I selected to be in a clinical trial of Revlimid, Velcade, dexamethasone (RVD) and was randomized to Arm A - Harvest Only (March 2016). I am Stage 3 myeloma and have been on the trial with a partial response and typical side effects. My pain remains in my back, and I am using a walker. I have a visible curve in my spine with fractures and collapsed discs from T - L/4-L5. I asked if I could finish the trial (August 2016) and then have a full stem cell transplant (auto). I will meet with the transplant team in 2 weeks to discuss this further.
The oncologist replied that they want my M-spike to be lower (currently 0.8 g/dL, ideally needs to be less than 0.5) before proceeding. So I might need additional cycles of RVD before transplant is performed.
The trial coordinator replied: For study purposes, I will stay on study treatment until disease progression, after which we will just do long-term follow up to monitor myeloma status and other treatments, generally via medical records. A transplant now or in November/December without disease progression would still mean I would need to come off the study at that time.
Do I understand this to mean I need progression or relapse to quality me for a transplant?
I want the best possible outcome. I have read transplant before relapse offers a better percentage of success for remission. I don't want to leave any stone unturned. I have been through so much (2 years of pain before diagnosis) not to take this deep dive while I am still willing to go for it. At this time I do not see myself returning to my full-time work soon. My fatigue is unreal, my pain and my ability to see/focus and 'act normal' have changed.
I guess what I am stating - let me out of the trial in August - let me have the transplant and then if that does not prove well - put me on the next drug of the day. Revlimid is not the best drug of my choice and has caused me so many unwanted side effects.
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Marysage - Name: Mary S
- Who do you know with myeloma?: Self
- When were you/they diagnosed?: 11/15
- Age at diagnosis: 56
Re: Should I drop out of the clinical trial I'm in?
Hello Mary:
Having looked and being in one small clinical trial in my wife's case, I do understand that in theory that in the US that you should be able to drop out of the clinical trial at any time, simply without any reason (let's just say you were simply just not comfortable) without any repercussions. As a practical matter, if the trial is local in your center, then there is someone on that team who will probably urge you to stay on trial. There is in my view typically a level of pressure.
I would clearly tell the staff that you no longer think this trial is working for you (if that is the way you feel). Those are the rules in the U.S.; however, if you are elsewhere, I am guessing it should be the same, but am not 100% sure.
Having looked and being in one small clinical trial in my wife's case, I do understand that in theory that in the US that you should be able to drop out of the clinical trial at any time, simply without any reason (let's just say you were simply just not comfortable) without any repercussions. As a practical matter, if the trial is local in your center, then there is someone on that team who will probably urge you to stay on trial. There is in my view typically a level of pressure.
I would clearly tell the staff that you no longer think this trial is working for you (if that is the way you feel). Those are the rules in the U.S.; however, if you are elsewhere, I am guessing it should be the same, but am not 100% sure.
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JPC - Name: JPC
Re: Should I drop out of the clinical trial I'm in?
As far as I know, one can drop out of a trial at any time. JPC does raise an important point about whether the trial is one that is being run in the center where you are normally treated, or not. But, if you feel that the treatment you are getting isn't giving you the best response, you are having side effects that limit your quality of life, etc, then you should be able to drop out of the trial and pursue another line of treatment with a transplant as part of it.
My question is: What is being done about the fractures in your spine? Is anyone paying attention to those? Or, are they so focused on the trial that your other problems are being neglected? You probably would feel a whole lot better if the pain from your spine was adequately addressed.
Nancy in Phila
My question is: What is being done about the fractures in your spine? Is anyone paying attention to those? Or, are they so focused on the trial that your other problems are being neglected? You probably would feel a whole lot better if the pain from your spine was adequately addressed.
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
Re: Should I drop out of the clinical trial I'm in?
Hi Marysage,
I'm so sorry you are in so much pain. I agree with Nancy - you should get those fractures taken care of immediately!
You mention that you were Stage III when you were diagnosed, so I'm assuming you had a very high M-spike. But now your M-spike is at 0.8 g/dl. It may be a partial response, but given where you started from, that seems like it would be a huge improvement! I wouldn't be discouraged. How long have you been in the trial? You mention that the study completes in August of this year. That means you expect to have at least five more cycles, so there may still be room for improvement.
Many multiple myeloma patients and doctors today are questioning whether stem cell transplants are even necessary with the newer multiple myeloma drugs, like Revlimid and Velcade. If you search the forums, you'll find several lively discussions about the necessity of stem cell transplants, especially if you've had RVD as your induction therapy.
If you are having bad side effects from the RVD, ask your doctor or the study team if there is an option for lowering the doses. I know Revlimid is available in several different doses, but I'm not sure about the Velcade.
I'm a little confused because you say that you will stay on the study treatment until disease progression. You mean even after the study is over in August you are still going to be on RVD? You may want to talk to the doctors about this. Again, if possible, could you do a lower dose of Revlimid for your maintenance, and drop the Velcade altogether.
Just some thoughts. Good luck.
Lyn
I'm so sorry you are in so much pain. I agree with Nancy - you should get those fractures taken care of immediately!
You mention that you were Stage III when you were diagnosed, so I'm assuming you had a very high M-spike. But now your M-spike is at 0.8 g/dl. It may be a partial response, but given where you started from, that seems like it would be a huge improvement! I wouldn't be discouraged. How long have you been in the trial? You mention that the study completes in August of this year. That means you expect to have at least five more cycles, so there may still be room for improvement.
Many multiple myeloma patients and doctors today are questioning whether stem cell transplants are even necessary with the newer multiple myeloma drugs, like Revlimid and Velcade. If you search the forums, you'll find several lively discussions about the necessity of stem cell transplants, especially if you've had RVD as your induction therapy.
If you are having bad side effects from the RVD, ask your doctor or the study team if there is an option for lowering the doses. I know Revlimid is available in several different doses, but I'm not sure about the Velcade.
I'm a little confused because you say that you will stay on the study treatment until disease progression. You mean even after the study is over in August you are still going to be on RVD? You may want to talk to the doctors about this. Again, if possible, could you do a lower dose of Revlimid for your maintenance, and drop the Velcade altogether.
Just some thoughts. Good luck.
Lyn
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Christa's Mom - Name: Christa's Mom
- Who do you know with myeloma?: Husband
- When were you/they diagnosed?: September, 2010
- Age at diagnosis: 53
Re: Should I drop out of the clinical trial I'm in?
Hi Mary,
First of all, thanks for participating in a clinical trial and helping to move the science of treating multiple myeloma forward.
However, your first responsibility is to yourself, making sure that you get the best possible treatment for you. That also is your doctor's first responsibility. So talk with your doctor openly and honestly about what is working well and what is not working for you, as well as what options are available, both within and outside of the trial. Some trials are more flexible than you might expect.
I am in a clinical trial and have had my doctor take me off the trial when there were concerns about Revlimid affecting my heart. After we found that I could tolerate lowering the dose, I went back on the trial. At all times, I was sure that my doctor was putting my best interests ahead of the interests of the trial, as he should.
Best wishes to you. Please keep us posted on how things go for you.
Mike
First of all, thanks for participating in a clinical trial and helping to move the science of treating multiple myeloma forward.
However, your first responsibility is to yourself, making sure that you get the best possible treatment for you. That also is your doctor's first responsibility. So talk with your doctor openly and honestly about what is working well and what is not working for you, as well as what options are available, both within and outside of the trial. Some trials are more flexible than you might expect.
I am in a clinical trial and have had my doctor take me off the trial when there were concerns about Revlimid affecting my heart. After we found that I could tolerate lowering the dose, I went back on the trial. At all times, I was sure that my doctor was putting my best interests ahead of the interests of the trial, as he should.
Best wishes to you. Please keep us posted on how things go for you.
Mike
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mikeb - Name: mikeb
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 2009 (MGUS at that time)
- Age at diagnosis: 55
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