I have recently been given the go-ahead to undergo my first autologous stem cell transplant (ASCT) in mid-September, and find myself faced with a decision I didn't anticipate. I have been asked to take part in a Phase I/II trial coincident with my ASCT, "Cord Blood Natural Killer Cells for Myeloma" (https://clinicaltrials.gov/ct2/show/NCT01729091).
While I am very interested in taking advantage of every possible advancement in multiple myeloma therapy, I am wondering if anyone else here on the forum has any experience with natural killer cell therapies or has participated in any similar trials. While I would be lying if I said I'm not at all nervous to participate in a Phase I trial, another consideration for me is that my participation may significantly lengthen the amount of time I must be away from home and family (+3 weeks minimum).
Thanks in advance for any and all feedback.
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Re: Cord blood natural killer cell clinical trial
Hi L,
That is a great question / dilemma you raise. While you are the only one who can answer this for yourself, depending on your confidence in your treatment team, the nature of the trial, and your personal situation, I would offer the following for you to consider ...
When I got my ASCT three years ago, there were myeloma cells included in the stem cell collection that went back into me, and 100 days after the transplant there was no change in my M-spike (1.2 g/dL).
While I am doing well on Revlimid maintenance since then, those were nervous days. If I had had a chance to really nail this beast with the kind of trial you are being offered, I would have gone for it, for two reasons. First, it may well benefit you directly and significantly, with minimal risk, and either way you will have helped advance the science. The three week time frame will seem like nothing a year or two from now also.
I am looking for a trial to go into once I relapse, but given the circumstances you describe, if it were me (and I'm 72), I would go for it.
In any case, I wish you and your family all the best going forward,
Eric
That is a great question / dilemma you raise. While you are the only one who can answer this for yourself, depending on your confidence in your treatment team, the nature of the trial, and your personal situation, I would offer the following for you to consider ...
When I got my ASCT three years ago, there were myeloma cells included in the stem cell collection that went back into me, and 100 days after the transplant there was no change in my M-spike (1.2 g/dL).
While I am doing well on Revlimid maintenance since then, those were nervous days. If I had had a chance to really nail this beast with the kind of trial you are being offered, I would have gone for it, for two reasons. First, it may well benefit you directly and significantly, with minimal risk, and either way you will have helped advance the science. The three week time frame will seem like nothing a year or two from now also.
I am looking for a trial to go into once I relapse, but given the circumstances you describe, if it were me (and I'm 72), I would go for it.
In any case, I wish you and your family all the best going forward,
Eric
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blizard49 - Name: Eric
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: March 2012
- Age at diagnosis: 68
Re: Cord blood natural killer cell clinical trial
Hi,
I agree with Eric. It is clearly your decision. But if it were me, I think I would go for it as well. Immunological therapies already have been quite successful with some of the other blood cancers. I cannot see any downside to being in the clinical trial, as even the non-treatment arm receives standard care.
Good luck!
Ginny
I agree with Eric. It is clearly your decision. But if it were me, I think I would go for it as well. Immunological therapies already have been quite successful with some of the other blood cancers. I cannot see any downside to being in the clinical trial, as even the non-treatment arm receives standard care.
Good luck!
Ginny
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Ginny - Name: Ginny
- Who do you know with myeloma?: self and four friends
- When were you/they diagnosed?: October, 2012
- Age at diagnosis: 62
Re: Cord blood natural killer cell clinical trial
I want to just to add to Blizard49's comment:
"The three week time frame will seem like nothing a year or two from now also."
If you think the therapy can be benefit you, in my opinion, that will be a great investment of time. Therapies have the best chance of being successful when applied early in disease course. I spent 29 days in the hospital doing an allogeneic transplant in first complete response. I invested those 29 days plus the time to recover back than for the LONG TERM benefits that a healthy functioning immune system would provide for me
On the other hand, this is a Phase 1 trial so the potential benefits/risks are unknown. I would just try and make a decision on if you think the therapy will be of medical benefit. How would you feel 5 years from now if you saw that a high percentage of patients in this trial got a benefit from the experimental therapy and you did not do it because of the additional 3 weeks of time it would take to get the therapy?
"The three week time frame will seem like nothing a year or two from now also."
If you think the therapy can be benefit you, in my opinion, that will be a great investment of time. Therapies have the best chance of being successful when applied early in disease course. I spent 29 days in the hospital doing an allogeneic transplant in first complete response. I invested those 29 days plus the time to recover back than for the LONG TERM benefits that a healthy functioning immune system would provide for me
On the other hand, this is a Phase 1 trial so the potential benefits/risks are unknown. I would just try and make a decision on if you think the therapy will be of medical benefit. How would you feel 5 years from now if you saw that a high percentage of patients in this trial got a benefit from the experimental therapy and you did not do it because of the additional 3 weeks of time it would take to get the therapy?
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Mark11
Re: Cord blood natural killer cell clinical trial
Lloyd
Yes, the decision is yours and not an easy one at that. We made the decision to enter a clinical trial at MD Anderson that uses natural killer cells in conjunction with an autologous stem cell transplant. Today, my husband received his infusion of melphalan and in two days he will get the natural killer cells. He receives his own stem cells in another six days.
We made the decision to enter the clinical trial because my husband's multiple myeloma appears to be aggressive. He is a bit older than you (65), so we feel that we need to get it under control sooner rather than later.
Finally, after all the reading, research, and seminars, we feel we made an informed decision to enter the trial. I will be very happy to keep you posted on his progress. I wish you well regardless of your decision.
Yes, the decision is yours and not an easy one at that. We made the decision to enter a clinical trial at MD Anderson that uses natural killer cells in conjunction with an autologous stem cell transplant. Today, my husband received his infusion of melphalan and in two days he will get the natural killer cells. He receives his own stem cells in another six days.
We made the decision to enter the clinical trial because my husband's multiple myeloma appears to be aggressive. He is a bit older than you (65), so we feel that we need to get it under control sooner rather than later.
Finally, after all the reading, research, and seminars, we feel we made an informed decision to enter the trial. I will be very happy to keep you posted on his progress. I wish you well regardless of your decision.
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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
Re: Cord blood natural killer cell clinical trial
blizard49, Ginny, Mark11, PattyB:
Thanks to all for the feedback. Upon further research on my part, combined with the thoughtful feedback from this forum, I have decided to move forward with the trial.
PattyB: I wish you and your husband nothing but good luck with his ASCT and trial.
Lloyd
Thanks to all for the feedback. Upon further research on my part, combined with the thoughtful feedback from this forum, I have decided to move forward with the trial.
PattyB: I wish you and your husband nothing but good luck with his ASCT and trial.
Lloyd
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LCharlier - Name: Lloyd
- When were you/they diagnosed?: 01-16-2015
- Age at diagnosis: 55
Re: Cord blood natural killer cell clinical trial
Lloyd, good luck with your participation in the study. I have a done a good deal of research on several of the immunotherapy options, but I did not want to comment on the cord blood natural killer cells, as that was something I did not have the chance to look at in detail. I did want to add some general comments regarding immunotherapy, and its potential benefit, looking down the road, after several questions have been answered in current and future clinical trials.
Results of allo transplants (which is in fact an immunotherapy) has shown that the new immune system can potentially wipe out the myeloma in some cases, if caught early on. That has lead to several studies with the concept of immunotherapy to treat myeloma. Some of the early T-Cell trials illustrated the potential for serious problems such as a type of graft vs host disease, or a very serious all-body reaction known as "cytokine storm", where the high fever alone could be a very serious problem. At present, the CAR T-cell clinical trials, all done very carefully, look to "target" the bad myeloma cells, without harming any good cells or tissue in the body. That appears to be the case in the more recent studies that have published interim results, but each new T Cell study with a new target will need to be carefully evaluated.
There has been a new class of myeloma vaccines that are not entire T-cells, but small protein strings that are "expressed" on myeloma. These are called "peptide" vaccines. Two examples of this are the WT-1 peptide and the oncofetal antigen peptide vaccines. These are given in enough dose that the immune system attacks them. The peptides also exist on the surface of myeloma cells, so the vaccine causes the body to also attack the myeloma cells. These are being studied right now at several major centers. Dr. Ken Anderson, for example, at Dana Farber has spoken on the promise of this approach. The thing with peptide vaccines is that the side effects tend to be in the nature of a flu shot or a measles shot (probably an oversimplification), and very rarely has serious side effects. My very quick read seems to indicate that the cord blood NK cells have the side effect profile closer to the peptides, in results published so far.
Generally, when reviewing the different study results for immunotherapy, there does appear that there is usually a pretty decent overall response, some people with an outstanding response, some with a clear, but limited clinical benefit, but a lot of people with mediocre or no response. The reason for this is that the myeloma cells are very different from person to person and within a person (and in fact changes in each person over time). Another level of complexity is that when you characterize the myeloma cells, typically not all of them have the same characteristic, and only a portion may "express" a given target. The result is that a single treatment of peptide vaccine or Tcell may only attack some of in individual's myeloma cells, but not all.
Down the road, however, more and more immunotherapy treatments will be evaluated. There is no reason why the treatments could not be given with a vaccine "cocktail". The cocktail could have 3 or 5 or 7 different agents in it, and the cocktail could be mixed to have a very good result in the vast majority of patients. The cocktail could potentially be altered based on a FISH or similar test, to specifically target an individual's characteristic of myeloma. In fact, MSKCC has a clinical trial with a mix of 3 peptide agents. Here is the link:
https://www.mskcc.org/cancer-care/clinical-trials/13-009
This trial is still recruiting (last I checked), and will not post results for a while. Down the road, based on results of research in individual trials, the individual immunotherapy agents will be evaluated for effectiveness, and will be combined in a more optimal manner.
Accordingly, a far off possibility is an immunotherapy treatment approach that has a similar response (eventually even a better response) to existing standard of care, and the first round of induction will be immunotherapy agents with much lower side effects than the existing regimen (RVD for example). Then the RVD would not be needed until several years down the road.
On the plus side for immunotherapy, also, is that fact that a chemotherapy may be active in the body for maybe two weeks, but an immunotherapy "response" may persist. Peptide vaccines tend to loose any effect after about one to two years. So far, they do not at all seem to remain active for 40 or 50 years like the measles vaccine. On the other hand, you need to "boost" your tetanus shot every 5 years, and eventually they may work that out in this case as well.
There are a lot more interesting immunotherapy details that I could get into, but enough for now. I am rambling on in this thread to bring home the a point that this promise will only be realized as a result of individuals participating in clinical trials in the area of immunotherapy. So great job to Lloyd and others like him who have made the decision to do so. On the other side, I would advise anyone to take a very good look at the trials available, and only move forward if you are comfortable. If you get the feeling that it is not a match, or you feel like a guinea pig, do not do it. But if you come across an immunotherapy option, I would give it a very close look.
Best of luck to all.
Results of allo transplants (which is in fact an immunotherapy) has shown that the new immune system can potentially wipe out the myeloma in some cases, if caught early on. That has lead to several studies with the concept of immunotherapy to treat myeloma. Some of the early T-Cell trials illustrated the potential for serious problems such as a type of graft vs host disease, or a very serious all-body reaction known as "cytokine storm", where the high fever alone could be a very serious problem. At present, the CAR T-cell clinical trials, all done very carefully, look to "target" the bad myeloma cells, without harming any good cells or tissue in the body. That appears to be the case in the more recent studies that have published interim results, but each new T Cell study with a new target will need to be carefully evaluated.
There has been a new class of myeloma vaccines that are not entire T-cells, but small protein strings that are "expressed" on myeloma. These are called "peptide" vaccines. Two examples of this are the WT-1 peptide and the oncofetal antigen peptide vaccines. These are given in enough dose that the immune system attacks them. The peptides also exist on the surface of myeloma cells, so the vaccine causes the body to also attack the myeloma cells. These are being studied right now at several major centers. Dr. Ken Anderson, for example, at Dana Farber has spoken on the promise of this approach. The thing with peptide vaccines is that the side effects tend to be in the nature of a flu shot or a measles shot (probably an oversimplification), and very rarely has serious side effects. My very quick read seems to indicate that the cord blood NK cells have the side effect profile closer to the peptides, in results published so far.
Generally, when reviewing the different study results for immunotherapy, there does appear that there is usually a pretty decent overall response, some people with an outstanding response, some with a clear, but limited clinical benefit, but a lot of people with mediocre or no response. The reason for this is that the myeloma cells are very different from person to person and within a person (and in fact changes in each person over time). Another level of complexity is that when you characterize the myeloma cells, typically not all of them have the same characteristic, and only a portion may "express" a given target. The result is that a single treatment of peptide vaccine or Tcell may only attack some of in individual's myeloma cells, but not all.
Down the road, however, more and more immunotherapy treatments will be evaluated. There is no reason why the treatments could not be given with a vaccine "cocktail". The cocktail could have 3 or 5 or 7 different agents in it, and the cocktail could be mixed to have a very good result in the vast majority of patients. The cocktail could potentially be altered based on a FISH or similar test, to specifically target an individual's characteristic of myeloma. In fact, MSKCC has a clinical trial with a mix of 3 peptide agents. Here is the link:
https://www.mskcc.org/cancer-care/clinical-trials/13-009
This trial is still recruiting (last I checked), and will not post results for a while. Down the road, based on results of research in individual trials, the individual immunotherapy agents will be evaluated for effectiveness, and will be combined in a more optimal manner.
Accordingly, a far off possibility is an immunotherapy treatment approach that has a similar response (eventually even a better response) to existing standard of care, and the first round of induction will be immunotherapy agents with much lower side effects than the existing regimen (RVD for example). Then the RVD would not be needed until several years down the road.
On the plus side for immunotherapy, also, is that fact that a chemotherapy may be active in the body for maybe two weeks, but an immunotherapy "response" may persist. Peptide vaccines tend to loose any effect after about one to two years. So far, they do not at all seem to remain active for 40 or 50 years like the measles vaccine. On the other hand, you need to "boost" your tetanus shot every 5 years, and eventually they may work that out in this case as well.
There are a lot more interesting immunotherapy details that I could get into, but enough for now. I am rambling on in this thread to bring home the a point that this promise will only be realized as a result of individuals participating in clinical trials in the area of immunotherapy. So great job to Lloyd and others like him who have made the decision to do so. On the other side, I would advise anyone to take a very good look at the trials available, and only move forward if you are comfortable. If you get the feeling that it is not a match, or you feel like a guinea pig, do not do it. But if you come across an immunotherapy option, I would give it a very close look.
Best of luck to all.
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JPC - Name: JPC
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