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Smoldering Myeloma Clinical Trial Updates

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Published on November 13, 2019

Key Takeaways

  • Early therapy is considered a current standard treatment for high-risk patients.
  • Talk to your doctor about early therapy options vs. possible long-term resistance.
  • Current ECOG trial is lenalidomide-dexamethasone vs. daratumumab-lenalidomide-dexamethasone.  

What does current clinical trial data show for high-risk smoldering myeloma? How can patients reduce their risk of developing multiple myeloma? At a recent Town Meeting in Houston, Texas, Patient Power host and advocate Jack Aiello sat down with myeloma experts Dr. Sagar Lonial from Winship Cancer Institute and Dr. Krina Patel from MD Anderson Cancer Center to discuss patient outcomes for high-risk smoldering myeloma. Watch as the experts share the latest findings and trials as a treatment option.  

This town hall meeting is sponsored by Janssen Biotech, Inc. and Karyopharm Therapeutics with additional support to our partner, Myeloma Crowd (MCR), from Takeda Oncology and Foundation Medicine. These organizations have no editorial control, and Patient Power is solely responsible for the content. It is produced by Patient Power in partnership with The University of Texas MD Anderson Cancer Center.

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Transcript |

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That's how you’ll get care that's most appropriate for you.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Jack Aiello:                

Dr. Lonial, can you summarize what trials are telling us now about high-risk smoldering myeloma?

Dr. Lonial:                 

Well, you know, the trial landscape is pretty broad. There are lots of trials that have gone from low-intensity therapy to something involving triplet or quadruplet induction, two transplants and three years of maintenance for patients that fall into high-risk smoldering.

I think it’s important to recognize that there really are only two randomized trials that have been completed in this setting. Both of them compared early therapy with observation. Now, the Spanish trial is much older and has much longer follow-up than the US trial, but that trial also had some issues with it. I think the flow cytometry piece that you mentioned is a concern. They used regular X-rays as an entry criteria for that trial.

So, one of the concerns I that perhaps there were patients that we would now call myeloma based on MRI or PET scan that may have been included in that trial. But nonetheless, it showed a longer remission duration or longer time to developing myeloma and they showed a survival benefit for the use of early therapy. But those weaknesses limited widespread adoption.

 So, at ASCO this year, I actually reported data on the largest randomized trial ever done in smoldering with lenalidomide (Revlimid) alone versus observation. We demonstrated the same magnitude of benefit that the Spanish showed. In fact, if you take that 20/2/20 group that you described as the high risk, there was a 90 percent risk reduction of developing myeloma within three years by using just lenalidomide alone.

So, at least in our view and at least the conclusion in the manuscript that was accepted two days ago says that we recommend that for patients that are high risk if they’re not gonna go on a trial or they can’t get on a trial that early therapy with either len or len-dex (Revlimid-Decadron) is a standard of treatment approach.

Now, I think there are a lot of investigations. There are doublets and triplets and all sorts of complicated trials, but until we demonstrate that those trials are better than our current standards, I think it’s hard to say we should go with more intensive therapy than just lenalidomide alone or lenalidomide-dexamethasone.

Jack Aiello:                

So, based on that paper, at least you and Emory and folks are recommending that high-risk smoldering patients be treated or at least be offered that option. 

Dr. Lonial:                 

Yeah. We would want people to enroll on the current ECOG trial. The ECOG trial is lenalidomide-dexamethasone versus daratumamab-lenalidomide-dexamethasone (Darzalex-Revlimid-Decadron), which addresses that question of more intensive therapy.

But I think the ideas that treatment in the context of smoldering has to show a survival benefit misses the fact that if you prevent organ damage, that’s a big deal. If you prevent a fracture, if you prevent the development of bone disease, if you prevent renal failure, that’s a huge deal.

With myeloma patients living 8, 10, 12, 25 years, the idea that you’re gonna see a survival benefit in our lifetime for a randomized trial is pretty low. So, I think we need to be comfortable with the idea of reducing risk and improving quality of life

.

 

Jack Aiello:                

Quality of life is so important. And you would agree, Dr. Patel?

Dr. Patel:                    

So, I definitely discuss it with all of my patients. I’m gonna give a little bit of controversy to this, but I agree. I think this is the best trial we can now use as backbone to compare all our other trials. If there are trials, we try to get patients—and Dr. Manasanch actually does most of our smoldering trials.

However, on the flip side, if you say 50 percent of patients are likely to get myeloma in two years, what about the other 50 percent? So, do I have patients that fit that high-risk criteria that are nine years going without any treatment and still doing well. So, that number to treat, that number needed to treat to help patients, I think our goal is to get better at figuring out what high-risk really is and I do think we need better ways to say someone is high-risk.

Once we have that, then yes, then I think all those patients should be treated. When we don’t have—it’s still a 50-50, I talk to my patients and I tell them based on this data, recommendations would be to start treatment. However, let’s talk.

Then we decide if it’s the right thing to do or not. The other question is are we gonna have more resistance? What do we do when someone relapses again? Then what treatment do we do? All the trials we’re doing now will give us those answers in the future. So, yes, we definitely discuss it.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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