COVID Gap

Since my positive COVID test on December 14, I have been exiled from Dana Farber until January. Since then, I have been wearing the badge of dishonor and shame.

I wasn't really sick, mostly just tired and lethargic. After a few days, I felt better, but to my dismay, I still tested positive for COVID on December 21. I had no choice but to cancel my Christmas lunch that day with my good friends and business associates, Bahar and Dave. I hope to reschedule that soon. 

A family Christmas get-together was planned at my son, Jeff's, place, so I took another COVID test on Christmas morning. It was still positive! This was a dilemma. What to do? After checking with the family, I decided to go to our Christmas gathering wearing a mask and practicing social distancing. It turned out great, and we all had a good time. 

As the week wore on, I was feeling guilty and wondered whether I had infected anyone with COVID on Christmas. So I texted everyone on Friday. What I discovered was that almost everyone wasn't feeling well, but no one said that they had COVID! I thought there might be one of two reasons for this: either they didn't want to let me know because they knew I would feel terrible, or they didn't really care whether they had COVID or not. 

I'm beginning to think it might be the second reason. Nobody takes a test to find out whether they have the flu or a bad cold. They just deal with it until they get better. I think it's becoming the same with COVID. Who cares why you don't feel good. You know you'll feel better in a few days. Just deal with it. No matter what you have, you don't want to cough in anyone's face until you feel better. Who needs a test? Things have come a long way since the dark days of the COVID lockdown in 2020. 

Except at the Dana Farber Cancer Institute, that is. They still take this very, very, very seriously. As it turns out, I have an appointment supposedly scheduled for this coming Wednesday, January 3.  Ever since I was blacklisted, I've been wondering how I could get back in their good graces.

To clear my sullied name, the trial coordinator, Alice, emailed me with their requirements. I had to take two COVID tests this weekend 24 hours apart, and if they were both negative, I would be allowed to grace their halls with my presence on Wednesday. 

So I took a Covid test yesterday, which fortunately was negative. I took another one today which was still negative. Hooray! I emailed Alice back pictures of the two negative test results with time and date stamps. Hopefully, this will be enough for me to pass muster. Fingers crossed! Now I just hope that this three-week delay hasn't impeded my progress on the clinical trial. 

I said I would share any results I found about Dr. Richardson's paper at the ASH Conference. I found two recent YouTube videos where he discusses the clinical trial I'm on. Here are the links:

https://www.youtube.com/watch?v=SnRFxuh-aHk 

https://www.youtube.com/watch?v=34hCmqrE2JY 

In both of these clips, he talks about two separate arms of the study, the Daratumumab arm and the Elotuzumab arm. I'm not involved with the Elotuzumab part, so you can ignore the last part of these videos. 

If you get through the technical jargon, there are two major takeaways from these results. First, the overall response rate to the MeziDaradex trial is over 80%, up to 89% in some cohorts. This is remarkable! The other takeaway is that these responses are durable and long-lasting, with some patients still in remission over three years later. No wonder the staff at Dana Farber are so excited about this trial. Now I just hope that I will see the same benefits that most of the other patients have seen.

Bone Marrow Biopsy (Part 2)

This past Monday, I was scheduled for the dreaded bone marrow biopsy.  Since I had decided to take drugs, Holly drove me in in the morning for my first appointment. When it came time for the biopsy, I was given "conscious sedation", which consisted of an IV of Fentanyl (for pain) and Versed (for relaxation and memory block). 

Wow, what a difference! The procedure was a piece of cake. I'm going to go this route from now on with these biopsies. Holly picked me up afterward and we went back to their condo in Boston. I had no aftereffects.

On my last bone marrow biopsy on Oct 13, the results showed "monotypic kappa plasma cells present". Flow cytometry showed 1.8% of aberrant plasma cells in the bone marrow aspirate.  I was clearly diagnosed with a plasma cell neoplasm.

On Thursday, I got the results from the latest biopsy. This time, the result was clear: "No monotypic plasma cells detected"! They just disappeared! I'm flabbergasted. I can't believe how well this clinical trial is working right now. 

There's only one fly in the ointment. Sunday, I went to a funeral for an old college friend. One of the mourners became sick on Monday, and he tested positive for Covid. Since then almost all of us there have come down with it. I tested positive on Thursday. Being a good doobie, I called Dana Farber to let them know. To my shock and surprise, they told me I couldn't come back there for 20 days! this means I can't go back again until January. 

I'm really upset about this. After all the wonderful results I've achieved to date, I have to allow 3 weeks for things to possibly reverse. I realize that in severe cases, Covid can remain infectious for up to 20 days. So they are just going to let their cancer patients twist slowly in the breeze for 3 weeks? It doesn't seem fair.

I'll have to keep my fingers crossed that things will just pick up where they left off in January.

Looking Good

On Monday, I began my second 28-day cycle of the Mezi/Dara/Dex clinical trial at Dana Farber. I had several tests done to monitor my progress after the first cycle. They only update these tests once every cycle, so this is my first real snapshot of how I'm responding. Some of the results just came in today, so I thought now would be a good time to update my blog.

Multiple Myeloma (MM) is a cancer of the white blood cells. In MM, cancerous monoclonal plasma cells build up in the bone marrow. These crowd out the healthy plasma cells and make proteins that don't work right. This increase in monoclonal proteins is called an M-spike and indicates the presence of MM.

There are two ways to measure the M-spike. One is by blood serum electrophoresis, and the other is by 24-hour urine electrophoresis. Electrophoresis is a lab technique that allows proteins to be separated by size, and thus identify the monoclonal proteins. I had both of these tests done this week.

To consider MM to have relapsed, the blood serum M-spike must usually exceed 0.5 grams/deciliter (g/dL). My last two serum tests on Oct. 3 and Oct. 30 showed levels of 0.3 and 0.27 g/dL, respectively. While those are below the relapse threshold, they still represent a significant M-spike. The current test result was summarized as follows: "Immunofixation shows a faint M-spike that is not apparent on the electropherogram and, therefore, cannot be quantitated." Wow! It almost went away!

I also got electrophoresis results from my 24-hour urine sample. The last one I had on Oct 3 showed an M-spike of 115 mg/24hr. Again, while that is below the usual relapse criteria of 200 mg/24hr, it was still significant. Monday's urine electrophoresis test result was summarized as follows: "No monoclonal protein detected"! That is amazing! 

In addition to that, my Kappa light chain number, which had mushroomed and actually triggered my clinical relapse, is still back down in the normal range, where it had plummeted to after the first week. All other indicators are also good.

There is one other test I need to do that will measure the number of plasma cells in my bone marrow. I have a bone marrow biopsy scheduled for next Monday, Dec. 11. My last bone marrow biopsy on Oct. 3 showed a 5% level of plasma cells, below the relapse threshold of 10%, but still quite noticeable. 

I hate bone marrow biopsies! After my last one, I decided to opt for drugs this time. I'm going to have "conscious sedation" via IV to minimize the pain. Since I won't be able to drive, I'll be staying with Holly and Ryan in Boston on Sunday, and she has offered to take me in and back for this procedure, bless her heart!

Dr. Richardson is presenting his paper on this clinical trial this weekend at the American Society of Hematologists. I'm trying to find a way to get a video or a transcript of his presentation. If I can get it, I'll be glad to share it with anyone interested.

While this is still in the very early stages, I am thrilled that I seem to have responded so well over the first month. Dr. Richardson saved my life once. Maybe he can do it again.

Back in the Saddle Again!

I didn't update my blog last week when I got sent home for low white blood cell counts. I didn't want to scare anybody. 

I went back to DFCI yesterday hoping to resume my clinical trial treatment. Fortunately, my low white blood cell and neutrophil counts had completely recovered to their normal values. The Neupogen shot I got last Monday probably helped. I'm also feeling better from my cold, which probably also helped. So I'm back on the trial with only a one-week delay. Yes! 

While in the waiting room after my blood draw, I picked up the local weekly DFCI news magazine, "Inside the Institute". One of the articles was about a recent study that Dr. Richardson published in the New England Journal of Medicine about the effectiveness of my trial drug, Mezigdomide. The article published clinical trial results of combining Mezi with dexamethasone alone, which showed a 40-50% response rate, which is quite good. Of course, that trial preceded the one that I am now on including Daratumumab, which should provide even better results. 

I met with Alice, the trial coordinator. She told me that they are all excited about the paper on this trial that Dr. Richardson will be presenting at the American Society of Hematologists (ASH) convention in December. The results are starting to leak out, showing about an 80% response rate, and patients and oncologists from all over the world are now clamoring to get in on this trial. Unfortunately for them, the trial is closed to new patients as of now. Maybe they might open it up again...I don't know. 

Alice said that Dr. Richardson has been asked to present his paper at one of the major sessions of the conference. This is all very encouraging. I hope to be able to get a video, audio, or a transcript of his presentation. 

I hope everyone has a Happy Thanksgiving! I'll update this blog when I get more news.

Early Bird

In my last post, I said I'd let you know what the high-dose 40mg of dexamethasone would do to me. I then went to bed and slept like a baby. Oh well, who's to figure?

I worked out a schedule for taking the Mezigdomide pills. I kept them chilled in my bathroom overnight. When I got up to pee at my usual time around 5:30 or so, I took the pills and went back to bed. When I got up later, I was able to have normal coffee and breakfast. It worked out well. This week is my week off, so I don't have to worry about it.

Today marked Cycle 1 Day 8 of my clinical trial at Dana Farber. I had spent the weekend at the farm with Jeff, Christine, and Khoren closing it up for the season. I hitched a ride to upstate New York with them and planned to spend last night in Boston with Holly and Ryan. However, they weren't feeling well, so I drove my car home instead from Lowell.

My first appointment was at 6:50 a.m., so I set my Alexa alarm for 5:30. I awoke with a start and saw the clock said 5:45!  I didn't hear Alexa go off. I leaped out of bed, hurriedly dressed, grabbed my phone and computer, and jumped in the car. I was relieved to see that my GPS said I would get there in an hour.

About 40 minutes into the drive, I noticed something a little weird. It normally gets light here around 7:00 a.m., but with the clocks set to Standard Time, it should now be around 6:00. My car clock said it was 6:30, but it was still pitch black outside! 

Then dawn broke over Marblehead! It was 5:30, and none of the clocks in my apartment or car had been set back. My computer and phone had been on chargers, and my watch was in sleep mode, so I hadn't checked the time on them. Of course, Alexa knew it was only 4:30. Why didn't I figure that out? Duh!

Despite my bumbling early start, today was a much shorter one at Dana Farber. I didn't need to wait around for hours monitoring for side effects, so I got a blood draw, premeds, then the dex dosage, waited the prescribed hour to get the Dara injection, and left. The whole process only took about 3 hours, which should be the norm going forward.

I was curious about what my test results might look like one week into my clinical trial. I was hoping at the very least that the upward trends of my Kappa light chains and M-spike might have slowed a bit or even leveled off.

I haven't gotten my monoclonal M-spike electrophoresis results yet, but I did get my light chain report this afternoon on the Patient Gateway. I was blown away. My Kappa light chains have dropped all the way back into the normal range! Here is the graph of past results:

Kappa light chain history

This is so exciting!!! The entire last year's history of my Kappa light chain inexorably rising has been undone just one week into the trial. This was the only indicator that my MM had relapsed. Does this mean I may be back in remission already?

I don't want to get too carried away here. This is just one parameter to track. There may be other indicators that are not responding as well (M-spike?). Who knows? But I sure am happy about this! Am I on the right clinical trial or what? Yahoo!

Let the Games Begin

Yesterday was my first day at Dana Farber for Cycle 1, Day 1 (C1D1) of my Mezigdomide/Daratumamab/dexamethasone (Mezzi/Dara/dex) clinical trial. I started this trial just in time since the trial is closing to any more applicants after today! Phew! I feel very fortunate. Thank goodness for Dr. Richardson. 

It took most of the day. By "most of the day" I mean I was there from 7:30 a.m. until 7:00 p.m. It was a long day for a couple of reasons. First, after my blood draw and meeting with the nursing team, I went to the Infusion Center at around 10:00 a.m. to get my study drug (Mezzi) along with the subcutaneous Dara injection and dex. The Mezzi and dex are both in pill form. However, Dr. Richardson hadn't yet put in the order for the Mezzi, so I had to wait until 12:15 for the prescription to be filled. In the meantime, I had to take a bunch of pre-meds, including Decadron (dex), Tylenol, Singular, and Benadryl. 

After I got the Dara shot in my stomach at 12:30, I was forced to wait for 6 hours of observation to see if I had any adverse reactions. It wasn't completely boring, because the nurse, Dannielle (who is great!), had to take triplicate EKGs (!) along with various blood draws every hour! I was also able to squeeze in a Zometa infusion while there. 

I had a window in the infusion room, so I got to watch the traffic outside, which was marginally more exciting than not having a window. I had a fold-down chair, so I tried to nap a couple of times between procedures. Fortunately, I had no reactions to the Dara, so I was prepared to go home at 6:30. 

The EKG machine they use is old and slow. The first reading seemed to indicate that I was having a heart attack! I felt fine, so I was pretty sure that that was not happening! All subsequent readings were fine, however, so they determined that it was just a glitch artifact of the EKG machine. So far so good. However, just as I was about to leave for home, I was told to wait for the EKG doctor to go over all the charts again to verify that I could go. Fortunately, he must have noticed that I hadn't had a heart attack, so he signed off on it, and I got on the road around 7:00 p.m. 

Now that I'm on this clinical trial, I must start taking a bunch of additional meds. I already take about 10 prescriptions and supplements every day. Along with the Mezzi pill, which I must take daily for one week on and one week off, I now also have to take acyclovir, aspirin, Bactrim, and Pepsid (I can't take PPIs like omeprazole anymore). 

I have to figure out a schedule on how to take these drugs. I'm supposed to take the Mezzi in the morning, and I can't have coffee or any hard foods 2 hours before or after! If I pop the rest of those pills in the morning without eating anything or having my coffee, I will probably upchuck the whole lot! Hmmm. 

One of the nurses said that one of her patients wakes up early (4:00 am) to take the Mezzi and then goes back to sleep for a few hours so she can have her normal coffee and breakfast when she awakes. That sounds good to me because I usually stagger into the bathroom around 5 or 6 a.m. to pee. That would be a great time to take the Mezzi. 

I am scheduled to go in early in the morning again for the next few weeks. I won't have to do the 6-hour wait again, but at first, the days will include some wait time. After that, I sweet-talked the scheduler, Carmen, (smooth talker that I am) into moving most of my appointments to late morning or early afternoon. 

In the meantime, Holly and Ryan, who live in Boston, have insisted that I stay over with them on my early-morning appointment days. I'm very grateful! They are the best! And I get to see my gorgeous and irrepressible 4-year-old granddaughter, Kaia!

Kaia and Holly

To my chagrin, I see that I am scheduled for another bone biopsy on December 4. After my last experience, I want some drugs to ease the pain the next time. Since I won't be able to drive afterward, Holly has offered to drive me there and back that day. She is such a sweetheart! 

I took 40 mg of dex today, which is a lot. I'm writing this at 1:30 a.m., and I'm not even sleepy yet. If past experience is any guide, I won't get much sleep tonight. I remember during my first bout with MM, I would get up at night after my high-dose dex and think about doing something crazy, like reshingling the roof, painting the house trim, trimming all the bushes and trees, and patching all the cracks in the driveway. Like right then, with a flashlight! 

Now that I'm in an apartment, I don't have any homeowner tasks to do. However, I might want to get up and vacuum the rugs, do the laundry, re-organize my closet, clean the refrigerator, wash the windows, sort through items to donate to charity, water all the plants, or do some other task that hasn't occurred to me yet. Who knows? I'll lie awake thinking about it and let you know in a future post.

Bone Marrow Biopsy

I am now officially enrolled in the Mezi-Dara-dex clinical trial! I made it! My first treatment is scheduled for Monday, October 30, followed every week on Mondays for the next two months. 

However, I needed to go in for one more test beforehand: a bone marrow biopsy. So Friday morning I went into Dana Farber for this procedure.

Let me tell you about this. I laid flat on my stomach while the procedure nurse, Melissa, probed for the right spot on my hip bone to insert the "instrument".  Here is what it looks like:

This device sports a needle that seems to be much longer than it should be! 

The first thing she did was to inject a local anesthetic, first into the muscle, and then deeper into the bone. So far so good. Not too bad yet.

Now I've had these bone marrow biopsies several times before, but it has been quite a few years since my last one. The last time I took some drugs ahead of time to ease the pain. I was able to do that since Gretchen was there to drive me home. 

Now that I am alone and hadn't arranged for someone to drive me back afterward, I decided to tough it out like a he-man and do it cold turkey. Maybe it's like women giving birth. They forget how painful it was the last time, so they do it again, or so I'm told.

The thing is, once this instrument of torture dives deep into the bone marrow, the anesthetic doesn't really help. Multiple samples have to be taken and the marrow has to be sucked out. It's quite painful and time-consuming. To make things worse, I had also volunteered for them to take extra samples for research purposes. Duh!

Melissa (the torturer) kept saying, "I'm almost done". I don't know how many times she said that...I lost count. As I lay there gasping for breath, I was mentally kicking myself for trying to macho this out, or maybe I was actually kicking myself... I don't remember. 

After it was over, I clambered unsteadily off the torture rack and staggered out of the chamber with my undershirt hanging out of my pants. I didn't care. Next time, just give me drugs, lots of them!

I've Relapsed!

I met with Dr. Richardson at Dana Farber yesterday to enroll in the Mezigdomide (Mezi) clinical trial. In anticipation of my MM relapsing, I signed all the consent documents. I also went through a battery of tests yesterday and today, including providing a 24-hour urine sample, a transthoracic echocardiogram, supplying at least 20 vials of blood (a new record!), an X-ray skeletal survey, and an EKG.

The one test result that I was particularly keen on seeing was the Free-light chain blood test. One criterion for MM relapse is that the involved free light chain (in my case, Kappa) increases by more than 100 mg/L from its normal value. 

In my last post, I showed a chart of those results for the past several years. Up until 2023, my Kappa light chain has hovered in the normal range at around 18 mg/L. Then on my last visit in September, it had spiked to 112.8, almost meeting the relapse criteria. As I anticipated, the result from yesterday was 120.7, so I am now in a clinical MM relapse. The good news is that I am now officially enrolled in the Mezi clinical trial before the October 31 cutoff date. I should start the trial in a couple of weeks.

Dr. Richardson was extremely upbeat about this clinical trial. He said that the response rate to this protocol is over 80%, which is very good! He will be presenting trial results at the next ASH conference in December. He also said that this is a good trial for my high-risk t(4;14) cytogenetics. I wish I had recorded his remarks about this because I didn't understand half of what he said. However, the fact that he is confident gives me confidence.

So it begins! I will occasionally update this blog when I have some results to share.

I'm Back!

It has been over 3 years since I last updated this blog. Fortunately, I have remained in remission from Multiple Myeloma (MM) for all this time. I am an extremely lucky guy to have stayed in remission for more than 11 years. It's more than I could have possibly hoped for. However, all good things must come to an end. 

Over the past 6 months, I have noticed a steady deterioration in my blood test results.  In August, I got my first sobering hint of what was to come when my electrophoresis results indicated the dreaded "M-spike detected", which meant that there was now monoclonal protein in my blood. I then realized that the party was over. 🥳

As is my wont, I started researching Relapsed/Refractory MM (RRMM) to see what the preferred treatment options are after the first relapse. I found that many oncologists are recommending a regimen using one of the newer drugs, Daratumumab (Dara). A lot of the clinical trials to date have shown very promising results with Dara. 

I had an appointment with Dr. Richardson yesterday. While I haven't actually relapsed yet, I was confident that he would want to start some treatment soon, as he likes to hit things hard up front with everything he's got.  

Based on my research, I felt that it would be likely that he would recommend a treatment option containing Dara. I wasn't disappointed, but to my surprise, he offered to enroll me in a clinical trial with a new drug, Mesigdomide (try saying that quickly 5 times), coupled with Dara and dexamethasone (dex). This is an early Phase 2 clinical trial, so there aren't any results available yet.

He also offered me an option to enlist in another clinical trial. That one involves Ixazomib (Ninlaro), along with pomalidomide (similar to Revlimid) and dex. This was a blast from the past because Ninlaro was the drug I took in my initial clinical trial back in 2011! It has subsequently been approved by the FDA and is now a standard frontline MM treatment option. 

I have to reflect on how fortunate I am to be a patient at Dana Farber and have the world-renowned Paul Richardson as my oncologist. Where else would I be able to walk into my doctor's office and be offered on the spot two state-of-the-art clinical trials to choose from? I'm glad I don't live in Alabama.

After careful consideration, I decided that I wanted to join the first option. I spoke with the nurse today and I'll be making an appointment soon for pre-screening and signing consent forms. I asked her how the results have been to date. While detailed results are closely guarded until ready for publication, she said that her observations were that patients were responding very well to this protocol. That's encouraging!

There is one issue, however. The enrollment window for this trial closes at the end of October. If I am not clinically in relapse by then, I won't be eligible for this trial! So I'm in the uncomfortable position of hoping I relapse by then! Is that sick or what?

I just got yesterday's blood tests back today, and I don't think there is much doubt that I will be clinically relapsed very soon. One relapse criterion is that my involved (Kappa) free light chain (FLC) has to increase by 100 mg/L over its normal value. Here is a chart of this over the last 2 years:

As you can see, I'm perilously close to meeting that threshold. Again, I hate to keep saying this, but how fortunate will I be if I can slip under the wire and qualify for this clinical trial at the last possible minute. 

It reminds me of how I slipped into my first clinical trial in 2011. Someone had already signed up for the spot that Dana Farber had, but he had backed out the day before. They would have lost that spot to another cancer facility, but all they had reported was his initials, which happened to be WO. Since I had the same initials, I was able to take his place. the rest is history!

I remain optimistic and upbeat about this. Those of you who know me know that I respond to a situation like this as a problem to be solved and a challenge to be dealt with, not to wring my hands and say "Woe is me!". 

I won't wait another 3 years to update this blog. You should hear from me soon!