In reading about Gary Blau's passing and his work,
https://myelomabeacon.org/forum/gary-blau-multiple-myeloma-t3153.html#p17759
http://meetinglibrary.asco.org/content/98797-114
I was surprised to hear that dosing is not really custom tailored to a unique individual based on their age, response, etc? Is this really the case?
It seems like I have read quite a bit on this forum of doctors tweaking of doses for individuals based on their response. Are these ongoing dosage adjustments based on specific response criteria (as Gary was encouraging), or are they simply adjustments that are based on guesses from the doctor based on a given patient a bad reaction, a poor response, etc?
Is it also typical that just about every individual gets the same, standard, "off-the-shelf" starting dose of a given drug cocktail when they start treatment?
I certainly got the impression from one of my multiple myeloma specialist that he custom tailors the selection of many different drugs (old and new) and their dose to each specific individual and routinely tweaks this along the way.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Custom tailored dosing
Hi Multibilly,
It's been my experience that I've been started at the same dosages that I google for a particular drug. In the case of the Velcade, I had some neuropathy and digestive issues, so they dialed it back from 1.3 to 1.0 ( I forget the units of measure ). I think that's a standard dialing back for that drug. After my transplant they gave it at 1.3. I had no issues, but that it wasn't that effective for me.
They just started me on Kyprolis and Pomalyst with dexamethasone. I'm at the highest dosage for Pomalyst (4mg) and the standard starting dose for Kyprolis 20mg/m2. This gets bumped to 27 for following cycles if it's tolerated well. It changes only if a weight change of 20% or more occurs.
I'm thinking that, in the case of these newer drugs, sticking with the tested doses might be a good thing. However, I'd love for them to be able to individualize things more, not just drug dosages.
For example, the plasmacytomas that I had post transplant were noticeable to me in December. I started chemo day 90. The bumps went away for cycle one, but returned in cycle 2. I should have demanded a drug change, but instead I went along with the protocol that said lower the dosage and get Velcade once every other week instead of twice a week because my blood tests were good.
But, if bumps are growing on my skull, why should I try a maintenance dose at that point? But that's what protocol said. Blood numbers good ... proceed to maintenance.
There are so many variables with this disease. It's hard to know what to do. The experts seem confused.
It's been my experience that I've been started at the same dosages that I google for a particular drug. In the case of the Velcade, I had some neuropathy and digestive issues, so they dialed it back from 1.3 to 1.0 ( I forget the units of measure ). I think that's a standard dialing back for that drug. After my transplant they gave it at 1.3. I had no issues, but that it wasn't that effective for me.
They just started me on Kyprolis and Pomalyst with dexamethasone. I'm at the highest dosage for Pomalyst (4mg) and the standard starting dose for Kyprolis 20mg/m2. This gets bumped to 27 for following cycles if it's tolerated well. It changes only if a weight change of 20% or more occurs.
I'm thinking that, in the case of these newer drugs, sticking with the tested doses might be a good thing. However, I'd love for them to be able to individualize things more, not just drug dosages.
For example, the plasmacytomas that I had post transplant were noticeable to me in December. I started chemo day 90. The bumps went away for cycle one, but returned in cycle 2. I should have demanded a drug change, but instead I went along with the protocol that said lower the dosage and get Velcade once every other week instead of twice a week because my blood tests were good.
But, if bumps are growing on my skull, why should I try a maintenance dose at that point? But that's what protocol said. Blood numbers good ... proceed to maintenance.
There are so many variables with this disease. It's hard to know what to do. The experts seem confused.
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Joy - Name: Joy
- Who do you know with myeloma?: myself
- When were you/they diagnosed?: May 2013
- Age at diagnosis: 52
Re: Custom tailored dosing
I think any good doctor takes his own patients' circumstances into consideration when prescribing any treatment. But all varieties of medications come with dosing guidelines dependent upon the illness or disease they are treating.
There are so many variables to try to figure out how to dose someone specific to their own disease burden. I feel like it would take an awful lot of work and calculating to look at someone and say, they have this M spike, and these complicating factors, so I'll give them this much Velcade or whatever.
In addition to that, you have the whole manufacturing process to consider. In order to keep costs down, drugs need to made into certain doses for general use. Antibiotics are a good example of that. The same has to be true of myeloma drugs, or the already high cost could be much worse.
But I do believe looking at each patient individually and choosing to combine these two or three drugs, or leaving out a specific drug, is individualizing as much as possible.
There are so many variables to try to figure out how to dose someone specific to their own disease burden. I feel like it would take an awful lot of work and calculating to look at someone and say, they have this M spike, and these complicating factors, so I'll give them this much Velcade or whatever.
In addition to that, you have the whole manufacturing process to consider. In order to keep costs down, drugs need to made into certain doses for general use. Antibiotics are a good example of that. The same has to be true of myeloma drugs, or the already high cost could be much worse.
But I do believe looking at each patient individually and choosing to combine these two or three drugs, or leaving out a specific drug, is individualizing as much as possible.
Re: Custom tailored dosing
In my experience over 18 years of on and off treatment, I have been given the recommended dose. Particularly now that I am on a clinical trial of pomalidomide [Pomalyst] and dexamethasone. Wanting a rest from dex, I asked my doctor if the dose could be at least reduced. The answer was "No, but maybe down the track a bit we can put a case to the manufacturer of pomalidomide for a dose reduction. But we have to have a very good reason."
I have just started the 5th month of the trial, so am hopeful that in, say, a couple of months the dex can be reduced as the years of taking this awful drug seem to be catching up with me - especially with my skin going from severe dryness to out and out falling off my hands!
This time I have been on dex since February of last year with only a short break from October to December 2013.
I have just started the 5th month of the trial, so am hopeful that in, say, a couple of months the dex can be reduced as the years of taking this awful drug seem to be catching up with me - especially with my skin going from severe dryness to out and out falling off my hands!
This time I have been on dex since February of last year with only a short break from October to December 2013.
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SusanMary - Name: Susan Brown
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Feb 1996
- Age at diagnosis: 47
Re: Custom tailored dosing
SusanMary,
You bring up a point I never considered. Does a doctor have to get permission from a drug company to use a "non-standard" dose and/or use a drug off-label? I've always assumed that a doctor has complete discretion in both of these matters.
You bring up a point I never considered. Does a doctor have to get permission from a drug company to use a "non-standard" dose and/or use a drug off-label? I've always assumed that a doctor has complete discretion in both of these matters.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Custom tailored dosing
In a clinical trial like the one in which SusanMary is participating, drug dosing typically is tightly controlled. There are often usually protocols specifying when a patient can be moved from one dose to another. This is to ensure that the results of the trial can be tied to a specific way of using the drug, rather than doctor or patient preference, and also to ensure that the trial results can be tested in other trials, or easily compared to the results of other trials.
Outside of a clinical trial, dosing is much more up to the doctor and patient, as long as the dose is at or below the officially approved dose. If the dose is going to be higher than the approved dose, there will probably be some issues with insurance / health system reimbursement. However, as best we can tell, going higher than the recommended dose is not an option that doctors recommend very often.
Outside of a clinical trial, dosing is much more up to the doctor and patient, as long as the dose is at or below the officially approved dose. If the dose is going to be higher than the approved dose, there will probably be some issues with insurance / health system reimbursement. However, as best we can tell, going higher than the recommended dose is not an option that doctors recommend very often.
Re: Custom tailored dosing
The Beacon brings up a very important point about clinical trials and drug dosages. By the time a trial is in Phase II trial the dosage for a drug has pretty much been determined and is tested on a wider group of people. When the drug is submitted for approval to the FDA, it is submitted at a particular dosage level with the research to back up its efficacy at that level. If approved by the FDA it is approved at this dosage level. For insurance to cover the cost of a new drug, doctors are pretty much required to prescribe it at that approved dose and protocol. With further research and experience with the drug, then alterations to the dose and timing gradually begin to be used.
I know that my oncologist wanted to start me on Revlimid for induction, but he asked me what my insurance coverage was for prescriptions before he finally decided on it. I appreciated the fact that he had expense in mind, since he felt either Revlimid or Velcade would be appropriate for my induction therapy.
Since I was was working full time he was leaning more towards Revlimid, because it would cause less of an interruption to my work life. Velcade at the time was only given as an infusion 2 times per week. I started my induction therapy with Revlimid at 15 mg per day for 21 days on and 7 days off. Another person who started treatment at the same time as me with the same doctor started induction with 25 mg. Why did I get 15 mg and the other person 25 mg? I assume that it was because of how the myeloma was affecting each of us.
In the 5 years since I started treatment there have been many changes in how the different oncologists decide on treatment. Some stick to a protocol that is pretty much the same for every patient. Some decide on treatment strategies based on genetic make-up and risk level. Some use their experience with the different drugs and various patient responses to treatment to decide on what to prescribe.
There are so many different factors that come into play in picking a treatment strategy. At this point, there really isn't a treatment designed for a specific treatment based on the individual's cancer cell characteristics, but that is something that may be in the future for multiple myeloma treatment.
Having an oncologist who you trust, who keeps up to date with the latest research, who listens to what you have to say about side effects and what you want, and who doesn't just prescribe by protocol is important. Having all of that is the closest you will get to designer treatment at this point.
I know that my oncologist wanted to start me on Revlimid for induction, but he asked me what my insurance coverage was for prescriptions before he finally decided on it. I appreciated the fact that he had expense in mind, since he felt either Revlimid or Velcade would be appropriate for my induction therapy.
Since I was was working full time he was leaning more towards Revlimid, because it would cause less of an interruption to my work life. Velcade at the time was only given as an infusion 2 times per week. I started my induction therapy with Revlimid at 15 mg per day for 21 days on and 7 days off. Another person who started treatment at the same time as me with the same doctor started induction with 25 mg. Why did I get 15 mg and the other person 25 mg? I assume that it was because of how the myeloma was affecting each of us.
In the 5 years since I started treatment there have been many changes in how the different oncologists decide on treatment. Some stick to a protocol that is pretty much the same for every patient. Some decide on treatment strategies based on genetic make-up and risk level. Some use their experience with the different drugs and various patient responses to treatment to decide on what to prescribe.
There are so many different factors that come into play in picking a treatment strategy. At this point, there really isn't a treatment designed for a specific treatment based on the individual's cancer cell characteristics, but that is something that may be in the future for multiple myeloma treatment.
Having an oncologist who you trust, who keeps up to date with the latest research, who listens to what you have to say about side effects and what you want, and who doesn't just prescribe by protocol is important. Having all of that is the closest you will get to designer treatment at this point.
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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
Re: Custom tailored dosing
Beacon Staff wrote:In a clinical trial like the one in which SusanMary is participating, drug dosing typically is tightly controlled. There are often usually protocols specifying when a patient can be moved from one dose to another. This is to ensure that the results of the trial can be tied to a specific way of using the drug, rather than doctor or patient preference, and also to ensure that the trial results can be tested in other trials, or easily compared to the results of other trials.
Outside of a clinical trial, dosing is much more up to the doctor and patient, as long as the dose is at or below the officially approved dose. If the dose is going to be higher than the approved dose, there will probably be some issues with insurance / health system reimbursement. However, as best we can tell, going higher than the recommended dose is not an option that doctors recommend very often.
Due to the fact that I have not looked at the forum for a short while, I have not answered the question asked by Multibilly; I apologise for this. The answer given above is just what I would have said and how I understand things to be. So thank you "Beacon Staff" for stepping in and answering this question.
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SusanMary - Name: Susan Brown
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Feb 1996
- Age at diagnosis: 47
Re: Custom tailored dosing
My bad not picking up on the trial aspect of SusanMary's post. I totally get the need for standardized dosing in a trial setting. I was thinking more along the lines of custom dosing outside of a trial setting. I appreciate all the replies.
One thing I've also pondered is how it took so long to recognize that lower dose dex can work just effectively (if not better) than high dose dex with IMIDs. Did the original RD and VRD trials not tweak the dex dose (just assuming that higher dose dex was more efficacious), or did they only tweak the Revlimid and Velcade doses in the original trial arms?
As I recall, I believe they just recently found that lower dose Pomalyst also works just as well as the original, recommended higher dose Pomalyst if you just tweak the administration cycle.
I for one like the idea of a doctor having the freedom to adjust to lower doses (or higher, I suppose) based on a patient's unique circumstances. I was also amazed to hear the other day that doctors outside of the USA don't typically have this kind of latitude and must instead adhere to whatever the country's medical system and/or drug company dictates ;-(
Anyway, just more good reasons to be working with a top specialist.
One thing I've also pondered is how it took so long to recognize that lower dose dex can work just effectively (if not better) than high dose dex with IMIDs. Did the original RD and VRD trials not tweak the dex dose (just assuming that higher dose dex was more efficacious), or did they only tweak the Revlimid and Velcade doses in the original trial arms?
As I recall, I believe they just recently found that lower dose Pomalyst also works just as well as the original, recommended higher dose Pomalyst if you just tweak the administration cycle.
I for one like the idea of a doctor having the freedom to adjust to lower doses (or higher, I suppose) based on a patient's unique circumstances. I was also amazed to hear the other day that doctors outside of the USA don't typically have this kind of latitude and must instead adhere to whatever the country's medical system and/or drug company dictates ;-(
Anyway, just more good reasons to be working with a top specialist.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Custom tailored dosing
Hi Multibilly ... I may have left the wrong impression about 'latitude' for oncologists in my country. I don't think that 'dosing' for an approved drug is an issue.
For example, for any drug that is infused, the dosing depends on the 'metre squared' of the patient. Examples of drugs used in this way are melphalan and Velcade. I don't understand why that measurement is used, instead of, for example, one's weight in kg. or lb., but it is 'tailoring' for a drug.
Also, for a drug taken in pill form, there are different dosages. For example, Revlimid comes in doses from 2.5 mg to 25 mg, as far as I know. Different patients can tolerate different doses, or the drug may be used in different situations at different doses.
But the point you make about drugs not being allowed to be used 'off label' is a good one! We are in different types of health care systems.
For example, for any drug that is infused, the dosing depends on the 'metre squared' of the patient. Examples of drugs used in this way are melphalan and Velcade. I don't understand why that measurement is used, instead of, for example, one's weight in kg. or lb., but it is 'tailoring' for a drug.
Also, for a drug taken in pill form, there are different dosages. For example, Revlimid comes in doses from 2.5 mg to 25 mg, as far as I know. Different patients can tolerate different doses, or the drug may be used in different situations at different doses.
But the point you make about drugs not being allowed to be used 'off label' is a good one! We are in different types of health care systems.
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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
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