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What Does the StaMINA Trial Mean for Myeloma Patients?

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Published on June 15, 2020

What is the StaMINA trial, and what does it mean for multiple myeloma patients?

In this segment from our recent Answers Now program, patient advocate Cindy Chimielewski explains what the StaMINA trial is and shares the latest results from this six-year study. This trial was recently presented at the 2020 American Society of Clinical Oncology (ASCO) annual meeting. Cindy and host Jack Aiello talk about what type of patients would benefit from this tandem transplant study along with other information for those with high-risk myeloma. Watch now to learn more.

This is the third part of a five-part series. Watch Part 1 at What Does the ENDURANCE Trial Mean for Myeloma Patients?, Part 2 at CAR T-Cell Clinical Trial Updates for Myeloma Patients, Part 4 at Treating Myeloma in Patients with Renal Insufficiency, and Part 5 at New Treatment Options Give Hope to Myeloma Patients .

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Transcript | What Does the StaMINA Trial Mean for Myeloma Patients?

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.

Recorded on June 5, 2020

Jack Aiello:

I want to welcome my fellow patient advocates. We have Cindy Chmielewski from New Jersey joining us, I have Maddie Hunter from outside of New York City joining us, and Jim Omel from the great state of Nebraska with us. And together, we're going to talk about key takeaways that each of us saw at ASCO.   

So just to give you some background, what the heck is ASCO? Each June researchers from around the world gather to share their findings in Chicago, except this year with the COVID-19 this sharing of discoveries was done virtually. But nearly 43,000 attended from 138 countries to provide both oral and poster presentations with prerecorded videos and slides.        

While ASCO predominantly focuses on solid or tissue cancers, there were several excellent updates provided for the myeloma community. Why do you care about this? Well, with new research, it could change your treatment plan. The research could provide you with questions to ask your doctor. And ultimately like me, I think it gives you hope.

Good. In fact, Cindy, let me ask you to introduce yourself. And I know you're going to talk about a trial. All these trials have interesting names, but this one in particular is called StaMINA.

Cindy Chmielewski:

Right, yes. My name is Cindy Chmielewski, and I have been living with myeloma since 2008, almost 12 years. And I'm talking about the StaMINA trial. And I was just going to say what Jack said, all these trials do have interesting names. They also have numbers that go along with them. So sometimes they refer to them by the numbers. Sometimes they refer to them by the name. And StaMINA refers to "stem cell transplantation for multiple myeloma incorporating novel agents." So they even get tricky with their acronyms when they give us these names for trials.      

But I'm kind of glad to be presenting the StaMINA trial, because it's kind of a trial that's been going along for a long time. This is the six-year readout. But back when I was diagnosed in 2008, we did not have the treatment options that are available today. There really wasn't that much of a selection. So a big question that I had, and people around the time that I was diagnosed had was, should I have one transplant, or should I have two transplants called a tandem transplant? Like Jack said he had. And that was a really big question, you didn't really know what was happening. So this trial, answered that question and a little bit more, so the initial part of the trial is everyone started with induction therapy. Everyone on this trial had the first transplant. After the first transplant people on the trial were randomized to three arms.

One of the arms was people went on and had a second transplant, or a tandem transplant, after the first transplant. The second arm of the trial, people in that arm did four cycles of consolidation, and consolidation means they had a stronger treatment. And in this consolidation treatment, it was RVD for four cycles. And then they went on to Rev maintenance, or Revlimid maintenance. And the third arm of the trial just went straight to Revlimid maintenance. And about, I guess, probably around after 38 months of the trial, Dr. Stadtmauer from UPenn, presented the initial results that showed that there was no difference in overall survival or progression-free survival in all three arms of the trial.

Jack Aiello:

And he presented those results three years ago, right?

Cindy Chmielewski:

Three years ago, yes. After 38 months of people from being randomized. Now this is three years later, and these results would happen with a group of people who, after the initial results were presented, these people were still in a remission. These people have continued with Revlimid maintenance up until that point, so they were eligible to enter the second part of the trial. And if they did, they were part of one of two arms. One arm was continued with Revlimid maintenance, the other arm of that trial, they stopped Revlimid maintenance. And the stopping wasn't a randomization, it was because the patient decided to stop or their doctor thought it was best for them to stop. So we had that kind of data.

And results, so these results are a little tricky when they first presented them, because they gave us the results in two ways. They talked about the results with the intent to treatment, but they also talked about the results as to what treatments the patients actually had. And I thought those results were better meaningful for us, because we want to know what happened once patients were treated.

And what they found when they reviewed the results as to the treatment that the patients received, that once again, all three arms, the progression free survival and the overall survival were the same, except when they teased out the group of high-risk multiple myeloma. And when they teased out the group of high-risk multiple myeloma, there seemed to be a benefit to that group of people to go ahead and have a tandem transplant. And that was with the intention to treat. That was with the actual treatments that they actually received. And they also found out that the people that were in the arm that had continuous Revlimid to progression had a longer time to progression than the group of people that were in the arm that stopped Revlimid maintenance.

So I guess there were three key takeaways for me. First, if you are a standard risk, multiple myeloma, one transplant is enough. You don't need to go through two. If you have high-risk multiple myeloma, then you might want to have that conversation with your doctor, is there a benefit for me going through tandem transplants, having one transplant and another one planned back to back? And the third key takeaway for me was that staying on continuous Revlimid maintenance until progression seems to benefit at least for progression-free survival. And that's my key takeaways from the StaMINA trial, which it was pretty nice to see that results were six years out. And the groups of people there were in the second cohort, there was over 400 participants, so it was a large sample size. So I felt they were pretty impressive results.

Jack Aiello:

So this is the second time we've talked about high-risk patients. The ENDURANCE trial that Jim discussed didn't really include high-risk patients. Cindy mentioned that maybe tandem transplants are favorable for high risk patients. There was actually another study that focused specifically on high-risk patients presented at ASCO. It actually looked at VRD as the standard induction treatment plus or minus elotuzumab (Empliciti). Elotuzumab is one of those monoclonal antibodies. And it was specifically for high-risk patients. And the belief going in that maybe with the addition of elotuzumab, we will see benefits in progression-free survival and overall responses.

And it turns out that the use of elotuzumab plus RVD, both in induction, using it as elo plus RVD, and in maintenance with elo, did not improve the patient outcomes. So that was a surprise, in some sense, it's a bit like Jim's comments in that it's a negative trial that it didn't really meet the hypothesis that we thought was going to happen. But it's important for patients to understand that necessarily adding a drug might not have a benefit. And there's still a big area of need for high-risk patients.   

Maddie Hunter, let me ask you to introduce yourself. And I know you're going to go over some trials that have to do with renal or kidney insufficiency. Can you talk about that?

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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