Hello everyone,
My mother has been offered the possibility to enroll in a trial consisting of Rd [Revlimid and dexamethasone] + daratumumab.
It is a randomized study where she will receive Rd with or without daratumumab (this is yet to be determined based on a random 50-50 pick).
In France she was offered the conventional treatment which is MPV [melphalan, prednisone, Velcade] (because we refused having a stem cell transplant). I was not too keen about MPV and so we were offered the possibility to try the Rd + daratumumab trial.
Seeing as in France our options are limited, I thought it would be a good chance to be able to start on Revlimid, which is the most common frontline treatment in the USA.
If daratumumab is added to it, then that could be a good thing and if not then at least we'd be on Rd which is easier to take and without the PN effects of Velcade.
Do you agree with my reasoning?
I was hoping some of you would kindly share your thoughts. Are we making the right decision?
Many thanks and wishing you all well.
Maro
Forums
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Maro - Who do you know with myeloma?: My mom
- When were you/they diagnosed?: March 2014
- Age at diagnosis: 63
Re: Starting treatment with trial Rd + Daratumumab
Maro,
Why were you unhappy with MVP, which is a treatment for those not undergoing ASCT which has been researched and found to have good responses?
Does you mother's initial diagnostic blood / urine/ bone/ cytogenetic profile show anything that makes you feel, aside from the possible PN from Velcade, this treatment is unsuitable? Velcade given subcutaneously tends not to give such bad PN.
No problem I see with going on a trial as this is often what patients are resorted to do, but it is your mother's decision after speaking with the doctors on the pros and cons of the choices she has available. It is important to look at the research and ask questions before making choices.
There is no right or wrong choice as outcomes cannot be predicted and these treatments affect each person differently in terms of side affects. Once a choice is made then one must live with it and not look back.
Good luck.
Edna
Why were you unhappy with MVP, which is a treatment for those not undergoing ASCT which has been researched and found to have good responses?
Does you mother's initial diagnostic blood / urine/ bone/ cytogenetic profile show anything that makes you feel, aside from the possible PN from Velcade, this treatment is unsuitable? Velcade given subcutaneously tends not to give such bad PN.
No problem I see with going on a trial as this is often what patients are resorted to do, but it is your mother's decision after speaking with the doctors on the pros and cons of the choices she has available. It is important to look at the research and ask questions before making choices.
There is no right or wrong choice as outcomes cannot be predicted and these treatments affect each person differently in terms of side affects. Once a choice is made then one must live with it and not look back.
Good luck.
Edna
Re: Starting treatment with trial Rd + Daratumumab
Thank you Edna for your response. I must admit your response puts me in doubt...
She has t(14;16) and 50% PC after BMB.
The way the appointment took place was pretty much unilateral. The doctor sort of encouraged us to give Rd + daratumumab a try. I even asked him "If this was your mother, would this be your treatment of choice" to which he pretty much replied yes.
I was not very keen about the MPV due to PN but we surely were not going to refuse it.
When the doctor suggested we give this Rd+dara a trial it seemed like a good idea because Revlimid is also proven to be very effective and very used in the USA (and it is much more convenient since taken orally). Moreover, daratumumab looks extremely promising for longer and deeper responses according to recent studies.
Also, it comforted us to know that it does not rule out the possibility to use MPV in case my mother is refractory or does not respond well or has bad reaction to Revlimid.
I must admit that my mother really counts on me to help her in her decisions because she gets so anxious and stressed that she sort of disconnects and leaves it to me. It is a very hard and delicate role for me and it can give a very guilty feeling in case a wrong decision is taken.
She basically just trusts the doctor and leaves it to me and hopes for the best.
Are we making a wrong decision?
She has t(14;16) and 50% PC after BMB.
The way the appointment took place was pretty much unilateral. The doctor sort of encouraged us to give Rd + daratumumab a try. I even asked him "If this was your mother, would this be your treatment of choice" to which he pretty much replied yes.
I was not very keen about the MPV due to PN but we surely were not going to refuse it.
When the doctor suggested we give this Rd+dara a trial it seemed like a good idea because Revlimid is also proven to be very effective and very used in the USA (and it is much more convenient since taken orally). Moreover, daratumumab looks extremely promising for longer and deeper responses according to recent studies.
Also, it comforted us to know that it does not rule out the possibility to use MPV in case my mother is refractory or does not respond well or has bad reaction to Revlimid.
I must admit that my mother really counts on me to help her in her decisions because she gets so anxious and stressed that she sort of disconnects and leaves it to me. It is a very hard and delicate role for me and it can give a very guilty feeling in case a wrong decision is taken.
She basically just trusts the doctor and leaves it to me and hopes for the best.
Are we making a wrong decision?
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Maro - Who do you know with myeloma?: My mom
- When were you/they diagnosed?: March 2014
- Age at diagnosis: 63
Re: Starting treatment with trial Rd + Daratumumab
Maro
Now it is clearer why Rd (with/ without daratumamab) is being suggested for your mother. She has high risk cytogenetics. The following are Mayo clinic guidelines on treatments which mightb help you:
http://www.msmart.org/about.html
It looks like your doctors are making the appropriate choice, except in a trial if she is in the non dara arm she will be on a two drug regime rather than the recommended 3 drug one. Discuss this with the doctor, as I assume Revlimid is only available through a trial for your mother.
Edna
Now it is clearer why Rd (with/ without daratumamab) is being suggested for your mother. She has high risk cytogenetics. The following are Mayo clinic guidelines on treatments which mightb help you:
http://www.msmart.org/about.html
It looks like your doctors are making the appropriate choice, except in a trial if she is in the non dara arm she will be on a two drug regime rather than the recommended 3 drug one. Discuss this with the doctor, as I assume Revlimid is only available through a trial for your mother.
Edna
Re: Starting treatment with trial Rd + Daratumumab
Edna
I am surprised to find out that t(14;16) is high risk .. There are so little studies that support this and all/most reports barely ever mention t(14;16).
I was under the impression that t(4;14) was in the high risk end along with del 17p
Does high risk mean worse prognostic? Should I insist on a triplet? would MPV be more appropriate as a triplet in our case?
I am surprised to find out that t(14;16) is high risk .. There are so little studies that support this and all/most reports barely ever mention t(14;16).
I was under the impression that t(4;14) was in the high risk end along with del 17p
Does high risk mean worse prognostic? Should I insist on a triplet? would MPV be more appropriate as a triplet in our case?
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Maro - Who do you know with myeloma?: My mom
- When were you/they diagnosed?: March 2014
- Age at diagnosis: 63
Re: Starting treatment with trial Rd + Daratumumab
Maro
I am not a doctor and these are questions you must direct at the clinician treating your mother.
I see that your mother was diagnosed in March 2014, has she had any previous treatment? ~If so what?
Please do not worry at this stage when you need to review options and information. Patients on this website cannot decide on treatment decisions, they can only guide the approach you might take to getting as much information as necessary to make an informed decision.
If you feel unhappy with the decisions of your doctor, whom I assume is a myeloma specialist, please seek a second opinion it might help. If you do not have the input of a myeloma specialist I would suggest this is someone whom you should seek for an opinion.
Edna
I am not a doctor and these are questions you must direct at the clinician treating your mother.
I see that your mother was diagnosed in March 2014, has she had any previous treatment? ~If so what?
Please do not worry at this stage when you need to review options and information. Patients on this website cannot decide on treatment decisions, they can only guide the approach you might take to getting as much information as necessary to make an informed decision.
If you feel unhappy with the decisions of your doctor, whom I assume is a myeloma specialist, please seek a second opinion it might help. If you do not have the input of a myeloma specialist I would suggest this is someone whom you should seek for an opinion.
Edna
Re: Starting treatment with trial Rd + Daratumumab
Edna,
She was diagnosed with SMM. No treatment has yet been done.
Docs here in France are not so available because all hospitals and treatments are public and 100% free (French social security system)... So there are ALOT of patients to treat and little time to handle everyone...
She was diagnosed with SMM. No treatment has yet been done.
Docs here in France are not so available because all hospitals and treatments are public and 100% free (French social security system)... So there are ALOT of patients to treat and little time to handle everyone...
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Maro - Who do you know with myeloma?: My mom
- When were you/they diagnosed?: March 2014
- Age at diagnosis: 63
Re: Starting treatment with trial Rd + Daratumumab
Maro
I am in UK, where the health system is also free, but we do have the right to seek second opinions.
However, each country has its own system for funding treatments and deciding on which drugs/ treatments it will fund, these may be political decisions, not just medical ones.
One has to work with the system one has and hope that one gets the best, unless one can afford private health care.
Good luck.
I am in UK, where the health system is also free, but we do have the right to seek second opinions.
However, each country has its own system for funding treatments and deciding on which drugs/ treatments it will fund, these may be political decisions, not just medical ones.
One has to work with the system one has and hope that one gets the best, unless one can afford private health care.
Good luck.
Re: Starting treatment with trial Rd + Daratumumab
Hello Maro,
I think it's good that your mother has the opportunity to participate in this clinical trial, even if she chooses not to. I also can see, however, why it would be difficult to decide whether she should take part in the trial.
I don't know if I feel comfortable recommending to you one way or the other whether your mother should take part in the trial. What I can do, however, is give you some information that may be helpful.
First, if you haven't seen it already, I believe this is the detailed description of the trial you and your mother are considering:
https://clinicaltrials.gov/ct2/show/NCT02252172
It's worth noting that trial participants will know which treatment regimen they are selected to receive, and that the Revlimid and daratumumab will be given to patients in the study until their disease progresses, or until side effects become insurmountable.
Second, although the Mayo Clinic lists t(14;16) as characteristic of high-risk disease, there is some dispute on that point. This is mentioned at the top of the page in the book excerpt at this page:
http://bit.ly/1W18brO
It mentions that a French (!) study found that t(14;16) did not have a negative effect on prognosis. This link will take you to the French study:
http://www.bloodjournal.org/content/bloodjournal/117/6/2009.full.pdf
Some people have wondered whether the results of the French study are influenced by the fact that 60% of the participants in the study received tandem transplants as part of their initial therapy. Unfortunately, the French report does not break out results based on whether or not patients received a transplant as part of their initial treatment.
Finally, keep in mind that, if your mother decides to participate in the study, she will have the option of being treated with VMP whenever she relapses.
I hope this helps a little. Good luck with your decision!
I think it's good that your mother has the opportunity to participate in this clinical trial, even if she chooses not to. I also can see, however, why it would be difficult to decide whether she should take part in the trial.
I don't know if I feel comfortable recommending to you one way or the other whether your mother should take part in the trial. What I can do, however, is give you some information that may be helpful.
First, if you haven't seen it already, I believe this is the detailed description of the trial you and your mother are considering:
https://clinicaltrials.gov/ct2/show/NCT02252172
It's worth noting that trial participants will know which treatment regimen they are selected to receive, and that the Revlimid and daratumumab will be given to patients in the study until their disease progresses, or until side effects become insurmountable.
Second, although the Mayo Clinic lists t(14;16) as characteristic of high-risk disease, there is some dispute on that point. This is mentioned at the top of the page in the book excerpt at this page:
http://bit.ly/1W18brO
It mentions that a French (!) study found that t(14;16) did not have a negative effect on prognosis. This link will take you to the French study:
http://www.bloodjournal.org/content/bloodjournal/117/6/2009.full.pdf
Some people have wondered whether the results of the French study are influenced by the fact that 60% of the participants in the study received tandem transplants as part of their initial therapy. Unfortunately, the French report does not break out results based on whether or not patients received a transplant as part of their initial treatment.
Finally, keep in mind that, if your mother decides to participate in the study, she will have the option of being treated with VMP whenever she relapses.
I hope this helps a little. Good luck with your decision!
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JimNY
Re: Starting treatment with trial Rd + Daratumumab
Bonjour Maro,
Mon papa va peut-être commencer CyBorD (Cyclophosphamide, bortezomib and dexamethasone) bortezomib=Velcade. J'ai des inquiétude, parce-que mon papa a de douleur neurologique au cause d'un plasmatomie de colonne vertébrale
I understand your concerns about MPV (which is common in Europe, from what I understand); I have the same concerns with CyBorD (commonly used in Canada); like France, Canada has a socialized medical system; the Ontario Ministry of Health will only cover Revlimid if another myeloma medication tried first does not work on the patient.
Does your mom have a myeloma specialist or a hematologist?
Mon papa va peut-être commencer CyBorD (Cyclophosphamide, bortezomib and dexamethasone) bortezomib=Velcade. J'ai des inquiétude, parce-que mon papa a de douleur neurologique au cause d'un plasmatomie de colonne vertébrale
I understand your concerns about MPV (which is common in Europe, from what I understand); I have the same concerns with CyBorD (commonly used in Canada); like France, Canada has a socialized medical system; the Ontario Ministry of Health will only cover Revlimid if another myeloma medication tried first does not work on the patient.
Does your mom have a myeloma specialist or a hematologist?
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Little Monkey - Name: Little Monkey
- Who do you know with myeloma?: Father-stage 1 multiple myeloma
- When were you/they diagnosed?: March/April of 2015
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