I have had SMM for a few years now (stable with no change) and am considering participating in a clinical trial that I believe consists of a month of a daily lenalidomide [Revlimid] dose followed by a single monthly dose for many months. No other drugs/treatment would be involved.
Due to quality of life issues (airline travel) I would like to know the probability that monthly lenalidomide dosage would have a negative effect on my immune system.
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chinook9 - Name: Brian
- Who do you know with myeloma?: Self
- When were you/they diagnosed?: MGUS 8/2008 SMM 6/2011
- Age at diagnosis: 65
Re: Effect of monthly Revlimid dosage on immune system?
Hi Brian, I could see two issues here. One would be a lowered immune system, but your blood would be tested monthly before you received your lenalidomide dose. If there were problems with low neutrophils and other white blood cells, you probably would have your dosage delayed.
Also, if you are flying, you might be advised to take a blood thinner such as low dose aspirin in order to avoid blood clots, or just to take it anyhow since the strong chemotherapy drugs sometimes cause clotting. Of course, i realize that many patients already take heparin or warfarin for that purpose, which are stronger drugs.
So this is not medical advice, but just based on my experience. I did take lenalidomide for a year, at a low dose. It helped me to get into my CR. Hope this helps.
Also, if you are flying, you might be advised to take a blood thinner such as low dose aspirin in order to avoid blood clots, or just to take it anyhow since the strong chemotherapy drugs sometimes cause clotting. Of course, i realize that many patients already take heparin or warfarin for that purpose, which are stronger drugs.
So this is not medical advice, but just based on my experience. I did take lenalidomide for a year, at a low dose. It helped me to get into my CR. Hope this 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: Effect of monthly Revlimid dosage on immune system?
Any therapy has the potential to effect your immune system, including Lenalidomide/Revilimid. Rev is a well tolerated therepy- a pill. However, it does have potential adverse effects. These primarily revolve around fatigue, myelosuppression, GI symptoms (constipation, diarrhea, colic), rash, muscle cramps, and in combination with dex increased risk for venus thrombotic events (clots in your veins). This being said it remains one of the best tolerated drugs that we have (for most individuals).
I am always in favor of a clinic trial. In this setting the trial is trying to determine if we treat patients with higher risk SMM (increased rate of transformation/progression to active disease) with a well tolerated drug (Revlimid), can we decrease progression to myeloma (increase PFS) and overall survival. I do not know the specifics of the trial or what the primary endpoint may be, but those are the questions I assume they are asking.
Generally, smoldering myeloma is observed, rather than treated (active surveillance). This is primarily because we have not had therapies like Revlimid that can be so well tolerated. The tolerance of Revlimid has led to studies like this. Some with success in terms of PFS and OS.
In Europe, the Spanish myeloma group presented data from a Phase 3 trial comparing Revlimid/dex vs nothing and demonstrated both a PFS and OS advantage in patients receiving Rev/dex (Meteos et al ASH 2011). These studies need longer term follow-up AND additional studies to confirm the results before we adopt this for practice in all higer risk SMM patients. However, it does provide important data suggesting changes in practice.
The specifics were discussed in a Beacon article after ASH 2011:
"Revlimid-Dexamethasone Combination Delays Disease Progression In Patients With Smoldering Multiple Myeloma (ASH 2011), Howard Chang and Maike Haehle; Jan 9, 2012.
All of this being said. I would recommend you consider the trial. If the treatment is too toxic 1) dose reductions will be allowed and 2) you may always excuse yourself from a trial at anytime.
In the end you have to balance what is most important to you. But remember it is because of clinical trials and patients (and caregivers) who participate in them that we continue to make advance in myeloma therapy.
I am always in favor of a clinic trial. In this setting the trial is trying to determine if we treat patients with higher risk SMM (increased rate of transformation/progression to active disease) with a well tolerated drug (Revlimid), can we decrease progression to myeloma (increase PFS) and overall survival. I do not know the specifics of the trial or what the primary endpoint may be, but those are the questions I assume they are asking.
Generally, smoldering myeloma is observed, rather than treated (active surveillance). This is primarily because we have not had therapies like Revlimid that can be so well tolerated. The tolerance of Revlimid has led to studies like this. Some with success in terms of PFS and OS.
In Europe, the Spanish myeloma group presented data from a Phase 3 trial comparing Revlimid/dex vs nothing and demonstrated both a PFS and OS advantage in patients receiving Rev/dex (Meteos et al ASH 2011). These studies need longer term follow-up AND additional studies to confirm the results before we adopt this for practice in all higer risk SMM patients. However, it does provide important data suggesting changes in practice.
The specifics were discussed in a Beacon article after ASH 2011:
"Revlimid-Dexamethasone Combination Delays Disease Progression In Patients With Smoldering Multiple Myeloma (ASH 2011), Howard Chang and Maike Haehle; Jan 9, 2012.
All of this being said. I would recommend you consider the trial. If the treatment is too toxic 1) dose reductions will be allowed and 2) you may always excuse yourself from a trial at anytime.
In the end you have to balance what is most important to you. But remember it is because of clinical trials and patients (and caregivers) who participate in them that we continue to make advance in myeloma therapy.
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Dr. Ken Shain - Name: Ken Shain, M.D., Ph.D.
Beacon Medical Advisor
Re: Effect of monthly Revlimid dosage on immune system?
Nancy & Dr. Shain:
Thank you for the replies. I will read the article on the Phase 3 Spanish study.
I have a call in to the Mayo Clinic in Scottsdale, AZ to get more information about the clinical trial. I expect that if I can start the clinical trial in AZ and continue when I return to Colorado (there is a participating clinic down the street) in the Spring I will go ahead and do it.
Thank you again for helping me and for providing the assistance you provide to other members of the forum.
Thank you for the replies. I will read the article on the Phase 3 Spanish study.
I have a call in to the Mayo Clinic in Scottsdale, AZ to get more information about the clinical trial. I expect that if I can start the clinical trial in AZ and continue when I return to Colorado (there is a participating clinic down the street) in the Spring I will go ahead and do it.
Thank you again for helping me and for providing the assistance you provide to other members of the forum.
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chinook9 - Name: Brian
- Who do you know with myeloma?: Self
- When were you/they diagnosed?: MGUS 8/2008 SMM 6/2011
- Age at diagnosis: 65
Re: Effect of monthly Revlimid dosage on immune system?
I spoke to the clinical trials coordinator at the Mayo Clinic in Scottsdale, AZ yesterday and I am applying for participation in the trial. I winter in AZ and summer in CO so it will have to work between two institutions but that may be OK..
If I am randomly selected to take the drug it will be (apparently) continuous cycles of Revlimid with 25mg dosage on days 1-21 then 7 days off and then just repeat the cycle. I expect that the dosage is reduced if required to reduce negative side effects.
If I am selected for the control group, I just continue doing what I'm doing (no therapy) and continue ongoing observations which I expect will the same labs as those taking the drugs.
Wish me luck on be chosen to take the Revlimid!
If I am randomly selected to take the drug it will be (apparently) continuous cycles of Revlimid with 25mg dosage on days 1-21 then 7 days off and then just repeat the cycle. I expect that the dosage is reduced if required to reduce negative side effects.
If I am selected for the control group, I just continue doing what I'm doing (no therapy) and continue ongoing observations which I expect will the same labs as those taking the drugs.
Wish me luck on be chosen to take the Revlimid!
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chinook9 - Name: Brian
- Who do you know with myeloma?: Self
- When were you/they diagnosed?: MGUS 8/2008 SMM 6/2011
- Age at diagnosis: 65
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