Published on May 2, 2019
If a multiple myeloma patient has success with CAR T-cell therapy, is a maintenance treatment necessary? Noted myeloma expert Dr. Elisabet Manasanch, from The University of Texas MD Anderson Cancer Center, discusses research on evaluating treatment response and follow-up care. Dr. Manasanch also explains the significance of the M protein level for myeloma patients and what the next generation of clinical studies on CAR T-cell therapy will investigate.
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Transcript | Is There Maintenance Treatment After CAR T-Cell Therapy?
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Here’s a question we got in from Darrell. And, doctor, I think you answered this, but I just want to make sure. So, he said he did have a very successful CAR T, and all markers of disease in the bone marrow were zero. PET scan analysis, no evidence of rival disease.
But the M spike, after 90 days, has remained 0.1. Is it possible, and I think he said this, that the M protein just takes a little while?
It’s possible. It’s possible that maybe there are some cells that are making that M protein somewhere. But, again, as long as the cells don’t get worse, who cares? If you have an M protein of 0.1, and that’s not making you sick, and it’s going to stay 0.1 for 10 years, that’s not going to kill you. An M protein of 0.1, that doesn’t get worse. So, the key here is, if you stay there, that’s okay. The problem is, if it goes from 0.1 to 0.2 to 0.4 to 1.0, That’s when we get into trouble. If, for some reason, there is the balance of your body or immune system is just letting some cells be there and make a little bit of protein, and that’s it, that’s great.
That’s all you need, to not get into trouble, with the myeloma.
So, that’s possible, of course. You can have everything negative and a little protein, and the light chain is a little bit high. That happens. But it could just be that it’s just lingering a little bit longer. It could be that there are some cells making it that are not doing much. It just has to be followed.
Okay. Just to be clear, Darrell asked a follow-up question. After CAR T, then, why not start a maintenance treatment, even if you’re MRD-negative? So, is that what is the protocol for the CAR T? Or what are you doing at MD Anderson?
Well, that’s a very good question. I think that’s probably like the next generation of studies, with CAR T. So, right now, when we design clinical trials, you have to, basically, make an end point, right? So, what’s your goal, when you do a study? What do you want to prove? What are you trying to say about this?
And they do studies with CAR-T cells really mostly have two end points. One is safety. So, make sure that you’re going to give the cells. People are not going to die from toxicity. They’re going to actually going to be able to go through with this. And then, the second one is how effective is this, so what are the responses? How long does it take after a response for the myeloma to come back? So, those are the main things. So, if you do a CAR T, and then, you put a therapy right after, it’s very difficult to isolate the effect of the cell therapy. So, you, ideally, want to do a study with cell therapy that is just a cell therapy.
Now, once we have established that this cell therapy is safe, and the CAR-Ts are safe, and they are effective, then, the next generation of studies is you can add things to it. Usually, we have to build on things. So, you have to have a basis. So, right now, there are already studies looking at comparing CAR-T cell to standard therapy.
So, for like patients that are not just relapsed after 10 lines of therapy, patients that have relapsed a little bit sooner, maybe like second lines, first or second relapse. You can get CAR T, or you can get another therapy. And then, basically, this is something that has to be studied. There is no data, right now, that I’m aware to do any therapy after CAR-T cell. So, that’s why people don’t do therapies because we have not gotten to it yet. So, that’s a good question. Somebody is probably doing a study right now doing therapy after CAR-T cell. But I have not seen any results from any studies like that.