Two weeks ago I ran part one of Danny Parker’s column, Thoughts from the Edge of Relapse.  I was waiting for Danny pass along his latest test results.  Did RVD (Revlimid/Velcade/dexamethasone) do the trick?  Was it able to vanquish his wakening multiple myeloma before it picks up a head of steam?

Here’s Part Two:

My reaction to two months of RVD therapy to head off relapse at the pass? A desire for a break! In particular, the Dexamethasone plays havoc with my sleep (can’t sleep for two days, then can’t stay awake for the next two), my digestion (acid reflux—thanks for forGelusil) and leaves me worthless at work for half of the work-week. Our plan is to see if the 2nd round of RVD helped again to push the numbers back down. We will plan on doing sub-q Velcade every other week as maintenance with 10 mg/day Revlimid and see how that might help over the coming months.

If and when that fails, I will at least be starting from a low disease burden as I search for other therapy options. There are, of course, several others such as Pomalyst, Carfilzomib and others just coming on line. In particular, Daratumumabwhich seems likely to soon see approval seems particularly active in relapsed myeloma, although Dr. Wolf is even more excited by SAR-650984- the Sanofi anti-CD38 monoclonal antibody.

http://www.myelomabeacon.com/resources/mtgs/ash2013/abs/284/

The question there is, however, whether one can get into a clinical trial—particularly if you have not relapsed in a big way? Generally, the qualification criteria for most trials is a hunky m-spike or the iFLC greater than 100, or observed lesions and clinical symptoms or a bone marrow biopsy of 60% plasma cells. All of the preceding, as you may have guessed, would indicate active steam-rolling-butt-kicking myeloma.
Trouble is, you see, qualifying for clinical trials means you have active disease—something that the MRD “theory of everything” for myeloma depicts as particularly unappealing. See the problem?

We need better drugs to treat myeloma and we need clinical trials and patients participating in them to establish their efficacy. The drugs available in clinical trials such as Ixazomib, DTP3, LC161 and the touted engineered measles virotherapymay be great, but to qualify to get them you have to have something way beyond MRD. You need to have active myeloma. So, they better work, and you have to hope you are not in the randomized placebo arm of a Phase II or Phase III clinical trial! And then the other problem: many of these cutting edge therapies have a very limited number of subjects, particularly for the Phase I trials where you are often assured of getting the drug. It is hard to get in. Gads.
So, I’d like to pose two pet hypotheses at this point about relapse:

• If MRD has clinical significance for OS, then treating early before full relapse may prove better

• It would be useful to have clinical trials that embraced patients on the cusp or relapse with relaxed criteria and compared those to ones where patients were more fully relapsed.

Note that I said “may prove better.” This is highly speculative. Without clinical trials that can’t be known, but there’s a show-stopping chicken and egg problem: clinical trials only come when relapse is fully established. You can’t have results for something you don’t test. So, what to do?

I leave that to the experts, but as a more-than-interested observer, I humbly suggest these questions are useful to ask.  But many of you might recall my obsession with diet over recent years and its possible influence on myeloma. I believe diet has helped me over the last four years and pretty much stand by the recommendations I previous made in Pat’s blog.

http://multiplemyelomablog.com/2012/11/diet-and-multiple-myeloma-danny-parkers-dietary-recommendations.html

However, recently I have learned some additional things that are potentially compelling.  Indeed, I intend to see if I can bolster my Revlimid-Velcade maintenance in the New Year. More from me on that in a future column.

Hint: it might be important to find a way to control your blood glucose and keep it low and stable.  How will that be possible with mashed potatoes and pumpkin pie?

Until then, I wish all in the myeloma community a warm and nurturing final days of autumn.

How did Danny’s tests work out?

Pat,

Things were stable and slightly improving (Free Light Chain Ratio) in the November test.  Here is the plot showing what happened with most recent free light chain results. Still not normal, but adding Velcade to the maintenance mix appears to have made a difference.

dp

Dannys graph

To me, stable is good!  Glad that you’re doing so well, Danny!  Talk about detail organized!  I don’t even enter my results onto a spread sheet; just get a hard copy, take a quick look and file it away.

Feel good and keep smiling!  Pat