I have a number of questions pertaining to the following scenario:
Dx with IGA Kappa Myeloma in June 2010. CyborD 3 cycles achieved CR. SCT in October of 2010 achieved sCR with negative minimal residual disease on flow cytometry. 5mg Rev maintenance since that time. Bence Jones proteins appeared in June 2013 at 30 mg/24 hr. And, an m-spike of .5 g/dL appeared in the serum. Since June, the Rev maintenance was bumped to 10 mg. The serum m-spike has dropped to .4 g/dL and the urine m-spike is at 100 mg/24 hr. My questions are as follows:
1. Given that the numbers are fairly low, is this disease progression?
2. When calculating PFS, what is the starting and end point?
3. I know that there is a benefit to maintaining a CR for 3 or more years. Does this scenario qualify for maintaining CR for three years?
4. Does progression on a low dose (5 or 10mg) Revlimid maintenance indicate resistance to Revlimid if it were used as a retreatment at 25mg?
5. Is is possible for a very low m-spike to reappear from CR and then stall in an MGUS-like state for an extended period of time?
6. Where does one draw the line with watch-and-wait vs. restart treatment in this scenario?
7. Has anyone had a similar scenario?
Thank you for your help.
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Re: Questions regarding progression / restarting treatment
Hi Perseverance, I couldn't answer most of your questions, but in answer to #5, yes I think that a low M spike level can reappear and then not progress, at least not for awhile. In my situation, not being on meds at this time, I would be monitored for a low level of 'M' protein, until such time as it was deemed ready to treat. Typically, I think that would be at about 1.0 g/dl. (In Canada, 10 mg/dl). Other factors on the watch and wait strategy would be other factors, such as whether or not bone damage is (re)occurring, whether the kidneys are compromised, and all other sorts of parameters that are measured with myeloma. Hope that helps!
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Questions regarding progression / restarting treatment
This is a handy document to use to understand concepts like complete response, partial response, relapse, etc., when it comes to myeloma:
http://bloodjournal.hematologylibrary.org/content/117/18/4691.full.pdf
You'll see in the document that progression free survival is defined as "Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first."
This raises the question: What's the definition of disease progression in myeloma?
The document doesn't come right out and answer that question. But I believe "disease progression" is basically when a patient experiences "progressive disease", and there are a bunch of different criteria for that in the document.
Basically, though, the definition of progression is whenever your M-spike increases more than 25 percent from its lowest level.
See the last column of Table 1 (the column labeled "PD") in the document for all the details.
Progression, however, is not the same as relapse. "Relapsed myeloma is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy ..."
http://bloodjournal.hematologylibrary.org/content/117/18/4691.full.pdf
You'll see in the document that progression free survival is defined as "Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first."
This raises the question: What's the definition of disease progression in myeloma?
The document doesn't come right out and answer that question. But I believe "disease progression" is basically when a patient experiences "progressive disease", and there are a bunch of different criteria for that in the document.
Basically, though, the definition of progression is whenever your M-spike increases more than 25 percent from its lowest level.
See the last column of Table 1 (the column labeled "PD") in the document for all the details.
Progression, however, is not the same as relapse. "Relapsed myeloma is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy ..."
Re: Questions regarding progression / restarting treatment
Excellent questions:
Table 1 in the reference Terry provided gives a nice summary of definitions of progression. Technically speaking, this would classify.
PFS: definition can vary but generally is the time from the date of start of therapy to date of identified progression or death from any cause
seems to be close to 3 years in CR.
There can be benefit to increasing Revlimid dose. I also consider reintroducing dexamethasone.
Regarding the MGUS like state: This does happen. Provided there is not evidence for end organ damage, it is very resonalbe to continue the current treatment and monitor.
I don't change therapy unless there is an ongoing trend upward in the disease markers or unless there is new end organ damage. The other lab to check as a marker of disease would be free light chains. It seems in your case reasonable to continue what you are doing.
hope this helps.
Table 1 in the reference Terry provided gives a nice summary of definitions of progression. Technically speaking, this would classify.
PFS: definition can vary but generally is the time from the date of start of therapy to date of identified progression or death from any cause
seems to be close to 3 years in CR.
There can be benefit to increasing Revlimid dose. I also consider reintroducing dexamethasone.
Regarding the MGUS like state: This does happen. Provided there is not evidence for end organ damage, it is very resonalbe to continue the current treatment and monitor.
I don't change therapy unless there is an ongoing trend upward in the disease markers or unless there is new end organ damage. The other lab to check as a marker of disease would be free light chains. It seems in your case reasonable to continue what you are doing.
hope this helps.
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Dr. Jason Valent - Name: Jason Valent, M.D.
Beacon Medical Advisor
Re: Questions regarding progression / restarting treatment
Thanks for the replies.
Couple other questions:
Does progression on Revlimid maintenance have an effect on using Revlimid as a primary therapy in the future? Are there studies on this?
Has anyone here had the experience (doctor or patient) with going from CR to very low m-spike and then maintaining MGUS like state for an extended period of time?
Couple other questions:
Does progression on Revlimid maintenance have an effect on using Revlimid as a primary therapy in the future? Are there studies on this?
Has anyone here had the experience (doctor or patient) with going from CR to very low m-spike and then maintaining MGUS like state for an extended period of time?
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Perseverance - When were you/they diagnosed?: 2010
Re: Questions regarding progression / restarting treatment
I went from CR, with no maintenance, in 9 months. Then my m-spike gradually increased over the next 1 1/2 years when I restarted Rev 15 mg Dex 20 mg. When I first began to have an m-spike again my oncologist said that we would watch and wait. He set a level of 1.5 as when we would restart treatment.
I had to wait a few months longer from the time that my oncologist wanted to restart treatment to when I did because I was scheduled for joint replacement surgery during that time. By the time that I actually restarted treatment, my m-spike had increased a lot. My oncologist started me on the Rev and Dex and told me that if my numbers didn't improve below 2.5 by my next appointment that he would add Velcade into the mix. Well the m-spike dropped to 1.4 from 3.7 in 6 weeks and has been gradually dropping with each 6 week visit since last Jan.
So, an increase in the Rev with the addition of Dex might do the trick. If not, your oncologist might consider a combination of something else with the Rev and Dex. Talk with your oncologist and ask what his/her thinking/plan is.
The best to you,
Nancy in Phila
I had to wait a few months longer from the time that my oncologist wanted to restart treatment to when I did because I was scheduled for joint replacement surgery during that time. By the time that I actually restarted treatment, my m-spike had increased a lot. My oncologist started me on the Rev and Dex and told me that if my numbers didn't improve below 2.5 by my next appointment that he would add Velcade into the mix. Well the m-spike dropped to 1.4 from 3.7 in 6 weeks and has been gradually dropping with each 6 week visit since last Jan.
So, an increase in the Rev with the addition of Dex might do the trick. If not, your oncologist might consider a combination of something else with the Rev and Dex. Talk with your oncologist and ask what his/her thinking/plan is.
The best to you,
Nancy in Phila
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NStewart - Name: Nancy Stewart
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 3/08
- Age at diagnosis: 60
6 posts
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