Hi,
I was diagnosed with smoldering multiple myeloma a couple of years ago and have been asked to participate in a study for Darzalex (daratumumab), and I am not sure if I would like to participate in this study.
Any input would be greatly appreciated. Thank you.
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• Page 1 of 1
Re: Darzalex clinical trial for smoldering myeloma
Hi Annie:
There is a lot to consider on entering a clinical trial. You have to be able to convince yourself that you are a "match" overall. That, for example, you are not forgoing any other treatments or approaches that would be better for you.
Darzalex is very active, and it is not thought to have long-term toxicities. It takes a long time to infuse, and many people have some degree of short-term side effects, most of which are reported to be not that bad. I have heard some doctors state that the side effects are like for the flu shots or other vaccines.
Because of the side effect profile, the idea is that it could knock down the level of myeloma, and delay its onset, at low risk. So if I were you, I would study it thoroughly and look at it as a potential opportunity.
Good luck.
There is a lot to consider on entering a clinical trial. You have to be able to convince yourself that you are a "match" overall. That, for example, you are not forgoing any other treatments or approaches that would be better for you.
Darzalex is very active, and it is not thought to have long-term toxicities. It takes a long time to infuse, and many people have some degree of short-term side effects, most of which are reported to be not that bad. I have heard some doctors state that the side effects are like for the flu shots or other vaccines.
Because of the side effect profile, the idea is that it could knock down the level of myeloma, and delay its onset, at low risk. So if I were you, I would study it thoroughly and look at it as a potential opportunity.
Good luck.
-
JPC - Name: JPC
Re: Darzalex clinical trial for smoldering myeloma
Hi Annie,
I believe that this trial is for high-risk smoldering myeloma. If your doctor is asking you to consider it, then you must be high risk. Being high risk means that your chances of converting to full blown myeloma are high.
I have been waiting for this trial to start recruiting in my area since early December and pray that, when it does, I am still smoldering. For me, the chance to possibly delay the necessity for the current front line treatments and all the side effects they may bring is important.
Everything I have read about Darzalex indicates that the side effects are primarily infusion-related and usually only for the first one or two infusions. I am not trying to influence your decision, but you asked for input.
I wish you the best whichever way you decide and ask that if you do decide to enter the trial, that you keep us posted on your progress.
Good Luck
Peter
I believe that this trial is for high-risk smoldering myeloma. If your doctor is asking you to consider it, then you must be high risk. Being high risk means that your chances of converting to full blown myeloma are high.
I have been waiting for this trial to start recruiting in my area since early December and pray that, when it does, I am still smoldering. For me, the chance to possibly delay the necessity for the current front line treatments and all the side effects they may bring is important.
Everything I have read about Darzalex indicates that the side effects are primarily infusion-related and usually only for the first one or two infusions. I am not trying to influence your decision, but you asked for input.
I wish you the best whichever way you decide and ask that if you do decide to enter the trial, that you keep us posted on your progress.
Good Luck
Peter
Re: Darzalex clinical trial for smoldering myeloma
Hi Annie,
Both of the previous commenters have given you some good information. I'm going to come at your question from a different perspective - I have been a clinical trial participant for over three years now.
When I began my myeloma treatment, I started in the trial and its protocol has guided my treatment through induction, stem cell transplant, consolidation, and now maintenance.
I had two motivations for participating in the trial. First, I wanted to help move the science behind myeloma treatment forward in my own little way. Second, I wanted to have state-of-the art treatment.
I'm very glad that I've been in the trial. I think both of my motivations have been met. Of course, what was state-of-the-art three years ago is not so leading edge now, but that's a good thing for us patients. It's a sign of progress.
One additional benefit that I had not thought of when I enrolled is that I am more closely monitored than a patient would normally be at my stage of treatment. I see my doctor and get blood work every month now, when it would be once every three months if I weren't on trial. On one hand, it's more travel in to see the doctor and more of a time commitment. But I feel reassured by the closer monitoring.
As in any clinical trial, you'll have the option to drop out of the trial at any time, for any reason. And your doctor may remove you from the trial if s/he thinks it is your best interest to have treatment that is off protocol.
In the trial that I'm on, there is fairly wide latitude regarding some of the treatment. For example, in the maintenance phase, I've received between 5 mg of Revlimid 21 out of 28 days and 15 mg everyday depending on the side effects I'm experiencing.
One piece of advice is to read the informed consent document very carefully. If you have any concerns about anything in the document, discuss those concerns with your doctor.
Best wishes to you. Please let us know which decision you make. There really is no wrong decision here. What matters most is what you're comfortable doing, as JPC said.
Mike
Both of the previous commenters have given you some good information. I'm going to come at your question from a different perspective - I have been a clinical trial participant for over three years now.
When I began my myeloma treatment, I started in the trial and its protocol has guided my treatment through induction, stem cell transplant, consolidation, and now maintenance.
I had two motivations for participating in the trial. First, I wanted to help move the science behind myeloma treatment forward in my own little way. Second, I wanted to have state-of-the art treatment.
I'm very glad that I've been in the trial. I think both of my motivations have been met. Of course, what was state-of-the-art three years ago is not so leading edge now, but that's a good thing for us patients. It's a sign of progress.
One additional benefit that I had not thought of when I enrolled is that I am more closely monitored than a patient would normally be at my stage of treatment. I see my doctor and get blood work every month now, when it would be once every three months if I weren't on trial. On one hand, it's more travel in to see the doctor and more of a time commitment. But I feel reassured by the closer monitoring.
As in any clinical trial, you'll have the option to drop out of the trial at any time, for any reason. And your doctor may remove you from the trial if s/he thinks it is your best interest to have treatment that is off protocol.
In the trial that I'm on, there is fairly wide latitude regarding some of the treatment. For example, in the maintenance phase, I've received between 5 mg of Revlimid 21 out of 28 days and 15 mg everyday depending on the side effects I'm experiencing.
One piece of advice is to read the informed consent document very carefully. If you have any concerns about anything in the document, discuss those concerns with your doctor.
Best wishes to you. Please let us know which decision you make. There really is no wrong decision here. What matters most is what you're comfortable doing, as JPC said.
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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