizona was one of those days, and I contemplated calling Dr. Paba-Prada for advice before we left.  However, I recalled the strategy often used by my good friend, Bob, over the years, whose mantra was, "I'd rather ask for forgiveness than permission".  We went as scheduled, and it turned out to be the right decision.  Fortunately, by the next day I felt fine, and we had a great time in Scottsdale, AZ.  The symptoms did return, but after a subsequent call to Paba-Prada, she suggested Imodium OTC (that's Over the Counter for those of you who are averse to TLAs), and it has been under control since.

Cardinal rule of diarrhea:  Never, ever contemplate farting.

While in Scottsdale, we attended the Barrett-Jackson car show/auction.  What a hoot that was!  The picture is of a 2012 Lamborghini Aventador, which lists for $425,000.  However, the Penske rep informed me that there is a 2-3 year wait list and the final price will be $600-700K!  There were some great old cars, and watching the auction was a lot of fun...Gretchen even enjoyed it.

We then headed up to Sedona, AZ on Saturday.  What a beautiful spot!  Aside from its incomparable beauty, Sedona is noted for its spiritual connections and vortexes (I will refrain from using the plural 'vortices' to avoid appearing pedantic).  We hiked to the Boynton Canyon Vortex.  Gretchen felt the energy from the vortex immediately.  As for me...nada, zilch. nothing.  I must be spiritually challenged.  It was nice and peaceful though.  

We bought a book from an MIT grad purporting to give a scientific explanation of the vortexes.  After reading some mumbo jumbo about string theory and 10 dimensions, I didn't feel any further enlightened.  However, something seems to go on around them.  The Juniper trees in the vicinity of vortexes grow with twisted trunks and limbs, a phenomenon we were told doesn't happen any place else.  Here is a picture of the "twisted sisters", two junipers near two of the vortexes.  We saw these on our Broken Arrow Pink Jeep tour, which we highly recommend if you visit Sedona.

While in Sedona, we visited a Bhuddist Stupa or shrine.  One is supposed to walk around it three times clockwise while meditating or offering prayers.  Gretchen, who cheerfully admits to being somewhat dyslexic, started in the wrong direction.  I quickly turned her around before she could undo an untold amount of goodwill at the site.  ;-)  There were hundreds of prayer flags around the Stupa, and I noticed one of them with some writing on it.  As I looked closer, it said, "I pray for those with cancer and other illnesses, that they may be healed".  Wow!

We had a wonderful trip.  It was a relaxing and renewing getaway, well-timed to prepare us for the uncertainties and rocky road of stem cell transplantation that we may about to encounter.

Transplants and Finance

Yesterday, Pat Killingsworth's blog referenced an article about him and Autologous Stem Cell Transplants (ASCT) that recently appeared in Nature Magazine.  It's an interesting piece, which addresses most of the issues I am now currently facing in making my decision on which way to go.  Here is a link to the article:

http://www.nature.com/nature/journal/v480/n7377_supp/full/480S46a.html

There is a good discussion on the question of early versus delayed ASCT.  Here is a quote from the article:

"Opinion is divided on the best treatment. Some myeloma specialists favour an aggressive treatment tactic, in which transplants are administered soon after diagnosis, when the disease is thought to be at its most vulnerable. Others opt for a milder protocol that reserves the hard-hitting transplant option — with its attendant risks of infection, bleeding and anaemia — as a last line of defence if less toxic therapies fail."

It will be years before enough data are collected to resolve this question.  In the meantime, it is up to the individual patient (that would be me) to try to figure out which way to go.  Would somebody please hand me a crystal ball?  It's like I'm playing Blackjack with all my chips in, trying to decide whether to hit or stand holding a hard 12 with the dealer showing a 3 or a 4.  For my MM situation, I see the dealer with a 3, so "Hit Me"!  (Unfortunate phrasing, perhaps?)

Last year, I was fortunate to receive a stipend from Good Days of the Chronic Disease Fund to defray the exorbitant costs of my Revlimid prescriptions.  As a result, I only had a $20 co-payment every month.  I have been very lucky!  However, I just found out that my application for 2012 was rejected, as I don't meet their financial criteria.  Oh well.  I can't wait to see how much I will owe when I pick up my prescription next week. 

You may notice the time on this post.  Yes, it's oh-dark-thirty!  I've had some issues dealing with the dexamethasone this past week.  Thursday night, I couldn't sleep at all, as I was in what one patient has dubbed my "dexametha-zone".  By Sunday, after tailgating and attending the Patriots/Broncos playoff game on Saturday night (Go Pats!), I finally crashed and caught up...so much so that now I can't sleep again.  Aaarghhh!

We leave for our Arizona vacation on Wednesday, so I may not be posting any updates for the next week or so.  We'll be back in time to meet with Dr. Richardson on Jan. 25.

Transplant Thoughts

I was reading Pat Killingsworth's latest article in this week's Myeloma Beacon, and one of the comments was from a newly-diagnosed MM patient in New York named Mike.  He had just progressed from Smoldering Myeloma to the real deal, and had decided to sign up for the MLN9708 clinical trial.  Naturally, he was scared and confused, so I reached out to him to tell him I was in his same situation 6 months ago and to support his decision to take this route.  He emailed me back saying he got a second opinion from Ken Anderson at DFCI (good choice!), who agreed with his doctor's recommendation to enroll in the trial.  I let him know how well I am doing and hope the same for him.  I hope he keeps in touch.  I'd really like to know how things work out for him.

Pat Killingsworth's new book, Stem Cell Transplants from a Patient's Perspective, just got published.  I got an email from him saying that pre-release copies are available, so I ordered one.  It came today, so Gretchen and I started reading it.  It's a bit discouraging knowing that Pat's transplant didn't work, although I think I'm in a much better situation going into this than he was.  If Pat's experience is any guide, I'm in for quite a ride.

It is slowly dawning on me what a big deal this whole procedure really is.  I scanned through the information guide book we got from DFCI on transplants.  I was struck by the amount of attention given to the importance of the caregiver, how difficult this will be both physically and emotionally, the need for a clinical social worker as an active part of the care team, and the numerous side effects, not to mention the weeks and months of recovery time.

In order to kill off all the bad myeloma cells, I will be given the chemotherapy agent, melphalan, prior to transplant.  This is a nitrogen-mustard compound, similar to mustard gas used as a chemical warfare agent in World War I.  Nice!  Just like Revlimid is derived from thalidomide, which many of you of a certain age will remember caused deaths and birth defects in babies back in the early Sixties.  I guess if these agents are good enough to kill people and maim babies, they're good enough for me take for my MM. 

Why am I considering doing this again?

We will be meeting with Dr. Richardson in two weeks, the day after we return from our week's vacation in Arizona.  I'm already compiling a mental list of questions and concerns to discuss with him then.  How are the other MLN9708 clinical trial patients doing?  How many of them have opted for a transplant?  Do I have to do the transplant immediately after stem cell collection if I sign up for this new clinical trial?  How many more cycles of the MLN protocol might make sense, if any? This is just a start.

We went out for Sunday dinner with friends of ours, Barbara and Andy.  Andy commented on my blog by noting that I am wont to sprinkle a plethora of TLAs throughout my posts...Three Letter Acronyms.  I plead guilty.  I will try to make it easier on you in the future by either spelling things out or reminding you of the definitions as I go along.  All the literature on this stuff fairly bristles with TLAs, so it's easy to get caught up in the madness.

Cycle 5 Results

Usually I'm all atwitter when my monthly protein test results come in.  I get most of my blood test results online through the DFCI Patient Gateway, but the most important monthly pathology reports, the serum protein electrophoresis and immunofixation interpretations, aren't available online.  Usually I call Kathy Colson at the beginning of the week after the test and have her read the results to me over the phone.  This time I didn't bother with that for a couple of reasons.  First, she's busy and I hate to keep bugging her, and second, I've already reached near Complete Response (nCR), and I've supposedly maxed out on the MLN9708 therapy after 4 cycles, as I mentioned in my last post.

Today I went in for my weekly blood draw and infusion treatment.  Heather was out today, so I had a new nurse, Jennifer.  I asked her to print out the Cycle 5 pathology report for me.  When Jennifer handed me the printout, I quickly scanned to the bottom of the page where the clinical interpretation is given.  Under Immunofixation, three words jumped out at me:  "No monoclonal gammopathy"!  I was stunned.  The test now shows no evidence of the myeloma in my blood.  Against all odds, I have continued to show improvement this last month, and I might possibly have achieved a state of Complete Response (CR)!  I have to admit I got a bit emotional at that point.  I had very low expectations for these results, and I was happy enough to have achieved nCR from my treatment so far.  This was totally unexpected.  I'm sorry Heather wasn't there today to share in my good news.  I don't know if there is a cloud 10, but I happily climbed onto cloud 9.

I have to add a note of caution here.  The internationally accepted criteria for achieving CR consists of all of the following:

• Negative blood serum immunofixation
• Negative 24-hour urine immunofixation
• Less than 5% plasma cells in bone marrow

As of my latest results, I now satisfy the first criterion.  In November (Cycle 4), my urine test results showed "small monoclonal kappa in gamma fraction".  The new Cycle 5 urine immunofixation result is "cannot rule out small monoclonal protein".  I'm happy to note that this result also shows a definite improvement (yippee!), but it's not yet definitive.  As for the bone marrow plasma, I need a bone marrow biopsy to measure that, which I won't be getting for a couple of months (it's no fun, so I can wait).  As a reference, my last bone marrow biopsy in August showed greater than 60% plasma cells in my marrow.  The important thing here is that I am continuing to respond well to my MLN9708 therapy, and if I am not yet in CR, I am certainly moving closer to getting there.  It's all good.

Now this is usually the point where I pull out the spreadsheet and show how all my numbers have evolved since I started therapy.  I'm not going to do that this time, since I know it makes your eyes glaze over.  It even makes my eyes glaze over, so I'll forgo that for all of our sakes.  There's no need to gild the lily here.

I don't know what all this means regarding my decision whether or not to undergo an Autologous Stem Cell Transplant (ASCT).  On the one hand, my continued improvement with the clinical trial protocol might mean an extended Progression Free Survival (PFS) by continuing with the protocol and deferring the ASCT.  However, an improved response to initial induction therapy also bodes well for an extended PFS after a transplant.  In other words, achieving CS gives better prospects for both options, but it doesn't necessarily favor one option over the other.  I will still continue to gather data and ask questions over the next couple of months, but as of now, I don't see any reason to change my opinion on how to proceed from here.

Pat Killingsworth just published his second book, Stem Cell Transplants, which he wrote from a patient's perspective.  I just ordered an advanced copy from him, which I hope will give some insights on what to expect with my potential ASCT.  I already have a detailed manual from DFCI giving the clinical perspective on the transplant process, which Gretchen and I will both read soon, but it will be nice to have the patient's side of this to mull over as well.

I have to say, the New Year has gotten off to a good start!