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Myeloma, Party Of Two: Summer, For Now

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Published: Jun 27, 2014 2:25 pm

The sun is shining, and our cats are dreaming in sunbeams about catch­ing quick-footed squirrels just out of reach. Summer … It feels good to finally be here, and so it’s fitting that I now conclude the three-part series on our journey from the dark days of my husband Daniel’s initial diag­no­sis to the brighter days of the present.

As I mentioned in my last column, we moved to Houston in 2012 so that Daniel could be treated by a myeloma specialist at the MD Anderson Cancer Center. I truly believe that the most critical decision you’ll make as a newly diagnosed patient is to seek the opinion of a myeloma specialist who is connected with a research hospital.

One benefit of being treated at large research centers is that they typically conduct many clinical trials in a given year. Early on, we expressed a desire to be notified if there was a trial for smoldering myeloma pa­tients such as Daniel that could offer us a chance at postponing his disease progression or even cure his disease.

In May of last year, we were given the opportunity.

We met with Daniel’s myeloma specialist for one of Daniel’s regular appointments, and we intended to talk with her about a clinical trial that we had read about online. It was for smoldering myeloma patients, and it involved a cancer vaccine that was intended to work with the body’s immune system to prevent further pro­gression of the myeloma.

Much to our welcome surprise, Daniel’s doctor brought it up first. It was a Phase 1/2a dose escalation study of PVX-410, a multi-peptide cancer vaccine, in patients with smoldering myeloma. (Testing of the drug may be expanded in the future to include patients with symptomatic myeloma.)

The goal of the clinical research study, which is still ongoing, is to test the safety of PVX-410. This includes trying to find the side effects of PVX-410 as well as trying to find out how much of the vaccine can be given safely to patients. The study also tests the body’s immune response to see whether the PVX-410 works against smoldering myeloma.

We learned that PVX-410 contained proteins that are usually found in myeloma cells. They hope that these proteins will trigger a response from the immune system. During the trial, they also administer hiltonol (also called Poly-ICLC), which stimulates the immune system -- hopefully helping the vaccine to work more effectively.

We had some tough decisions to make, and not a lot of time to make them, as the trial was recruiting then and the spaces were filling up fast.

Once we learned more about the trial, we did have some concerns. Neither one of us took the decision to participate lightly.

Obviously, we hoped that the trial would be successful. It could potentially lead to a cure for all myeloma patients, not just Daniel. It was important research, and the study needed participants. This left us with a sense of responsibility to the whole myeloma community.

On the other hand, this was a dose escalation study designed to text toxicity levels in humans. There was always a chance that things could go badly. We were also concerned about whether Daniel’s participation in this trial might exclude him from future trials if this one failed.

At the end of the day, Daniel and I agreed that it was far better to participate in the trial while he had smol­der­ing myeloma. By the time the vaccine might be approved by the Food and Drug Administration (and be avail­able on the market), Daniel might already be symptomatic, in which case the drug (currently intended for smol­der­ing patients) might not be helpful to him. Plus, we couldn’t help but think of the patients and their families who would be helped by the study if it were successful.

It was a tough decision, to be sure, but it was made easier by the tougher conse­quences of in­action and the possibilities of an outcome that could help all myeloma patients. We chose to participate in the trial.

To be admitted to the study, Daniel had to clear a few hurdles.

First, he had to have a specific protein in his blood, and there was about a 50 percent chance that he had it. Several interested patients had already been turned away because they didn’t have it. Second, Daniel also had to undergo another bone marrow biopsy and additional scans to prove that he was still smoldering and hadn’t developed lesions or other signs that his disease had progressed to active multiple myeloma.

Thankfully, a blood test indicated that Daniel has the necessary blood protein. Next, he had the other pro­cedures done again. It had only been six months since his last bone marow biopsy, but we held our breath that the results wouldn’t reveal signs of active myeloma or additional chromosomal abnormalities.

While Daniel’s biopsy showed a 3 percent increase in the myeloma cells in his bone marrow, we were re­lieved that he was still lesion free, and verified as still having smoldering myeloma.

He was admitted to the study in May of 2013.

Daniel was placed in the second patient group, which meant that he was receiving the second highest dose of the vaccine (there typically are no placebos given in Phase 1 clinical trials).

For the next six months, he went to the hospital every two weeks for injections of the vaccine, 24-hour urine testing, and copious blood draws to see how the vaccine was working.

Upon treatment completion, he was observed for 12 months with the same blood and urine protocols, but no medication. Daniel has been in post-trial observation since the beginning of this year.

While taking the vaccine, he experienced considerable fatigue, some headaches, and flu-like symptoms during the first one to three days of each administration.

On one occasion, he had an intense skin reaction with fever that may have been due to misadministration of the drug. Otherwise, things seemed to go without any major incident.

From what we could gather (they’re all very secretive about these things), Daniel’s side effects were con­sis­tent with those of other trial participants. We were very thankful that he didn’t seem to experience any major side effects.

We don’t know what the conclusive results of his phase of the study were, since the trial is still ongoing. Over the past year, Daniel’s M-spike has been hovering around the same level (give or take marginal adjustments) that he had at the beginning of the trial. We hope that is the result of the vaccine, but we can’t know for certain.

Honestly, it’s a bit surreal to see vaccine trials mentioned in the news, and know that my husband par­tic­i­pated in one of them. With every clinical trial, researchers learn about what worked and what didn’t, and we all take one step closer to a cure.

I admire my husband and all patients who bravely navigate the unknown. For them and for all their families, I pray that we find a cure soon.

I’ve learned that dealing with myeloma is a journey. There are hills and valleys along this road, and it’s hard to share such a story without the details, thoughts, and feelings that shaped the decisions we made and the road we took to the present.

Eleanor Roosevelt once said, “People grow through experience if they meet life honestly and courageously.  This is how character is built.” Now, I am attempting to live up to Mrs. Roosevelt’s advice, and to do so with as much love, selflessness, and strength as I can muster.

We’re thankful to be aware of Daniel’s condition, especially since so many are diagnosed after their disease has progressed.

We plan to spend the next several years (we hope) traveling and treasuring our time together, relatively free from the treatment regimen that can interrupt future plans. We are blessed with a deeply committed, loving marriage, which I believe, makes us the luckiest of couples.

For now, we finally feel the warmth of summer. I doubt that I’ve come through the winter as courageously as Mrs. Roosevelt might have done, but we came through it together -- and that is far more important.

I don’t know where our path will lead, but my travel companion makes the destination worthwhile. So, with a deep and abiding love, we venture forth, enjoying every moment of this beautiful life.

When the rains and snows return, we will stand against them again, but for now, it feels good to be in the light.

Tabitha Tow Burns writes a monthly column for The Myeloma Beacon. In 2012, after an initial diag­no­sis of MGUS, her husband Daniel was eventually diagnosed with smoldering myeloma. You can view a list of her previously published columns here.

If you are interested in writing a regular column for The Myeloma Beacon, please contact the Beacon team at .

Photo of Tabitha Tow Burns, monthly columnist at The Myeloma Beacon.
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6 Comments »

  • Nancy Shamanna said:

    Thanks Tabitha for the interesting column about Daniel going through a clinical trial using a multi-peptide cancer vaccine. i am sure that you must have been apprehensive about sailing into uncharted waters, and I am glad to know that he did well on the trial, and that his SMM did not progress further. It would be nice to see a treatment that diminished the M protein though, and I wonder if any of the trial participants will have that result.

    It's interesting about clinical trials ... I have heard more than once when attending talks given by researchers, that it can be quite difficult to recruit enough eligible participants for a clinical trial. And yet, you mentioned that the trial filled up very quickly, and I have heard of the same thing happening here. Apparently in very large worldwide trials, only a certain amount of spots are assigned to each location. Usually a clinical trial is the only way a patient may get access to a new drug that is not approved yet.

    Many of the drugs used to treat myeloma are quite recently approved, and I think there is a type of observation, or trial, called phase 4, to observe the performance of recently approved drugs. I know that the drugs I was on a few years ago, velcade and revlimid, were only recently approved, and I did feel a bit like a guinea pig, as did other patients I talked with at the time! But they worked well, and am very grateful for that!

  • Sandra said:

    Thank you, Tabitha for yet another well written article. Your writing never fails to engage the reader and provide insightful and valuable information. We look forward to your next one.

  • Tabitha Burns (author) said:

    Nancy, thank you for pointing out an interesting detail about the trial. This trial was a national effort in cooperation with several research hospitals. As I recall, the trial was being conducted in Boston and Atlanta, as well as in Houston. Indeed, the spaces filled up quickly since they were spread out between several hospitals. Plus, as far as toxicity trials go, there were very few down-sides to this trial, since it was a vaccine and not a traditional myeloma drug, which also led to its appeal.

    In terms of feeling a guinea pig, I bet that you're experience Nancy was a whole lot more of a nail-biter than ours! Like the wonderful research that came out of your trial, I hope that this one leads to a good result for lots of patients.

    Sandra, thank you for your kind comments. I'm glad to have had the opportunity to share our diagnosis story and the road we took to the clinical trial. I hope that my future columns will be as amusing and insightful as the many great columns from Beacon contributors!

  • dinesh kadam said:

    When vaccine came in market?

  • Tabitha (author) said:

    Hi Dinesh,

    Thanks for your question. To my knowledge, the vaccine is not yet on the market. The clinical trial is still ongoing, but we hope that it yields great results!

    Thanks,
    Tabitha

  • dinesh kadam said:

    Thanks for your reply, a waiting for your good news regarding myeloma desease