I've been living with low level relapse for a while, but my M-spike is creeping a bit higher and treatment is in my future. I did my initial induction – Velcade, high dose dex, and cyclophosphamide, plus transplant – in 2010.
The plan was for me to do Revlimid and dex, since I have not had Revlimid or thalidomide yet, and maybe Velcade again, then a second auto stem cell transplant (SCT).
But, there is a drug trial at my hospital with daratumumab. Of course, it is a blind Phase 3 trial, and I may be assigned to the placebo arm. No transplant is allowed in the trial, but I could do it at relapse from the trial.
Thoughts?
For the record, I am 37 years old and in good shape. If you looked at me, you would not tell I am living with cancer. I also just had a baby. He is healthy and thriving.
Forums
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
Hi lys2012,
I am going to guess that the trial is daratumumab plus something like Velcade & dex (Vd)? And that the placebo arm is simply Vd without daratumumab?
Assuming the placebo arm is Vd, what would your doc say about going on a Vd regimen since you already did VCD? If you want to do a trial, it would be nice to find a trial whose placebo arm lined up well with any currently available drug cocktails that you would consider independently of a trial.
Did they tell you when you would know whether you are on the placebo arm or not?
I am going to guess that the trial is daratumumab plus something like Velcade & dex (Vd)? And that the placebo arm is simply Vd without daratumumab?
Assuming the placebo arm is Vd, what would your doc say about going on a Vd regimen since you already did VCD? If you want to do a trial, it would be nice to find a trial whose placebo arm lined up well with any currently available drug cocktails that you would consider independently of a trial.
Did they tell you when you would know whether you are on the placebo arm or not?
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
Congratulations on your baby boy. You must be delighted.
There was recently a media release about the success that the daratumumab is having in clinical trials in Melbourne's St. Vincents Hospital. I don't know how you would get the official version. However, the media release said something about out of 15 patience a third reached complete response between 8 - 12 weeks.
Not sure what happened with the other 10. I think their levels were reduced.
Good luck.
There was recently a media release about the success that the daratumumab is having in clinical trials in Melbourne's St. Vincents Hospital. I don't know how you would get the official version. However, the media release said something about out of 15 patience a third reached complete response between 8 - 12 weeks.
Not sure what happened with the other 10. I think their levels were reduced.
Good luck.
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vicstir - Name: Vic
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: October 2013
- Age at diagnosis: 39
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
Sorry I should be more clear.
The trial is: Revlimid + dex + daratumumab versus Revlimid + dex + placebo. I don't know if you are told if you have the active drug or not?
I have not taken Revlimid yet, so my plan for relapse was supposed to be Revlimid + dex (maybe repeat Velcade), then a second transplant.
I just saw this trial posted when I was looking up on my hospital website. I see my doctor next month for my two month check in, so I am trying to think about my next steps ahead of time! And see if I should try and get into the trial. It is for relapsed multiple myeloma patients who have not taken Revlimid in prior therapy.
The trial is: Revlimid + dex + daratumumab versus Revlimid + dex + placebo. I don't know if you are told if you have the active drug or not?
I have not taken Revlimid yet, so my plan for relapse was supposed to be Revlimid + dex (maybe repeat Velcade), then a second transplant.
I just saw this trial posted when I was looking up on my hospital website. I see my doctor next month for my two month check in, so I am trying to think about my next steps ahead of time! And see if I should try and get into the trial. It is for relapsed multiple myeloma patients who have not taken Revlimid in prior therapy.
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lys2012 - Name: Alyssa
- When were you/they diagnosed?: 2010, Toronto, Canada
- Age at diagnosis: 32
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
I wasn't aware of any open trials with daratumumab + Revlimid for previously treated multiple myeloma patients. Are you outside of the USA?
Keeping in mind that I haven't been on any multiple myeloma drugs yet myself, the placebo arm strikes me as not all that bad since it uses one of the cocktails you were considering anyway.
In any case, I would inquire about their various policies for placebo patients throughout the trial. This link may give you some ideas of things you may want to ask about:
http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/placebos-cancer-clinical-trials
.
Keeping in mind that I haven't been on any multiple myeloma drugs yet myself, the placebo arm strikes me as not all that bad since it uses one of the cocktails you were considering anyway.
In any case, I would inquire about their various policies for placebo patients throughout the trial. This link may give you some ideas of things you may want to ask about:
http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/placebos-cancer-clinical-trials
.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
You are correct, I am not in the U.S.A., but in Canada. 
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lys2012 - Name: Alyssa
- When were you/they diagnosed?: 2010, Toronto, Canada
- Age at diagnosis: 32
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
Congratulations Lys on having your baby! That is wonderful news!
I looked at Clinicaltrials.gov to try to find the clinical trial you mentioned but I could not find it either. Perhaps it is already 'active, but not recruiting'. If your doctor gets patients into clinical trials for myeloma, he/she may know about that.
Daratumumab is a monoclonal antibody type of treatment, and none of those are yet approved in Canada, or on 'special access', as daratumumab is now going to be in the US. I think that clinical trials are the main way in which a patient could try them here. It seemed like the trial you found would be a good fit for your situation though. All the best ... enjoy your little one!
I looked at Clinicaltrials.gov to try to find the clinical trial you mentioned but I could not find it either. Perhaps it is already 'active, but not recruiting'. If your doctor gets patients into clinical trials for myeloma, he/she may know about that.
Daratumumab is a monoclonal antibody type of treatment, and none of those are yet approved in Canada, or on 'special access', as daratumumab is now going to be in the US. I think that clinical trials are the main way in which a patient could try them here. It seemed like the trial you found would be a good fit for your situation though. All the best ... enjoy your little one!
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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: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
lys,
I'm in a daratumumab trial, and on my treatment day yesterday my oncologist mentioned that Janssen recently opened an "expanded access program" for myeloma patients who are "double refractory". The daratumumab will be available at 40 centers, and I highly recommend you check out the following link:
http://www.prnewswire.com/news-releases/daratumumab-expanded-access-program-open-to-eligible-us-patients-with-heavily-pre-treated-multiple-myeloma-300108477.html
The expanded access program is not a trial, so if you're eligible, you would get dara without the possibility of getting a placebo. And I'm pretty sure Janssen provides the drug free, just as in a trial. (I'm not certain you are "double refractory, but it sounds like you are.)
I had an M-spike of 1.6 when I started on heavy dose dara in Oct 2013; now, I've had an M-spike of 0.0 and normal light chains since April 2014. The side effects have been almost zilch for me; about all I get is a flushed face for a couple of days, which is probably less than the hot flashes normal people experience.
Best wishes and God bless.
banrelk4
I'm in a daratumumab trial, and on my treatment day yesterday my oncologist mentioned that Janssen recently opened an "expanded access program" for myeloma patients who are "double refractory". The daratumumab will be available at 40 centers, and I highly recommend you check out the following link:
http://www.prnewswire.com/news-releases/daratumumab-expanded-access-program-open-to-eligible-us-patients-with-heavily-pre-treated-multiple-myeloma-300108477.html
The expanded access program is not a trial, so if you're eligible, you would get dara without the possibility of getting a placebo. And I'm pretty sure Janssen provides the drug free, just as in a trial. (I'm not certain you are "double refractory, but it sounds like you are.)
I had an M-spike of 1.6 when I started on heavy dose dara in Oct 2013; now, I've had an M-spike of 0.0 and normal light chains since April 2014. The side effects have been almost zilch for me; about all I get is a flushed face for a couple of days, which is probably less than the hot flashes normal people experience.
Best wishes and God bless.
banrelk4
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Banrelk4 - Name: E.C.
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Oct 2010
- Age at diagnosis: 73
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
Cheers E.C.,
It's great that you've responded so well to daratumumab. The drug seems to be very promising, and I hope it is approved and reimbursed soon in many countries around the world.
Unfortunately, the daratumumab expanded access programme is only for myeloma patients in the States, and Lys2012 lives in Canada, as she mentioned in the discussion thread above. Also, the programme is in fact a clinical trial, although you are correct that it's not a randomised clinical trial where some patients would get a placebo instead of daratumumab. Finally, daratumumab is provided at no cost to patients who participate in the programme.
One other thing about the programme that is important is that, to participate, a patient must have had at least three previous lines of therapy, including at least one proteasome inhibitor (Velcade, carfilzomib [Kyprolis], etc.) and one immunomodulatory agent (thalidomide, Revlimid, or pomalidomide [Pomalyst, Imnovid]). Lys has not yet been treated with an immunomodulatory agent, and I don't think she would be considered to have had three lines of therapy.
The daratumumab programme is described in a lot of detail in a Beacon article last month,
"Daratumumab Expanded Access Program Initiated" (July 7, 2015)
Lys - Given what you've had for treatments so far, I think the trial you mentioned would make a lot of sense for you. You were considering going on Revlimid and dex anyway, and you would get those for certain in the trial. The only unknown would be whether or not you get daratumumab.
It probably will be a while before daratumumab is approved and reimbursed in Canada, so this would be a way to possibly get access to the drug now. The one thing you might give up by participating in the trial is having a second transplant immediately after the drug treatment, but that doesn't mean you could not ever have a second transplant. It would just be delayed until after your next treatment after the one you're currently planning.
It's great that you've responded so well to daratumumab. The drug seems to be very promising, and I hope it is approved and reimbursed soon in many countries around the world.
Unfortunately, the daratumumab expanded access programme is only for myeloma patients in the States, and Lys2012 lives in Canada, as she mentioned in the discussion thread above. Also, the programme is in fact a clinical trial, although you are correct that it's not a randomised clinical trial where some patients would get a placebo instead of daratumumab. Finally, daratumumab is provided at no cost to patients who participate in the programme.
One other thing about the programme that is important is that, to participate, a patient must have had at least three previous lines of therapy, including at least one proteasome inhibitor (Velcade, carfilzomib [Kyprolis], etc.) and one immunomodulatory agent (thalidomide, Revlimid, or pomalidomide [Pomalyst, Imnovid]). Lys has not yet been treated with an immunomodulatory agent, and I don't think she would be considered to have had three lines of therapy.
The daratumumab programme is described in a lot of detail in a Beacon article last month,
"Daratumumab Expanded Access Program Initiated" (July 7, 2015)
Lys - Given what you've had for treatments so far, I think the trial you mentioned would make a lot of sense for you. You were considering going on Revlimid and dex anyway, and you would get those for certain in the trial. The only unknown would be whether or not you get daratumumab.
It probably will be a while before daratumumab is approved and reimbursed in Canada, so this would be a way to possibly get access to the drug now. The one thing you might give up by participating in the trial is having a second transplant immediately after the drug treatment, but that doesn't mean you could not ever have a second transplant. It would just be delayed until after your next treatment after the one you're currently planning.
Re: RVD + SCT, or trial of Revlimid, dex, and daratumumab?
Hi Lys
We have only been on the multiple myeloma journey for 14 months. My husband is IgA lambda and appears to have an uncommon and aggressive myeloma. As a consequence, he was on the panobinostat (Farydak) trial (histone deacetylase inhibitor) for 7 months until he experienced disease progression. On Sunday, he goes in for his stem cell transplant plus a trial using natural killer cells.
My point in sharing this information with you is that we have decided to try all options given his type of myeloma. I even asked our oncologist if elotuzumab (Empliciti) might be an option for his maintenance chemotherapy following the stem cell transplant. Like daratumumab, elotuzumab is a monoclonal antibody. The results of the Eloquent-2 trial – elotuzumab along with Revlimid and dexamethasone – were quite positive.
Entering a clinical trial is always a personal choice for a patient. If you are in relatively good shape, entering a trial using daratumumab might be a viable option for you. As you mentioned, though, you might end up in the placebo group. Since multiple myeloma is not curable, our only hope comes from trials and individuals willing to participate. Whatever your decision, we wish you the best of luck.
We have only been on the multiple myeloma journey for 14 months. My husband is IgA lambda and appears to have an uncommon and aggressive myeloma. As a consequence, he was on the panobinostat (Farydak) trial (histone deacetylase inhibitor) for 7 months until he experienced disease progression. On Sunday, he goes in for his stem cell transplant plus a trial using natural killer cells.
My point in sharing this information with you is that we have decided to try all options given his type of myeloma. I even asked our oncologist if elotuzumab (Empliciti) might be an option for his maintenance chemotherapy following the stem cell transplant. Like daratumumab, elotuzumab is a monoclonal antibody. The results of the Eloquent-2 trial – elotuzumab along with Revlimid and dexamethasone – were quite positive.
Entering a clinical trial is always a personal choice for a patient. If you are in relatively good shape, entering a trial using daratumumab might be a viable option for you. As you mentioned, though, you might end up in the placebo group. Since multiple myeloma is not curable, our only hope comes from trials and individuals willing to participate. Whatever your decision, we wish you the best of luck.
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PattyB - Name: PattyB
- Who do you know with myeloma?: husband
- When were you/they diagnosed?: July 2014
- Age at diagnosis: 64
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