Question: Should we not do maintenance therapy?
Background: My husband, 48, was diagnosed with multiple myeloma in May, 2015. At time of diagnosis, he had an M-spike of 2.2, 30% cells in the bone marrow, IGA Kappa, and a lot of bone involvement. He had 3 compression fractures at the time of diagnosis. No chromosomal abnormalities. Stage IIIA on Salmon Durie, Stage 1 on ISS.
Treatment was standard of care. 6 - 8 cycles of RVD. He reached a VGPR with an M-spike of 0.2. Had auto-SCT with high-dose melphalen. Latest results show MRD negative so 0% cells from BMB and 0.1 M-spike. 90 days post SCT still at VGPR.
Our myeloma specialist said given my husband is standard risk, he could suggest to hold off on maintenance with Revlimid.
Rev maintenance pros - perhaps longer time to first relapse.
Rev maintenance cons - some increased chance of secondary cancers. Sooner relapse but may not affect OS.
We are thinking of NOT doing maintenance. But, would keeping myeloma pounded be a good thing? Studies still debate on if there is an advantage to OS.
Any thoughts or other considerations?
Thank you. I love this forum and always get great perspective.
Forums
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Re: Revlimid Maintenance Decision
I have been in remission and on Revlimid for 5 years. I was just diagnosed with Melanoma stage 3 so t.his will be a new journey for me. I highly support Revlimid even with side effects.
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texas-tea13 - Name: Steve
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: 09/19/2009
- Age at diagnosis: 59
Re: Revlimid Maintenance Decision
Hello Irankin:
Wanted to quickly address your point on OS with maintenance, a topic that I have posted on in the past, so some of the more experienced readers may want to pass at me saying the same thing, again (sorry about that). There were studies on maintenance with OS that were inconclusive. Those studies did tend to show longer PFS, however, less conclusive OS. The thing with those older studies, however, is that they used older induction regimens with a poorer initial response (for example Vincristine, Adromycin and Dex, aka VAD). Based on those studies, many doctors felt that getting the improved PFS was good enough, and my non-formal observation from this forum and other readings is that maintenance has increased by a healthy degree in the last two or three years.
Those older studies did not use RVD or CyborD to a great degree. The newer induction regimens have a better "base" from which to start. It is important to note that it takes time for the data to become ripe. For instance, RVD and CyBorD have become the standard of care only in about the last 5 to 6 years. Since OS of these regimens are in the range of about 7 years, it will take some time to get hard data.
There is a large study run by the Cal-GB group on maintenance vs no maintenance. That study has been publishing results for a couple of years. Earlier publications (say last year) did not clearly show an OS survival benefit. Those prior results though, were incomplete based on the time period being too short. They did not conclude the two approaches were equal, they just did not have enough data. This year at the ASCO meeting, the updated results for the first time showed a statistically superior result of OS for maintenance. Trying to write this from memory, no maintenance was something like 66 months OS, and the Rev maintenance arm was approaching 80 months, with the medium not yet reached. The study authors concluded and advised that this was clearly statistically superior, and that sounds right to me.
The point is that this was the one and only study with good induction and ASCT comparing maintenance vs no maintenance and it shows a superiority to maintenance. Other studies that showed inconclusive OS on maintenance had mostly obsolete induction regimens, and basically no longer apply well to the question.
There is another study (Dana Farber and IFM) that primarily is comparing early vs delayed ASCT, but also has a Rev maintenance component to it. I have read doctors say that the Rev arm (just published at ASH) showed superior OS, but I have also read other doctors state that it was inconclusive. The doctor who I think was most right stated that the result slightly favored Rev maintenance, but the data is not yet ripe. Both of these studies will have data updates periodically over the next few years. The thing is however, you need to make a decision now.
Keep in mind that study results are on populations, and is not a perfect indicator of individual's results. Even if you agree with the Cal-GB study, there is not a good enough test right now to show whether or not you really need the maintenance. So at the end of the day, its a judgement call, whether or not you think that going med free for a time is valuable for you, or you want to play the averages (and go with maintenance).
Lastly, I am noticing that you mentioned that your husband was MRD -, but still had a low M-Spike. I am beginning to notice that a few people are like that, and I am not quite sure what that means. In theory, the MRD - test is supposed to be more sensitive, but apparently not in all cases. My wife was not in exactly your situation, but she did have a very low (but detectable) level of myeloma cells on the BMB, but almost non-detect, but the M-Spike got down to about 0.15. We are trying a consolidation (post-ASCT) at present, to try and get it to zero.
Good luck in making the decision. Rgds
Wanted to quickly address your point on OS with maintenance, a topic that I have posted on in the past, so some of the more experienced readers may want to pass at me saying the same thing, again (sorry about that). There were studies on maintenance with OS that were inconclusive. Those studies did tend to show longer PFS, however, less conclusive OS. The thing with those older studies, however, is that they used older induction regimens with a poorer initial response (for example Vincristine, Adromycin and Dex, aka VAD). Based on those studies, many doctors felt that getting the improved PFS was good enough, and my non-formal observation from this forum and other readings is that maintenance has increased by a healthy degree in the last two or three years.
Those older studies did not use RVD or CyborD to a great degree. The newer induction regimens have a better "base" from which to start. It is important to note that it takes time for the data to become ripe. For instance, RVD and CyBorD have become the standard of care only in about the last 5 to 6 years. Since OS of these regimens are in the range of about 7 years, it will take some time to get hard data.
There is a large study run by the Cal-GB group on maintenance vs no maintenance. That study has been publishing results for a couple of years. Earlier publications (say last year) did not clearly show an OS survival benefit. Those prior results though, were incomplete based on the time period being too short. They did not conclude the two approaches were equal, they just did not have enough data. This year at the ASCO meeting, the updated results for the first time showed a statistically superior result of OS for maintenance. Trying to write this from memory, no maintenance was something like 66 months OS, and the Rev maintenance arm was approaching 80 months, with the medium not yet reached. The study authors concluded and advised that this was clearly statistically superior, and that sounds right to me.
The point is that this was the one and only study with good induction and ASCT comparing maintenance vs no maintenance and it shows a superiority to maintenance. Other studies that showed inconclusive OS on maintenance had mostly obsolete induction regimens, and basically no longer apply well to the question.
There is another study (Dana Farber and IFM) that primarily is comparing early vs delayed ASCT, but also has a Rev maintenance component to it. I have read doctors say that the Rev arm (just published at ASH) showed superior OS, but I have also read other doctors state that it was inconclusive. The doctor who I think was most right stated that the result slightly favored Rev maintenance, but the data is not yet ripe. Both of these studies will have data updates periodically over the next few years. The thing is however, you need to make a decision now.
Keep in mind that study results are on populations, and is not a perfect indicator of individual's results. Even if you agree with the Cal-GB study, there is not a good enough test right now to show whether or not you really need the maintenance. So at the end of the day, its a judgement call, whether or not you think that going med free for a time is valuable for you, or you want to play the averages (and go with maintenance).
Lastly, I am noticing that you mentioned that your husband was MRD -, but still had a low M-Spike. I am beginning to notice that a few people are like that, and I am not quite sure what that means. In theory, the MRD - test is supposed to be more sensitive, but apparently not in all cases. My wife was not in exactly your situation, but she did have a very low (but detectable) level of myeloma cells on the BMB, but almost non-detect, but the M-Spike got down to about 0.15. We are trying a consolidation (post-ASCT) at present, to try and get it to zero.
Good luck in making the decision. Rgds
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JPC - Name: JPC
Re: Revlimid Maintenance Decision
Thank you both for replying and your thoughts. I hope to hear from more people, as well.
My biggest fear is a secondary cancer, especially AML/MDS. the other fear is we make the wrong choice that would impact his overall survival, if the secondary cancer "scare" is really minimal. The largest % I have seen is 7% of Revlimid users who had high dose melphalan get a secondary cancer.
But I don't know if saying 93% of patients don't get a secondary cancer is a way to look at it when the magnitude of the 7% is high stakes. After all, we already got a rare disease.
I have gotten one doctor's opinion and I think I will get another doctor official opinion and also seek out multiple myeloma docs at a patient and family seminar I am going to.
PLUS, I value this forum. Thank you.
My biggest fear is a secondary cancer, especially AML/MDS. the other fear is we make the wrong choice that would impact his overall survival, if the secondary cancer "scare" is really minimal. The largest % I have seen is 7% of Revlimid users who had high dose melphalan get a secondary cancer.
But I don't know if saying 93% of patients don't get a secondary cancer is a way to look at it when the magnitude of the 7% is high stakes. After all, we already got a rare disease.
I have gotten one doctor's opinion and I think I will get another doctor official opinion and also seek out multiple myeloma docs at a patient and family seminar I am going to.
PLUS, I value this forum. Thank you.
Re: Revlimid Maintenance Decision
As JPC points out, the data is inconclusive. Other things to consider are : the incidence of secondary cancers for those who forego maintenance is not zero--it is about 3%; the secondary cancers seem to be more prevalent with those who have taken melphalan orally rather than intravenously in connection with a transplant.
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goldmine848 - Name: Andrew
- When were you/they diagnosed?: June 2013
- Age at diagnosis: 60
Re: Revlimid Maintenance Decision
Hi Irankin,
I find that watching the two videos in the link below is a good way to quickly get exposed to the highlights a of quite a few studies on the topic of maintenance.
https://myelomabeacon.org/forum/nice-debate-on-pis-versus-imids-for-maintenance-t6489.html
This is a very brief video summary of the latest CALGB/ECOG/BMT CTN 100104 study update that JPC referred to:
https://www.youtube.com/watch?v=AVRJ8BSUFOU
I'm not sure that watching the above videos will leave you with a better idea of which route to pursue, but they do cover a lot of ground without having to sift through all the various studies.
Best of luck with this tough decision....
I find that watching the two videos in the link below is a good way to quickly get exposed to the highlights a of quite a few studies on the topic of maintenance.
https://myelomabeacon.org/forum/nice-debate-on-pis-versus-imids-for-maintenance-t6489.html
This is a very brief video summary of the latest CALGB/ECOG/BMT CTN 100104 study update that JPC referred to:
https://www.youtube.com/watch?v=AVRJ8BSUFOU
I'm not sure that watching the above videos will leave you with a better idea of which route to pursue, but they do cover a lot of ground without having to sift through all the various studies.
Best of luck with this tough decision....
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Revlimid Maintenance Decision
I thought I would weigh in on this discussion, with a suggestion that you investigate Velcade/low dose dex for maintenance. To make a long story short, I was on a maintenance of RVD after my stem cell transplant in October 2014. Had a hard time tolerating the Revlimid, even at 5 mgs. Switched to Velcade/dex maintenance, due to the side effects of Revlimid, in addition to the risks of secondary malignancies. I find this easier to tolerate. Downside is a trip to the doctor every two weeks, so there is that inconvenience. But it is a small price to pay in my book.
Just a thought. Unfortunately, there is not a lot of data on the use of Velcade as maintenance; most of it is focused on Revlimid, I think because of the ease of administration. However, it may not be the best solution for some patients. I wish there were more data on Velcade as maintenance. I did find a few articles, but overwhelmingly, Revlimid is the drug of choice for maintenance. I am hoping that now that ninlaro is available, it may be used as an oral maintenance alternative.
Good luck! I hope you continue to have an excellent response to therapy!
Just a thought. Unfortunately, there is not a lot of data on the use of Velcade as maintenance; most of it is focused on Revlimid, I think because of the ease of administration. However, it may not be the best solution for some patients. I wish there were more data on Velcade as maintenance. I did find a few articles, but overwhelmingly, Revlimid is the drug of choice for maintenance. I am hoping that now that ninlaro is available, it may be used as an oral maintenance alternative.
Good luck! I hope you continue to have an excellent response to therapy!
Re: Revlimid Maintenance Decision
Thank you, Multibilly. Might have to rewatch with all of the acronyms. The second link you provided does not work – says it is no longer there.
Re: Velcade as maintenance – good question. Given my husband had peripheral neuropathy and I feel he is just getting over the leg pain, I hate to have him do Velcade.
Hope to hear from others. Thank you.
Re: Velcade as maintenance – good question. Given my husband had peripheral neuropathy and I feel he is just getting over the leg pain, I hate to have him do Velcade.
Hope to hear from others. Thank you.
Re: Revlimid Maintenance Decision
Irankin,
The second link works for me, so not sure why you don't see it.
https://www.youtube.com/watch?v=AVRJ8BSUFOU
But if for some reason you are having problems, just go to Youtube and search on
"Lenalidomide vs. Placebo for Multiple Myeloma Patients Following a Single ASCT "
The second link works for me, so not sure why you don't see it.
https://www.youtube.com/watch?v=AVRJ8BSUFOU
But if for some reason you are having problems, just go to Youtube and search on
"Lenalidomide vs. Placebo for Multiple Myeloma Patients Following a Single ASCT "
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
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