The specialist I saw today at University of Maryland says I need to start treatment now. (Going for one more opinion in a couple of weeks at Hopkins). My high-risk smoldering myeloma is clearly evolving.
I have looked into the clinical trials at NIH with Dr. Landgren (who, by the way is moving to NY!) as well as considered treatment near home. The treatment at home would be Velcade-Revlimid-Dex and the clinical trial would be Kyprolis-Revlimid-Dex.
The dilemma I have is that in order to do the trial, I have to drive 70 miles each way and go through ALL the testing that I just had done (PET,BM biopsy, (ouch!), blood work, etc). OR I can start treatment 8 miles from home (4 cycles, harvest stem cells, etc)
My insurance is not an issue for treatment at home. I was told Kyprolis may have better response than Velcade, so is it worth it?
The UofM specialist also mentioned SCT very soon, which I don't think I can do during a clinical trial, right? He STRONGLY feels I need SCT to nip this disease in the bud. Too much too soon?
Opinions greatly appreciated!
Forums
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gardengirl - Name: gardengirl
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Nov. 2013
- Age at diagnosis: 47
Re: Trial or standard therapy for high-risk smoldering?
Tough choices.
Here are a few thoughts to help get a discussion going.
I guess I wouldn't personally let the convenience of access to a treatment facility enter into my thought process and would instead just think about what the best outcome could be for me in the end.
What does Dr. Landgren say about an ASCT in your situation? I really don't think he would bias you to do a drug-only trial if he didn't think it was in your best interest. It's not like he is anti-ASCT in his overall philosophy, but he is starting to question it as a frontline therapy for symptomatic multiple myeloma patients. I also think he also has good reason to choose Kyprolis over Velcade for his high risk SMM trial...did you ask him why he chose a CRd regiment over VRd or some other cocktail for his trial?
I think I would personally choose the trial with CRd over the VRd route and certainly over ASCT, if only based on QOL issues (less chance of PN with CRd. I won't bother re-opening another ASCT debate here...you already know my general opinion of ASCTs, so no reason to revisit that subject in this response).
You can always transition to VRd (covered by insurance as a frontline treatment) if you become R/R with the CRd (not covered as a frontline treatment under insurance) therapy.
Here are a few thoughts to help get a discussion going.
I guess I wouldn't personally let the convenience of access to a treatment facility enter into my thought process and would instead just think about what the best outcome could be for me in the end.
What does Dr. Landgren say about an ASCT in your situation? I really don't think he would bias you to do a drug-only trial if he didn't think it was in your best interest. It's not like he is anti-ASCT in his overall philosophy, but he is starting to question it as a frontline therapy for symptomatic multiple myeloma patients. I also think he also has good reason to choose Kyprolis over Velcade for his high risk SMM trial...did you ask him why he chose a CRd regiment over VRd or some other cocktail for his trial?
I think I would personally choose the trial with CRd over the VRd route and certainly over ASCT, if only based on QOL issues (less chance of PN with CRd. I won't bother re-opening another ASCT debate here...you already know my general opinion of ASCTs, so no reason to revisit that subject in this response).
You can always transition to VRd (covered by insurance as a frontline treatment) if you become R/R with the CRd (not covered as a frontline treatment under insurance) therapy.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Trial or standard therapy for high-risk smoldering?
Thanks, Multibilly! I really do appreciate everyone's personal opinions! I am actually waiting for the study coordinator to get back to me. She said there are issues enrolling new patients now that Dr. Landgren is moving. But now that treatment is in my immediate future, I want to educate myself on all options. I will have to find the threads for the debates on SCT as frontline therapy (and maybe reopen them!). Apparently we will be snowed in tomorrow, so that will give me some time!
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gardengirl - Name: gardengirl
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Nov. 2013
- Age at diagnosis: 47
Re: Trial or standard therapy for high-risk smoldering?
That is a tough choice. Just reading about either VRD or KRD, they both seem to have better efficacy than other choices. Velcade and Kyprolis are both selective proteasome inhibitors. I conjecture they work in a similar fashion.
Please keep us updated on your choice and how it is working. Best wishes.
Please keep us updated on your choice and how it is working. Best wishes.
Re: Trial or standard therapy for high-risk smoldering?
You can find quite a bit of discussion about using CRd as a frontline therapy. This summarizes one of the initial analyses without a lot of technical jargon.
http://www.hematology.org/News/2012/8422.aspx
The summary ties it all together and fairly well sums up why I would seriously consider CRd, in addition to the lessened chances of PN that I mentioned earlier.
"...Our final results continue to demonstrate the efficacy and safety of carfilzomib when combined with lenalidomide and dexamethasone,” said Dr. Jakubowiak. “Our data support the potential for CRd as a new frontline treatment option for patients with multiple myeloma with results that are comparable to or better than those achieved with other established frontline regimens followed by high-dose chemotherapy and stem cell transplant.”
I would also suggest going through the ASH 2013 presentations on the subject. The above is just one doctor's opinion. I trust you already saw this recent Beacon article?
https://myelomabeacon.org/news/2014/01/28/kyprolis-carfilzomib-ash-2013/
It's good to have choices....
http://www.hematology.org/News/2012/8422.aspx
The summary ties it all together and fairly well sums up why I would seriously consider CRd, in addition to the lessened chances of PN that I mentioned earlier.
"...Our final results continue to demonstrate the efficacy and safety of carfilzomib when combined with lenalidomide and dexamethasone,” said Dr. Jakubowiak. “Our data support the potential for CRd as a new frontline treatment option for patients with multiple myeloma with results that are comparable to or better than those achieved with other established frontline regimens followed by high-dose chemotherapy and stem cell transplant.”
I would also suggest going through the ASH 2013 presentations on the subject. The above is just one doctor's opinion. I trust you already saw this recent Beacon article?
https://myelomabeacon.org/news/2014/01/28/kyprolis-carfilzomib-ash-2013/
It's good to have choices....
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Trial or standard therapy for high-risk smoldering?
Hi,
I agree that you have a difficult decision before you. I am a participant in the NIH High Risk Smoldering C/R/D trial. I have been on maintenance for 8 months now and achieved MRD negative status with the treatment. I did have a stem cell collection after the 6th cycle and it's good to know that those cells are frozen and available indefinitely if I ever need a SCT. I'm hoping my early treatment decision will eliminate or significantly delay the need for a SCT.
Overall, i tolerated the treatment well. It was not convenient. I live in rural WV and traveled 90 miles to the airport three times a month, flew for a little over an hour, then caught the metro to the shuttle stop and waited outside in all types of weather to catch the van to go to the hotel. The only method of travel i didn't take was by boat. (or bicycle) Was it worth it? I hope that time will tell that it was. I chose to start treatment now while i felt well enough to deal with the travel, etc...
My story is not uncommon as I met people who traveled from all over the country to have their treatment at the NIH. The NIH did help with travel arrangement and expenses. If you are healthy enough now to travel, don't let distance be the deciding factor in your choice of treatment. Choose what you and your myeloma specialists determine will be best for you.
Best Wishes.
I agree that you have a difficult decision before you. I am a participant in the NIH High Risk Smoldering C/R/D trial. I have been on maintenance for 8 months now and achieved MRD negative status with the treatment. I did have a stem cell collection after the 6th cycle and it's good to know that those cells are frozen and available indefinitely if I ever need a SCT. I'm hoping my early treatment decision will eliminate or significantly delay the need for a SCT.
Overall, i tolerated the treatment well. It was not convenient. I live in rural WV and traveled 90 miles to the airport three times a month, flew for a little over an hour, then caught the metro to the shuttle stop and waited outside in all types of weather to catch the van to go to the hotel. The only method of travel i didn't take was by boat. (or bicycle) Was it worth it? I hope that time will tell that it was. I chose to start treatment now while i felt well enough to deal with the travel, etc...
My story is not uncommon as I met people who traveled from all over the country to have their treatment at the NIH. The NIH did help with travel arrangement and expenses. If you are healthy enough now to travel, don't let distance be the deciding factor in your choice of treatment. Choose what you and your myeloma specialists determine will be best for you.
Best Wishes.
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kcarrollfnp
Re: Trial or standard therapy for high-risk smoldering?
You might also find this article to be helpful.
http://asheducationbook.hematologylibrary.org/content/2012/1/354.long
Of note, is this paragraph:
In high-risk patients, even regimens such as total therapy 3, which contains VCD/VTD, double ASCT, and routine maintenance therapy, have failed to improve outcomes to levels achieved in standard- and intermediate-risk patients. Therefore, it is reasonable to consider VRD as initial therapy with a goal of achieving CR and sustaining it.
Also note that this was written just before some of the newer CRd results had come out (but Dr. Rajkumar does mention the promise of CRd in the emerging options section).
http://asheducationbook.hematologylibrary.org/content/2012/1/354.long
Of note, is this paragraph:
In high-risk patients, even regimens such as total therapy 3, which contains VCD/VTD, double ASCT, and routine maintenance therapy, have failed to improve outcomes to levels achieved in standard- and intermediate-risk patients. Therefore, it is reasonable to consider VRD as initial therapy with a goal of achieving CR and sustaining it.
Also note that this was written just before some of the newer CRd results had come out (but Dr. Rajkumar does mention the promise of CRd in the emerging options section).
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Trial or standard therapy for high-risk smoldering?
Interesting topic.
4 and 1/2 years ago, the overwhelming majority of multiple myeloma specialists saw ASCTs as a needed form of therapy in those that are healthy enough to tolerate it.
I'm sure the "needle of opinion" has moved towards eliminating the need for an ASCT. But I'd be willing to bet more than 80%??? would still recommend the ASCT.
Since I was not very responsive to all of the pretreatment, I did back to back ASCT's and am very happy I did it.
(I have to admit, I don't know where Smoldering fits in to the decision tree).
4 and 1/2 years ago, the overwhelming majority of multiple myeloma specialists saw ASCTs as a needed form of therapy in those that are healthy enough to tolerate it.
I'm sure the "needle of opinion" has moved towards eliminating the need for an ASCT. But I'd be willing to bet more than 80%??? would still recommend the ASCT.
Since I was not very responsive to all of the pretreatment, I did back to back ASCT's and am very happy I did it.
(I have to admit, I don't know where Smoldering fits in to the decision tree).
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stann
Re: Trial or standard therapy for high-risk smoldering?
Thanks for all the responses. I saw the specialist 2 days ago and when I asked him if they do SCT on high-risk smoldering, he said I am stage 1 myeloma. What? There's that gray-line! I do not have any CRAB sxs, but my kappa is crazy high and he said I can go into acute kidney failure. I think he really feels that since I'm evolving, it's just going to continue exponentially. I will see what the specialist at Hopkins says. I am willing to do whatever it takes to prolong survival, even if it involves a few months of misery! 
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gardengirl - Name: gardengirl
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Nov. 2013
- Age at diagnosis: 47
Re: Trial or standard therapy for high-risk smoldering?
There are more studies coming out on the topic of chemo-only treatment versus ASCT. This is a recent paper from ASH 2013 on a study comparing the two in newly diagnosed patients. It doesn't specifically break out an analysis of high risk patients.
https://myelomabeacon.org/resources/mtgs/ash2013/abs/3180/
As you look at these results, you need to ask what they key metric is for your particular situation. For me, it is OS, but for others it may be different. QOL is another extremely key component for me, but this is not typically addressed very well in studies.
PFS and OS are summarized here:
Median PFS for LD+ASCT versus LD was 17.0 months (95% CI 15.5–not estimable) versus 25.2 months (95% CI 9.0–not estimable; p=0.94)
Median OS for LD+ASCT versus LD was 57.6 months (95% CI 48.0–not estimable) versus not reached (p=0.94).
Note that only the ASCT arm had a sufficient mortality rate to calculate the median OS stat (being blunt, not enough of the chemo-only patients died to produce a median OS stat at the time the study was presented).
There was a couple of comments on this when I posted the link before.
https://myelomabeacon.org/forum/latest-study-on-chemo-only-versus-asct-t2620.html
https://myelomabeacon.org/resources/mtgs/ash2013/abs/3180/
As you look at these results, you need to ask what they key metric is for your particular situation. For me, it is OS, but for others it may be different. QOL is another extremely key component for me, but this is not typically addressed very well in studies.
PFS and OS are summarized here:
Median PFS for LD+ASCT versus LD was 17.0 months (95% CI 15.5–not estimable) versus 25.2 months (95% CI 9.0–not estimable; p=0.94)
Median OS for LD+ASCT versus LD was 57.6 months (95% CI 48.0–not estimable) versus not reached (p=0.94).
Note that only the ASCT arm had a sufficient mortality rate to calculate the median OS stat (being blunt, not enough of the chemo-only patients died to produce a median OS stat at the time the study was presented).
There was a couple of comments on this when I posted the link before.
https://myelomabeacon.org/forum/latest-study-on-chemo-only-versus-asct-t2620.html
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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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