Hello everyone
I have been posting regularly on the forum and many of you have helped with encouraging words and advice.
My mother was diagnosed in France with smoldering multiple myeloma with a 50% plasma cell percentage on bone marrow biopsy (BMB), IgA lambda with M-spike 18 g/L (1.8 g/dL) in March of 2014.
For the past 15 months, we have undergone bloodwork in the "watch and wait" process of smoldering myeloma.
However, our last appointment with our onco was pretty devastating, since he told us that there is a clear sign of evolution. M-spike has gradually risen to 31.6 g/L (3.16 g/dL) and hemoglobin has dropped to 10.5.
He is now suggesting we begin treatment as my mother is considered to be a high risk case of SMM.
We have 2 options, one of which may be of interest to the Beacon since it will be a clinical trial of daratumumab (I will give further details below).
A new MRI is to be done end of June to assess her current state with precision.
Here are the current options we have:
1. Daratumumab trial
A clinical trial starting sometime this summer which we can enroll for IF and ONLY IF my mother is still classified as smoldering. The MRI will determine this, but it is likely that she may fit in. The trial will be the use of daratumumab in smoldering myeloma to determine whether or not it can be beneficial in delaying the progression to symptomatic multiple myeloma. As many of you may know, there is a lot of hope regarding these new immunotherapy drugs, and we are considering to give it a go if we are eligible.
I would be glad to keep you all updated on this trial if we are enrolled for it, since I know we may be the first ones to undergo this trial.
2. Treatment with VTD
If my mother is not eligible for the trial (in case she has signs of lesions on MRI, etc.) then the doctor will start us on VTD (Velcade, thalidomide, dex).
This worries me. Is this a good treatment? I noticed from the current weekly polls that in the USA the majority of multiple myeloma patients start with Revlimid, Velcade, and dex (RVD) or cyclophosphamide, Velcade, and dex (CyBorD).
Why do we use VTD in France? Does it work? How does it compare to RVD or CyBorD.
I really need your thoughts on the matter.
All form of advice or feedback regarding our case would be very highly appreciated.
Wishing you all well,
Maro.
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May start daratumumab smoldering myeloma trial
Last edited by Maro on Wed Jun 17, 2015 1:04 pm, edited 1 time in total.
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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: May start daratumumab smoldering myeloma trial
Brief recap of my mom's lab works:
============ June 2015 exams ============
Hemoblogin 105 g/l or 10.5g/dL
Leucoytes 3.78 giga/L
Hematies 3.24 tera/L
Albumin 35.9 g/l
Creatinine 71 umol/l (normal range 45-84)
Calcium 2.32 mmol/l or 93 mg/l
(Calcium normal range) (2.2-2.55 mmol/l or 88.2-102.3 g/l)
M-spikes
Beta M-spike 24.6 g/L or 2.46g/dL
Gamma M-spike 7 g/L or 0.7g/dL
Total 31.6 g/L or 3.16g/dL
IGA type SMM.
============ February 2015 exams ============
Hemoblogin 110 g/l or 11.0g/dL
Leucoytes 4.55 giga/L
Hematies 3.45 tera/L
Albumin 40.6 g/l
Creatinine 81 umol/l (normal range 45-84)
Calcium 2.31 mmol/l or 92.6 mg/l
(Calcium normal range) (2.2-2.55 mmol/l or 88.2-102.3 g/l)
M-spikes
Beta M-spike 20 g/L or 2g/dL
Gamma M-spike 5.5 g/L or 0.55g/dL
Total 25.5 g/L or 2.55g/dL
============October 2014 exams ============
Hemoblogin 116 g/l or 11.6g/dL
Leucoytes 3.97 giga/L
Hematies 3.81 tera/L
Albumin 38.4 g/l
Creatinine 70 umol/l (normal range 45-84)
Renal function Cockroft 63.2 ml/mn (must be over 60)
Renal function MDRD 77.8 ml/mn (must be over 60)
Calcium 2.39 mmol/l or 95.8 mg/l
(Calcium normal range) (2.2-2.55 mmol/l or 88.2-102.3 g/l)
M-spikes
Beta M-spike 17.5 g/L or 1.75g/dL
Gamma M-spike 5.6 g/L or 0.56g/dL
Total 23.1 g/L or 2.31g/dL
============July 2014 exams ============
Hemoblogin 117 g/l or 11.7g/dL
Leucoytes 5.2 giga/L
Hematies 3.77 tera/L
Albumin 39.3g/l
Creatinine 64 umol/l
Renal function Cockroft 70.4 ml/mn
Renal function MDRD 86.3 ml/mn
Calcium 2.30 mmol/l
M-Spikes
Beta M-spike 15.0 g/L or 1.50 g/dL
Gamma M-spike 5.5 g/L or 0.55 g/dL
Total 20.5 g/L or 2.05 g/dL
============ February 2014 exams ============
Hemoblogin 115 g/l or 11.5 g/dL
Albumin 38,6 g/l
Creatinine 73 umol/l
Renal function Cockroft 61.6 ml/mn
Renal function MDRD 74.4 ml/mn
Calcium 2.43 mmol/l
M-spikes
Beta M-spike 14.2 g/L or 1.42 g/dL
Gamma M-spike 4.3 g/L or 0.43 g/dL
Total 18.5 g/L or 1.85 g/dL
============ June 2015 exams ============
Hemoblogin 105 g/l or 10.5g/dL
Leucoytes 3.78 giga/L
Hematies 3.24 tera/L
Albumin 35.9 g/l
Creatinine 71 umol/l (normal range 45-84)
Calcium 2.32 mmol/l or 93 mg/l
(Calcium normal range) (2.2-2.55 mmol/l or 88.2-102.3 g/l)
M-spikes
Beta M-spike 24.6 g/L or 2.46g/dL
Gamma M-spike 7 g/L or 0.7g/dL
Total 31.6 g/L or 3.16g/dL
IGA type SMM.
============ February 2015 exams ============
Hemoblogin 110 g/l or 11.0g/dL
Leucoytes 4.55 giga/L
Hematies 3.45 tera/L
Albumin 40.6 g/l
Creatinine 81 umol/l (normal range 45-84)
Calcium 2.31 mmol/l or 92.6 mg/l
(Calcium normal range) (2.2-2.55 mmol/l or 88.2-102.3 g/l)
M-spikes
Beta M-spike 20 g/L or 2g/dL
Gamma M-spike 5.5 g/L or 0.55g/dL
Total 25.5 g/L or 2.55g/dL
============October 2014 exams ============
Hemoblogin 116 g/l or 11.6g/dL
Leucoytes 3.97 giga/L
Hematies 3.81 tera/L
Albumin 38.4 g/l
Creatinine 70 umol/l (normal range 45-84)
Renal function Cockroft 63.2 ml/mn (must be over 60)
Renal function MDRD 77.8 ml/mn (must be over 60)
Calcium 2.39 mmol/l or 95.8 mg/l
(Calcium normal range) (2.2-2.55 mmol/l or 88.2-102.3 g/l)
M-spikes
Beta M-spike 17.5 g/L or 1.75g/dL
Gamma M-spike 5.6 g/L or 0.56g/dL
Total 23.1 g/L or 2.31g/dL
============July 2014 exams ============
Hemoblogin 117 g/l or 11.7g/dL
Leucoytes 5.2 giga/L
Hematies 3.77 tera/L
Albumin 39.3g/l
Creatinine 64 umol/l
Renal function Cockroft 70.4 ml/mn
Renal function MDRD 86.3 ml/mn
Calcium 2.30 mmol/l
M-Spikes
Beta M-spike 15.0 g/L or 1.50 g/dL
Gamma M-spike 5.5 g/L or 0.55 g/dL
Total 20.5 g/L or 2.05 g/dL
============ February 2014 exams ============
Hemoblogin 115 g/l or 11.5 g/dL
Albumin 38,6 g/l
Creatinine 73 umol/l
Renal function Cockroft 61.6 ml/mn
Renal function MDRD 74.4 ml/mn
Calcium 2.43 mmol/l
M-spikes
Beta M-spike 14.2 g/L or 1.42 g/dL
Gamma M-spike 4.3 g/L or 0.43 g/dL
Total 18.5 g/L or 1.85 g/dL
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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: May start daratumumab smoldering myeloma trial
Hello Maro,
Unfortunately, it does look like your mother's myeloma is progressing. Her M-spike is increasing and her hemoglobin is dropping. In fact, in another couple of months, her hemoglobin level may be below 10, which I believe would mean that she meets the "A" in the traditional "CRAB" criteria for having symptomatic multiple myeloma.
What is interesting in your mother's case is that the disease does not seem to be causing much bone damage. It seems to be primarily in her bone marrow, limiting her production of red blood cells and also her white blood cells. Her calcium and creatinine levels are not rock steady, but they don't seem to be trending as much in a bad direction as, say, her hemoglobin or M-spike numbers.
This is good, because it means that your mother is not likely to suffer kidney damage or very bad bone damage, which is important for both her long-term prognosis and her quality of life.
Daratumumab would be an excellent option if your mother were to be treated while technically still smoldering. As you probably have seen, it is showing some very strong anti-myeloma activity.
You are correct that RVD is a very common treatment regimen in the US, but not in other countries. The main reason for this is that in no country is that treatment regimen officially approved as a first-line therapy for multiple myeloma. Here in the US, official approval is not that critical. "Off label" prescribing is generally permitted and very common. In many (most) other countries, on the other hand, off label prescribing is not generally permitted. Why that is the case is a topic for a much longer discussion.
You will find different opinions on whether or not RVD is better than VTD. If you compared treatment with the two regimens for, say, 4-6 cycles of treatment, I personally suspect response rates and progression-free survival would be similar for the two regimens. But this is only a guess; I don't think there has been any head-to-head comparison of the two regimens. I also should add that many doctors here would probably say that RVD is more effective than VTD, even if you did a true apples-to-apples comparison.
I think doctors here prefer RVD because you don't see as much peripheral neuropathy with it as you do with VTD, and that allows you to treat patients with it longer, which can generate deeper responses to treatment. (Both Revlimid and thalidomide can cause some neuropathy, but thalidomide is more likely to cause it, and the neuropathy from thalidomide has a reputation for being persistent, rather than transient.)
I wish you and your mother the best of luck as you go forward. Please keep us updated on how things are going.
Unfortunately, it does look like your mother's myeloma is progressing. Her M-spike is increasing and her hemoglobin is dropping. In fact, in another couple of months, her hemoglobin level may be below 10, which I believe would mean that she meets the "A" in the traditional "CRAB" criteria for having symptomatic multiple myeloma.
What is interesting in your mother's case is that the disease does not seem to be causing much bone damage. It seems to be primarily in her bone marrow, limiting her production of red blood cells and also her white blood cells. Her calcium and creatinine levels are not rock steady, but they don't seem to be trending as much in a bad direction as, say, her hemoglobin or M-spike numbers.
This is good, because it means that your mother is not likely to suffer kidney damage or very bad bone damage, which is important for both her long-term prognosis and her quality of life.
Daratumumab would be an excellent option if your mother were to be treated while technically still smoldering. As you probably have seen, it is showing some very strong anti-myeloma activity.
You are correct that RVD is a very common treatment regimen in the US, but not in other countries. The main reason for this is that in no country is that treatment regimen officially approved as a first-line therapy for multiple myeloma. Here in the US, official approval is not that critical. "Off label" prescribing is generally permitted and very common. In many (most) other countries, on the other hand, off label prescribing is not generally permitted. Why that is the case is a topic for a much longer discussion.
You will find different opinions on whether or not RVD is better than VTD. If you compared treatment with the two regimens for, say, 4-6 cycles of treatment, I personally suspect response rates and progression-free survival would be similar for the two regimens. But this is only a guess; I don't think there has been any head-to-head comparison of the two regimens. I also should add that many doctors here would probably say that RVD is more effective than VTD, even if you did a true apples-to-apples comparison.
I think doctors here prefer RVD because you don't see as much peripheral neuropathy with it as you do with VTD, and that allows you to treat patients with it longer, which can generate deeper responses to treatment. (Both Revlimid and thalidomide can cause some neuropathy, but thalidomide is more likely to cause it, and the neuropathy from thalidomide has a reputation for being persistent, rather than transient.)
I wish you and your mother the best of luck as you go forward. Please keep us updated on how things are going.
Re: May start daratumumab smoldering myeloma trial
Hi.
It would be interesting to know more about this trial, as my kappa values are rather high, giving a ratio in the area of 150.
Is this exclusively a French trial? I live in Norway.
Best regards,
John
It would be interesting to know more about this trial, as my kappa values are rather high, giving a ratio in the area of 150.
Is this exclusively a French trial? I live in Norway.
Best regards,
John
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JohnC - Name: JohnC
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: April 2014
- Age at diagnosis: 47
Re: May start daratumumab smoldering myeloma trial
Hello John
This is the website regarding all clinical trials all over the world:
http://clinicaltrials.gov
The daratumumab trial link is: https://clinicaltrials.gov/ct2/show/NCT02316106
I had a look at the locations and unfortunately I have not seen Norway in the list of locations where the trial will take place.
You can however ask your doctor just in case because I am not totally sure if the absence of Norway on that website necessarily means that Norway won't participate in a similar clinical trial.
Best of luck.
This is the website regarding all clinical trials all over the world:
http://clinicaltrials.gov
The daratumumab trial link is: https://clinicaltrials.gov/ct2/show/NCT02316106
I had a look at the locations and unfortunately I have not seen Norway in the list of locations where the trial will take place.
You can however ask your doctor just in case because I am not totally sure if the absence of Norway on that website necessarily means that Norway won't participate in a similar clinical trial.
Best of luck.
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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: May start daratumumab smoldering myeloma trial
Bonjour Maro! I think I may have been the first person you wrote to on the Beacon, and I do read your posts about your mother's health. Whatever way you choose to go for treatment, am wishing you all the best.
Daratumumab trials are ongoing where I live also, and people have high hopes that the drug will help many people, but I have no personal experience of it.
When you asked as to why the initial therapies differ between France and the U.S., I think that JimNY gave you a good answer. 'Off label' use of drugs is allowed there.
One thing to consider for initial therapies is whether or not the patient is intending to have an autologous stem cell transplant. In Canada, there is an application now to have Revlimid used for initial treatment for patients who are NOT planning to do a transplant. You can see how complicated it can get, since the health agencies want 'evidence based' studies (phase 3 clinical trial data) in order to approve any treatment, or any change of 'indications' for treatment. A change of indications means that the drug can be used for a different purpose than it was originally approved for.
Confused? Maybe if you have time you can look up just what is approved in France. Another factor is that you may have different health regions in France, all of which may have differing approvals. That is how it is in Canada!
I think that your mother is fortunate to have you so concerned with her health, and that you are in a good position to delve into the French health care system too!
Daratumumab trials are ongoing where I live also, and people have high hopes that the drug will help many people, but I have no personal experience of it.
When you asked as to why the initial therapies differ between France and the U.S., I think that JimNY gave you a good answer. 'Off label' use of drugs is allowed there.
One thing to consider for initial therapies is whether or not the patient is intending to have an autologous stem cell transplant. In Canada, there is an application now to have Revlimid used for initial treatment for patients who are NOT planning to do a transplant. You can see how complicated it can get, since the health agencies want 'evidence based' studies (phase 3 clinical trial data) in order to approve any treatment, or any change of 'indications' for treatment. A change of indications means that the drug can be used for a different purpose than it was originally approved for.
Confused? Maybe if you have time you can look up just what is approved in France. Another factor is that you may have different health regions in France, all of which may have differing approvals. That is how it is in Canada!
I think that your mother is fortunate to have you so concerned with her health, and that you are in a good position to delve into the French health care system too!
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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: May start daratumumab smoldering myeloma trial
Thank you, Maro, for providing the links.
I will use that for further investigating on the issue.
I will use that for further investigating on the issue.
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JohnC - Name: JohnC
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: April 2014
- Age at diagnosis: 47
Re: May start daratumumab smoldering myeloma trial
MRI results came out. 2 bone lesions in the lower back have shown unfortunately.
The ok news is that the myeloma has not spread up the spine.
My mother will probably be starting on VTD soon.
What are your thoughts? Can she achieve good results on Velcade, thalidomide, and dex?
Worried. Can barely sleep.
The ok news is that the myeloma has not spread up the spine.
My mother will probably be starting on VTD soon.
What are your thoughts? Can she achieve good results on Velcade, thalidomide, and dex?
Worried. Can barely sleep.
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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: May start daratumumab smoldering myeloma trial
Hello Maro,
I'm very sorry to hear that lesions were found in your mom's back and that it's now clear that her smoldering myeloma has progressed.
Just about any combination of a proteasome inhibitor (like Velcade) and an immunomodulatory agent (like thalidomide), together with dexamethasone, is effective as a myeloma treatment. So your mother is likely to respond well to the treatment.
The one thing that you and your mother will have to watch out for is peripheral neuropathy (PN). Both Velcade and thalidomide are known for causing PN, but your mother's doctors can do things like change the dosing of the drugs if PN starts to occur so that she can continue treatment with the regimen.
Also, it's common these days to give Velcade as an injection under the skin, rather than as an infusion, to lower the chances of it causing PN. You probably should check with your mother's doctor to see whether the plan is to give Velcade as an injection or as an infusion.
It is good that your mother's myeloma has been watched carefully over the past year so that it could be caught before it did any significant damage to her body. This will probably increase her treatment options since she doesn't have to worry about, for example, reduced kidney function.
Also, as I'm sure you are aware, there have been a number of new myeloma therapies introduced in the past few years, and many more are just around the corner. So your mother will have even more treatment options in the near future.
Good luck!
I'm very sorry to hear that lesions were found in your mom's back and that it's now clear that her smoldering myeloma has progressed.
Just about any combination of a proteasome inhibitor (like Velcade) and an immunomodulatory agent (like thalidomide), together with dexamethasone, is effective as a myeloma treatment. So your mother is likely to respond well to the treatment.
The one thing that you and your mother will have to watch out for is peripheral neuropathy (PN). Both Velcade and thalidomide are known for causing PN, but your mother's doctors can do things like change the dosing of the drugs if PN starts to occur so that she can continue treatment with the regimen.
Also, it's common these days to give Velcade as an injection under the skin, rather than as an infusion, to lower the chances of it causing PN. You probably should check with your mother's doctor to see whether the plan is to give Velcade as an injection or as an infusion.
It is good that your mother's myeloma has been watched carefully over the past year so that it could be caught before it did any significant damage to her body. This will probably increase her treatment options since she doesn't have to worry about, for example, reduced kidney function.
Also, as I'm sure you are aware, there have been a number of new myeloma therapies introduced in the past few years, and many more are just around the corner. So your mother will have even more treatment options in the near future.
Good luck!
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