I am taking a hard look at switching from Revlimid for maintenance therapy to Kyprolis (carfilzomib) with dexamethasone to treat relapsing myeloma.
It appears based on past trials with Kyprolis that is has less neuropathy problems than Velcade but more heart problems. Looking at past trials, there has been up to a 19% rate of heart- related problems, which is not a small number. There is a trial study proposed for me, the SWOG S1304, that has two starting arms, one at a lower dose that I believe is the standard FDA approved dose in place today and the other arm is at a higher dose, which I believe is 27 mg/m2, but I need to check. The study monitors participant heart function with EKG and ECHO and blood test after cycles 3,6,9,12 and when finishing treatment, which is normally 12 months.
For those who have used Kyprolis not in a trial setting, has it been standard practice to monitor heart condition to detect the onset of problems, or has this only routinely done in a trial setting for Kyprolis? I will be asking more about this with my oncologist too.
I am also curious if the heart-related problems tended to resolve themselves after Kyprolis was stopped. Last thing I want to do is screw up my heart such that it complicates potential treatment option later in other trials or outside of a trial setting. Especially with the possibility of immunotherapy being not too far away.
Any information on just what the risk of heart damage is would be helpful.
Second question, at this time I am still in pretty good shape and can work, travel and still have plans to travel in the future inside the United States. For those who have been in trials, have you been able to have your drugs administered by another hospital or institution that is also participating in the trial while on travel?
For the trial I am looking at, I understand they pay for the cost of the drugs but not the preparation and administration of the drugs, so that would still have to be covered by my insurance. I would not expect that an institution outside of my regular one would be allowed to do the other medical care that is part of the trial, just the drug administration.
I plan to follow up with the trial organizers to ask this question, but I am curious if anyone has experience with this. Being able to get the drugs administered else would be a significant plus for choosing the trial option.
Forums
Re: Kyprolis clinical trial - heart & travel questions
Hello Eric. I am about to start my third cycle of Kyprolis on Thursday. I have atrial fibrillation and a prolapsed heart valve and my oncologist is fully aware of my cardiac issues. No type of cardiac monitoring is being done, but maybe it should be. I tolerate the drug extremely well with none of the side effects.
Of course, I said the same thing about Velcade until the seventh cycle, when I suddenly developed severe neuropathy. I'm on Kyprolis because my choices are limited. Velcade causes neuropathy, Revlimid was only minimally effective, and my ASCT failed, so my disease is resistant to melphalan.
Why do you want to switch your maintenance drug from Revlimid to Kyprolis? If I had a choice, I would choose Revlimid. Revlimid is an easy oral medication and Kyprolis is a twice weekly IV infusion that takes about 3 hours. If Revlimid is keeping the myeloma monster in its cage and you are tolerating it, I would suggest you stick with it and reserve the Kyprolis bullet for when you become refractory.
Best of luck.
Of course, I said the same thing about Velcade until the seventh cycle, when I suddenly developed severe neuropathy. I'm on Kyprolis because my choices are limited. Velcade causes neuropathy, Revlimid was only minimally effective, and my ASCT failed, so my disease is resistant to melphalan.
Why do you want to switch your maintenance drug from Revlimid to Kyprolis? If I had a choice, I would choose Revlimid. Revlimid is an easy oral medication and Kyprolis is a twice weekly IV infusion that takes about 3 hours. If Revlimid is keeping the myeloma monster in its cage and you are tolerating it, I would suggest you stick with it and reserve the Kyprolis bullet for when you become refractory.
Best of luck.
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Dano - Who do you know with myeloma?: Me
- When were you/they diagnosed?: Jan 2014
- Age at diagnosis: 65
Re: Kyprolis clinical trial - heart & travel questions
My husband has been on Pomalyst and Kyprolis since October. He had no cardiac work-up prior to, or during this, until January, when he was having a hard time with shortness of breath, At that time, they did an echo and chest x ray, which were normal. They cut his dosing from 3 weeks on, one week off to every other week. The sob (not referring to dear husband!) has improved.
Since being on these meds, he has continued to work out at the Y 4 or 5 times a week, and work part time. We went to Jamaica for 2 weeks (skipped a week of chemo) in January, and left snowy Michigan for the month of March to stay in Arizona. He had his auto transplant at Mayo in Minnesota, 3 years ago. While we have been staying in Scottsdale, he has been receiving chemo at Mayo Scottsdale. When he brought up our travel plans to the infusion nurse back in Michigan, she said they arrange "travel chemo" for patients all the time.
Since being on these meds, he has continued to work out at the Y 4 or 5 times a week, and work part time. We went to Jamaica for 2 weeks (skipped a week of chemo) in January, and left snowy Michigan for the month of March to stay in Arizona. He had his auto transplant at Mayo in Minnesota, 3 years ago. While we have been staying in Scottsdale, he has been receiving chemo at Mayo Scottsdale. When he brought up our travel plans to the infusion nurse back in Michigan, she said they arrange "travel chemo" for patients all the time.
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rumnting - Who do you know with myeloma?: husband
- When were you/they diagnosed?: 4/9/11
- Age at diagnosis: 54
Re: Kyprolis clinical trial - heart & travel questions
Hi there. I've been on 2 clinical trials, and generally the requirements are pretty strict about traveling and being available for various lab workups required for the study. It's not like a particular treatment where you can take a break, skip a week, or go to another hospital or clinic.
I'm curious why you have to be on a trial for Kyprolis. I took in as part of a regular treatment regimen. It just didn't work for me. You have much more flexibility when you are not on a trial. That's been my experience anyway.
I'm curious why you have to be on a trial for Kyprolis. I took in as part of a regular treatment regimen. It just didn't work for me. You have much more flexibility when you are not on a trial. That's been my experience anyway.
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micallie
Re: Kyprolis clinical trial - heart & travel questions
Yes, Eric, it is standard practice to monitor cardiac markers during treatment with Kyprolis. Up until recently, my husband was having his cardiac markers followed via a BNP blood test. We recently had to put a stop to that blood test, though, since our insurance company.declined to pay for it because they considered it experimental. Right now an appeal is in to the insurance company, but until we hear from them, we have to decline that test. At 1200 bucks a test, we just could not afford to keep having it done. You may want to look at your insurance coverage in regards to that.
We have been told that, since we do a lot of camping during the summer, that they can make arrangements for him to have his treatment at hospitals near the campgrounds. However, I do see where, if you are in a trial, that may inhibit any travel plans you may have.
We have been told that, since we do a lot of camping during the summer, that they can make arrangements for him to have his treatment at hospitals near the campgrounds. However, I do see where, if you are in a trial, that may inhibit any travel plans you may have.
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Melanie - Name: Melanie
- Who do you know with myeloma?: husband
- When were you/they diagnosed?: July 2014
- Age at diagnosis: 54
Re: Kyprolis clinical trial - heart & travel questions
Hi Eric,
Glad to see that you're getting helpful feedback regarding your questions.
If you're considering treatment with Kyprolis in the context of a clinical trial, another option you may want to consider is the trial of Kyprolis plus filanesib (ARRY-520). All the participants in the trial will get Kyprolis; two thirds will also get Kyprolis in combination with filanesib. For the third who don't get filanesib, they will have the option of going on to the drug if Kyprolis alone is not enough to control their myeloma.
You can find a description of the trial here:
http://www.filanesibtrials.com/trials/array-520-216/array-520-216-trial-details/
The page also has a link to the description of the trial at clinicaltrials.gov.
(Full disclosure: Array BioPharma, which is developing filanesib and is sponsor of the trial I just mentioned, is also a sponsor of The Myeloma Beacon.)
Glad to see that you're getting helpful feedback regarding your questions.
If you're considering treatment with Kyprolis in the context of a clinical trial, another option you may want to consider is the trial of Kyprolis plus filanesib (ARRY-520). All the participants in the trial will get Kyprolis; two thirds will also get Kyprolis in combination with filanesib. For the third who don't get filanesib, they will have the option of going on to the drug if Kyprolis alone is not enough to control their myeloma.
You can find a description of the trial here:
http://www.filanesibtrials.com/trials/array-520-216/array-520-216-trial-details/
The page also has a link to the description of the trial at clinicaltrials.gov.
(Full disclosure: Array BioPharma, which is developing filanesib and is sponsor of the trial I just mentioned, is also a sponsor of The Myeloma Beacon.)
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Boris Simkovich - Name: Boris Simkovich
Founder
The Myeloma Beacon
Re: Kyprolis clinical trial - heart & travel questions
Thanks Boris,
I am getting a current SPEP to understand better just what my level of disease progression is at this moment in time. One of my concerns about being in a trial is receiving a higher dose of Kyprolis than I need at this time, and the impact to quality of life and no option to go to maintenance dose levels. I can still do a lot at this time.
I am also concerned about the potential heart problem side effects seen in previous Kyprolis trials and the drug causing problems that could prevent future treatment options, including a second SCT. Do these heart problems go away or are they permanent?
Then again, if I need to have high-dose Kyprolis because of disease progression, the trial will convert you over to the higher dose arm so I could get a higher dose if I need it than I could get outside of the trial. The trial also does a lot of heart monitoring not routinely done otherwise with Kyprolis administration, so there is a lot to think about.
I will ask about the availability of the ARRY-520, but I suspect it is not available through my HMO. Kyprolis is a really good option at this time, but I am mostly concerned about receiving a higher dose that I really may need and the potential complications from that.
I am getting a current SPEP to understand better just what my level of disease progression is at this moment in time. One of my concerns about being in a trial is receiving a higher dose of Kyprolis than I need at this time, and the impact to quality of life and no option to go to maintenance dose levels. I can still do a lot at this time.
I am also concerned about the potential heart problem side effects seen in previous Kyprolis trials and the drug causing problems that could prevent future treatment options, including a second SCT. Do these heart problems go away or are they permanent?
Then again, if I need to have high-dose Kyprolis because of disease progression, the trial will convert you over to the higher dose arm so I could get a higher dose if I need it than I could get outside of the trial. The trial also does a lot of heart monitoring not routinely done otherwise with Kyprolis administration, so there is a lot to think about.
I will ask about the availability of the ARRY-520, but I suspect it is not available through my HMO. Kyprolis is a really good option at this time, but I am mostly concerned about receiving a higher dose that I really may need and the potential complications from that.
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Eric Hofacket - Name: Eric H
- When were you/they diagnosed?: 01 April 2011
- Age at diagnosis: 44
Re: Kyprolis clinical trial - heart & travel questions
Hey Eric,
Even if the trials you are considering don't put you on Kyprolis maintenance therapy, it may be possible to get your doctor to prescribe you Kyprolis maintenance therapy after you are done with the trial. Now, whether your HMO will cover it is a completely different issue. Since Kyprolis maintenance hasn't been tested very much, it may be difficult to get approval for maintenance outside of a trial. But you never know.
Also, you probably know this, but just in case it's not clear, ARRY-520 is still an unapproved drug. You can only be treated with it if you're in a trial that is testing it. That's not true with Kyprolis (in the U.S.); it was approved by the FDA several years ago.
One thing I'm curious about is why you're considering a trial with Kyprolis, rather than a trial with a drug that's not yet approved. For example, in addition to ARRY-520, you also could consider a trial involving one of the new monoclonal antibodies, such as daratumumab or SAR650984, or perhaps even one of the new proteasome inhibitors, such as ixazomib (which is oral), or marizomib, which seems quite promising, but which might not be available outside of a clinical trial for several years.
Even if the trials you are considering don't put you on Kyprolis maintenance therapy, it may be possible to get your doctor to prescribe you Kyprolis maintenance therapy after you are done with the trial. Now, whether your HMO will cover it is a completely different issue. Since Kyprolis maintenance hasn't been tested very much, it may be difficult to get approval for maintenance outside of a trial. But you never know.
Also, you probably know this, but just in case it's not clear, ARRY-520 is still an unapproved drug. You can only be treated with it if you're in a trial that is testing it. That's not true with Kyprolis (in the U.S.); it was approved by the FDA several years ago.
One thing I'm curious about is why you're considering a trial with Kyprolis, rather than a trial with a drug that's not yet approved. For example, in addition to ARRY-520, you also could consider a trial involving one of the new monoclonal antibodies, such as daratumumab or SAR650984, or perhaps even one of the new proteasome inhibitors, such as ixazomib (which is oral), or marizomib, which seems quite promising, but which might not be available outside of a clinical trial for several years.
Re: Kyprolis clinical trial - heart & travel questions
Eric,
I wanted to share my experience with Kyprolis. I had Kyprolis five months after my first stem cell transplant During the first cycle, I felt really awful. I was exhausted and my whole body felt really battered. I would not have been able to travel anywhere.
However, the FLCs were halved so we started the second cycle at a twenty five percent higher dose. The discomfort continued and on the last two days of the cycle I had angina for the first time in my life. There was no change in the FLCs so the treatment was stopped.
For me Kyprolis was the worst part of my treatment to date, and my treatment has included Velcade, Revlimid, vorinostat, and two stem cell transplants. My heart was not monitored during the treatment but a heart ultrasound before the second transplant showed no abnormalities. Obviously, other patients have tolerated this drug better than I did. I may be an exception, I hope so. If a lower dose would work, it seems like a much better option for you. I hope you can get the information you need.
I'm pleased to learn from other posts about the travel restrictions in clinical trials. I love to travel and have arranged my chemo around trips and holidays whenever possible.
Bluebell
I wanted to share my experience with Kyprolis. I had Kyprolis five months after my first stem cell transplant During the first cycle, I felt really awful. I was exhausted and my whole body felt really battered. I would not have been able to travel anywhere.
However, the FLCs were halved so we started the second cycle at a twenty five percent higher dose. The discomfort continued and on the last two days of the cycle I had angina for the first time in my life. There was no change in the FLCs so the treatment was stopped.
For me Kyprolis was the worst part of my treatment to date, and my treatment has included Velcade, Revlimid, vorinostat, and two stem cell transplants. My heart was not monitored during the treatment but a heart ultrasound before the second transplant showed no abnormalities. Obviously, other patients have tolerated this drug better than I did. I may be an exception, I hope so. If a lower dose would work, it seems like a much better option for you. I hope you can get the information you need.
I'm pleased to learn from other posts about the travel restrictions in clinical trials. I love to travel and have arranged my chemo around trips and holidays whenever possible.
Bluebell
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bluebell
Re: Kyprolis clinical trial - heart & travel questions
TerryH,
I know that even if I do not sign up for the SWOG S1304 trial, my oncologist plans to use Kyprolis for my next line of therapy. A big consideration as you point out is maintenance therapy. Nothing about this trial is maintenance therapy and the trial wants the participants to stay on it for 12 months. The two arms are the current approved full dose and a higher dose to test the effectiveness and safety at the higher dose level.
I had been on Revlimid maintenance therapy that gradually turned into full-dose Revlimid and dexamethasone used in initial induction therapy. Is my disease progressing to the point where I need the level treatment used initial therapy or do I just need to switch to a better maintenance therapy?
I have been cycling, swimming and snow skiing. Twelve months of Kyprolis will likely put an end to my ability to do this level of activity. But then again maybe any level of treatment beyond what I had been doing is going to affect what I can do and my quality of life going forward, and I need to reset my expectations.
I only lasted about 4.5 cycles of Velcade before I had to be pulled of that therapy because of complications. Can I expect to make it through 12 cycles of Kyprolis? I am doubtful and on a trial they do not want you to dial back the dosage to maintenance levels.
If I had hard case refractory myeloma, the trial makes a lot of sense. I would need aggressive treatment and I could get Kyprolis at a dose higher than other wise approved by the FDA if I needed it. But I do not know I am in that position yet. My thinking now though is I just need a better maintenance therapy for the moment but I need to discuss this more with my oncologist.
Bluebell, Melanie, Micallie, Rumnting, and Dano, thanks for your responses and feedback on your experiences with Kyprolis. I will consider all this in deciding what to do. Like a lot of myeloma treatments your experiences are not all the same.
Danno,
I was on Revlimid maintenance and it was starting to lose effectiveness. I agree Revlimid seems to be the easiest drug for maintenance therapy but the time for that seems to be passing for me.
Micallie,
I do not have to be on a trial to get Kyprolis but the choice is being offered to me. The advantages of the trial are close monitoring, especially of the heart and PET scans, to more closely track disease progression. The disadvantage as you said is more restrictions and a trial is not a treatment tailored to an individual’s case.
Melanie,
My oncologist told me today that in my HMO it is not standard practice to monitor the heart while on Kyprolis, that is only done if I participate in this trial or unless there is a clear need to start doing so. I am thinking though based on others experiences that maybe some level of heart assessment should be done as standard practice.
I know that even if I do not sign up for the SWOG S1304 trial, my oncologist plans to use Kyprolis for my next line of therapy. A big consideration as you point out is maintenance therapy. Nothing about this trial is maintenance therapy and the trial wants the participants to stay on it for 12 months. The two arms are the current approved full dose and a higher dose to test the effectiveness and safety at the higher dose level.
I had been on Revlimid maintenance therapy that gradually turned into full-dose Revlimid and dexamethasone used in initial induction therapy. Is my disease progressing to the point where I need the level treatment used initial therapy or do I just need to switch to a better maintenance therapy?
I have been cycling, swimming and snow skiing. Twelve months of Kyprolis will likely put an end to my ability to do this level of activity. But then again maybe any level of treatment beyond what I had been doing is going to affect what I can do and my quality of life going forward, and I need to reset my expectations.
I only lasted about 4.5 cycles of Velcade before I had to be pulled of that therapy because of complications. Can I expect to make it through 12 cycles of Kyprolis? I am doubtful and on a trial they do not want you to dial back the dosage to maintenance levels.
If I had hard case refractory myeloma, the trial makes a lot of sense. I would need aggressive treatment and I could get Kyprolis at a dose higher than other wise approved by the FDA if I needed it. But I do not know I am in that position yet. My thinking now though is I just need a better maintenance therapy for the moment but I need to discuss this more with my oncologist.
Bluebell, Melanie, Micallie, Rumnting, and Dano, thanks for your responses and feedback on your experiences with Kyprolis. I will consider all this in deciding what to do. Like a lot of myeloma treatments your experiences are not all the same.
Danno,
I was on Revlimid maintenance and it was starting to lose effectiveness. I agree Revlimid seems to be the easiest drug for maintenance therapy but the time for that seems to be passing for me.
Micallie,
I do not have to be on a trial to get Kyprolis but the choice is being offered to me. The advantages of the trial are close monitoring, especially of the heart and PET scans, to more closely track disease progression. The disadvantage as you said is more restrictions and a trial is not a treatment tailored to an individual’s case.
Melanie,
My oncologist told me today that in my HMO it is not standard practice to monitor the heart while on Kyprolis, that is only done if I participate in this trial or unless there is a clear need to start doing so. I am thinking though based on others experiences that maybe some level of heart assessment should be done as standard practice.
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Eric Hofacket - Name: Eric H
- When were you/they diagnosed?: 01 April 2011
- Age at diagnosis: 44
15 posts
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