My colleagues and I earlier today received word about information that had been posted elsewhere on the Internet about initial results from the Phase 2 portion of the Mayo Clinic’s clinical trial testing measles virotherapy for relapsed multiple myeloma.
The information was from at least one participant in the trial, who wrote that they had been told that, thus far, there had been few – if any – responses among the initial participants in the Phase 2 trial.
My colleagues and I felt uncomfortable passing along this information without any further confirmation of it. So I reached out to Beacon Medical Advisor Dr. Prashant Kapoor, who, as many of you know, is a myeloma specialist at the Mayo Clinic.
Dr. Kapoor, in turn, has informed us that the principal investigators leading the Phase 2 trial have confirmed that there were, indeed, no responses to the vaccine therapy observed in the first 12 patients treated in the Phase 2 portion of the trial.
The investigators also added, however, that the results have not been formally analyzed, released, or presented, although some patients in the trial were counseled about the results.
Despite these initial results from the Phase 2 part of the trial, the investigators say that they remain very enthusiastic about the measles virotherapy approach, and they have identified certain factors to be considered for the next trial cohort. The trial will therefore be amended and accrual of additional patients will resume with revisions.
For further information about the Mayo Clinic trial and initial results from the Phase 1 portion of it, see the extended Beacon forum thread on the topic, "Mayo Clinic measles vaccine study" (started May 14, 2014).
I know that this update will come as a disappointment to many in the multiple myeloma community. I wish the news that we had to pass along were considerably more positive.
Those of you who are regular Beacon readers and participants here in the forum, however, know that there are many other new therapies under development for multiple myeloma. Some of these therapies, in fact, are just around the corner in terms of being available to patients outside of clinical trials.
It also is still very much an open question what the final results of the measles virotherapy will be, as researchers are continuing to learn more about this novel approach to cancer treatment.
Thus, while the news in this posting could have been more positive, I hope it won't cause our community to forget the significant progress that is happening on many fronts – and almost every day – when it comes to developing better ways to treat multiple myeloma.
All the best,
Boris.
Forums
Re: Phase 2 of Mayo measles trial - informal initial results
Thank you for this important update.
I think the results seen so far in the Phase II portion of the trial underscore why the clinical trial process is designed the way it is, and how important that process is. Particularly for a disease that is as difficult to treat as multiple myeloma, it is so easy for patients, and even doctors, to latch on to promising results such as what was seen in the single patient whose response in the Phase I part of the trial was so dramatic. We all want to believe that a dramatically more effective new treatment has been found for this disease.
Without additional testing, however, we can't know for certain whether individual success stories are reflective of how other patients are likely to respond to a treatment. There is also the issue that the course of the disease is not perfectly predictable, and what may seem like responses to treatment may actually be the result of other forces.
All of this also has a bearing, of course, on the value of anecdotes about the success of supplements or alternative "therapies" in "treating" myeloma.
I look forward to hearing more about the trial, and I hope the researchers are successful in determining ways to make the treatment effective on a consistent basis.
I think the results seen so far in the Phase II portion of the trial underscore why the clinical trial process is designed the way it is, and how important that process is. Particularly for a disease that is as difficult to treat as multiple myeloma, it is so easy for patients, and even doctors, to latch on to promising results such as what was seen in the single patient whose response in the Phase I part of the trial was so dramatic. We all want to believe that a dramatically more effective new treatment has been found for this disease.
Without additional testing, however, we can't know for certain whether individual success stories are reflective of how other patients are likely to respond to a treatment. There is also the issue that the course of the disease is not perfectly predictable, and what may seem like responses to treatment may actually be the result of other forces.
All of this also has a bearing, of course, on the value of anecdotes about the success of supplements or alternative "therapies" in "treating" myeloma.
I look forward to hearing more about the trial, and I hope the researchers are successful in determining ways to make the treatment effective on a consistent basis.
Re: Phase 2 of Mayo measles trial - informal initial results
Well said Ian.
Boris, as always, this forum is in your team's debt for being in the unique position to get these sorts of important updates. Like Ian, I hope that the investigating teams find the right spin to make this therapy work for multiple myeloma patients.
However, I must say that I am bit surprised to hear about these very preliminary Phase 2 results based on Stacy's story, which has been written about so much and was discussed in the video posted by DallasGG on Sunday.
Was Stacy a unique subject that was uniquely receptive to this therapy or were the Phase-2 test conditions different from what she experienced? I imagine we will have to wait a bit to better understand these kind of details, but these are the things I am curious about.
Boris, as always, this forum is in your team's debt for being in the unique position to get these sorts of important updates. Like Ian, I hope that the investigating teams find the right spin to make this therapy work for multiple myeloma patients.
However, I must say that I am bit surprised to hear about these very preliminary Phase 2 results based on Stacy's story, which has been written about so much and was discussed in the video posted by DallasGG on Sunday.
Was Stacy a unique subject that was uniquely receptive to this therapy or were the Phase-2 test conditions different from what she experienced? I imagine we will have to wait a bit to better understand these kind of details, but these are the things I am curious about.
Last edited by Multibilly on Tue Mar 03, 2015 12:17 pm, edited 1 time in total.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Phase 2 of Mayo measles trial - informal initial results
Thanks for the comments, Ian and Multibilly.
To your questions, Multibilly, I think it's too early at this point to know why Stacy responded as well as she did to the therapy, and whether her experience – combined with the initial results from the Phase 2 part of the trial – can improve the therapy. I'm sure that is what the researchers are trying to do, but it's obviously a challenging task.
Given how long it takes to produce and schedule documentaries such as the HBO video that DallasGG posted, and given how rapidly the Mayo trial has been advancing, I suspect the video was completed before the initial, preliminary results of the Phase 2 part of the trial were known.
I'll continue to post additional information about the Phase 2 portion of the trial as we learn them and can confirm them with people at the Mayo Clinic.
To your questions, Multibilly, I think it's too early at this point to know why Stacy responded as well as she did to the therapy, and whether her experience – combined with the initial results from the Phase 2 part of the trial – can improve the therapy. I'm sure that is what the researchers are trying to do, but it's obviously a challenging task.
Given how long it takes to produce and schedule documentaries such as the HBO video that DallasGG posted, and given how rapidly the Mayo trial has been advancing, I suspect the video was completed before the initial, preliminary results of the Phase 2 part of the trial were known.
I'll continue to post additional information about the Phase 2 portion of the trial as we learn them and can confirm them with people at the Mayo Clinic.
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Boris Simkovich - Name: Boris Simkovich
Founder
The Myeloma Beacon
Re: Phase 2 of Mayo measles trial - informal initial results
Sorry to see this news.
I was just reading the clinical trial description in more detail. I notice that, in the first phase of the study, patients received either the virotherapy alone, or the virotherapy combined with cyclophosphamide. In the second phase, on the other hand, patients were supposed to be given just the virotherapy.
Does anyone know if Stacy received just the virotherapy, or the virotherapy combined with cyclophosphamide?
The trial description says the following:
"Patients are assigned to 1 of 2 treatment arms (Stage 1 or Stage 2) in phase I and assigned to Stage 1 in phase II."
The two stages of the trial are described as follows:
Stage 1: "Patients receive MV-NIS IV over 1 hour on day 1."
Stage 2: "Patients receive cyclophosphamide IV over 30 minutes 2 days before MV-NIS IV is administered over 1 hour on day 1."
I was just reading the clinical trial description in more detail. I notice that, in the first phase of the study, patients received either the virotherapy alone, or the virotherapy combined with cyclophosphamide. In the second phase, on the other hand, patients were supposed to be given just the virotherapy.
Does anyone know if Stacy received just the virotherapy, or the virotherapy combined with cyclophosphamide?
The trial description says the following:
"Patients are assigned to 1 of 2 treatment arms (Stage 1 or Stage 2) in phase I and assigned to Stage 1 in phase II."
The two stages of the trial are described as follows:
Stage 1: "Patients receive MV-NIS IV over 1 hour on day 1."
Stage 2: "Patients receive cyclophosphamide IV over 30 minutes 2 days before MV-NIS IV is administered over 1 hour on day 1."
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JimNY
Re: Phase 2 of Mayo measles trial - informal initial results
My partner was in the measles trial. Though we are personally disappointed in the results for our cohort, we also know that the researchers will use this setback to better understand the potential of this line of research.
Dan is now in home hospice, and starting to wind down. We continue to be grateful to have been part of a study that may possibly lead to a successful treatment. I also want to say how much we appreciate the positive and practical tone of this Beacon post and the thoughtful comments on this thread.
I was going to stop there, but something else is on my mind.
Perhaps I have missed it somewhere on the site, but would like to see this same sort of thoughtful writing in an article about the option to stop treatment. Balancing quality and quantity has always been part of our conversation, but seems to not be part of the general conversation in the United States. The measles trial held the possibility of life without chemotherapy: we were not interested in trying more drugs that would offer (maybe) time but certainly not quality.
Dan is now in home hospice, and starting to wind down. We continue to be grateful to have been part of a study that may possibly lead to a successful treatment. I also want to say how much we appreciate the positive and practical tone of this Beacon post and the thoughtful comments on this thread.
I was going to stop there, but something else is on my mind.
Perhaps I have missed it somewhere on the site, but would like to see this same sort of thoughtful writing in an article about the option to stop treatment. Balancing quality and quantity has always been part of our conversation, but seems to not be part of the general conversation in the United States. The measles trial held the possibility of life without chemotherapy: we were not interested in trying more drugs that would offer (maybe) time but certainly not quality.
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Tib Shaw
Re: Phase 2 of Mayo measles trial - informal initial results
Tib - I am sorry to hear the therapy did not work for Dan. Your segment in the HBO video with Dan and the other couple in the hospital room were touching and powerful segments. Thank you for not stopping and writing that last paragraph. I could not agree more with those last 2 sentences.
Boris - I first want to echo Multibilly's comments about the great job you do here at the Beacon. It is great that you followed up on this story. You all are an unbelievable resource for the myeloma community.
Great post by Ian. When trying new, innovative approaches to treating cancer, investigators often run into problems. With a difficult to treat disease like myeloma it is doubtful there will be a "one shot miracle cure" that can be given after a patient has relapsed. Most of the patients that are cured of blood cancer are cured by their initial therapy. If virotherapy has a future in being of value to myeloma patients it will likely be in combination with other effective therapies and used early in disease course.
Boris - I first want to echo Multibilly's comments about the great job you do here at the Beacon. It is great that you followed up on this story. You all are an unbelievable resource for the myeloma community.
Great post by Ian. When trying new, innovative approaches to treating cancer, investigators often run into problems. With a difficult to treat disease like myeloma it is doubtful there will be a "one shot miracle cure" that can be given after a patient has relapsed. Most of the patients that are cured of blood cancer are cured by their initial therapy. If virotherapy has a future in being of value to myeloma patients it will likely be in combination with other effective therapies and used early in disease course.
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Mark11
Re: Phase 2 of Mayo measles trial - informal initial results
Tib - Thank you for your perspective on the trial and Dan's participation in it. Everyone here, and in the broader myeloma community, is grateful to you and Dan for your having taken part in the study. (For those who wish to see Tib in the video Multibilly mentioned, she appears starting around the 11:18 mark.)
I know the road ahead for you (Tib) and Dan will not be easy. I wish you much strength, and I hope both of you are able to find the support and love you deserve at this point. If we here in the Beacon community can be of any assistance, please let us know.
I don't believe that anyone from our staff, or from among our patient and caregiver columnists, has ever written an article focused solely on the option of stopping treatment. It has been touched on, however, in some of our patient columns. I'm thinking, for example, of April Nelson's column from last November, "Letters From Cancerland: On Being Mortal."
There also have been several threads here in the forum on the final stages of myeloma, including practical steps that can be taken. Those can be difficult threads to read through, but they are there for when they're needed.
Mark - Thanks, as always, for your kind words about the work we're doing at The Beacon. It's difficult work, so it's nice to know it's appreciated.
Jim - Good point about the cyclophosphamide used in Phase 1 of the trial. The Mayo Proceedings article that describes Stacy Erholtz's treatment – and which is referenced at the beginning of the main forum thread for the Mayo virotherapy study – probably mentions whether or not she got cyclophosphamide in addition to the virus. We haven't had time yet to check.
I know the road ahead for you (Tib) and Dan will not be easy. I wish you much strength, and I hope both of you are able to find the support and love you deserve at this point. If we here in the Beacon community can be of any assistance, please let us know.
I don't believe that anyone from our staff, or from among our patient and caregiver columnists, has ever written an article focused solely on the option of stopping treatment. It has been touched on, however, in some of our patient columns. I'm thinking, for example, of April Nelson's column from last November, "Letters From Cancerland: On Being Mortal."
There also have been several threads here in the forum on the final stages of myeloma, including practical steps that can be taken. Those can be difficult threads to read through, but they are there for when they're needed.
Mark - Thanks, as always, for your kind words about the work we're doing at The Beacon. It's difficult work, so it's nice to know it's appreciated.
Jim - Good point about the cyclophosphamide used in Phase 1 of the trial. The Mayo Proceedings article that describes Stacy Erholtz's treatment – and which is referenced at the beginning of the main forum thread for the Mayo virotherapy study – probably mentions whether or not she got cyclophosphamide in addition to the virus. We haven't had time yet to check.
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Boris Simkovich - Name: Boris Simkovich
Founder
The Myeloma Beacon
Re: Phase 2 of Mayo measles trial - informal initial results
My impression is that virotherapy will be linked to tissue markers, as is PDL1 links for BRAF. Articles this week from VICE TV and NY Times exaggerate twice. Melanomas have always been susceptible to vaccines, which had sporadic results but didn't generalize. At MSKCC, all marrows are tested for BRAF.
Large positive for melanoma. My own myeloma is negative. It will come! We need a media break.
Robert Lewy MD FACP
Large positive for melanoma. My own myeloma is negative. It will come! We need a media break.
Robert Lewy MD FACP
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Kingseason
Re: Phase 2 of Mayo measles trial - informal initial results
Although disappointing, particularly for the participants (for whom we are all grateful), I think we might want to look at it from a basic research perspective which tells us it's not a failure but one step closer to the answer.
The proof of concept has been established with Stacy, at least, and with other forms of cancer.
I would not be surprised that within two to three years, perhaps sooner, vaccination therapy will be an effective part of the multiple myeloma armamentarium.
Keepin' the faith!
S.
The proof of concept has been established with Stacy, at least, and with other forms of cancer.
I would not be surprised that within two to three years, perhaps sooner, vaccination therapy will be an effective part of the multiple myeloma armamentarium.
Keepin' the faith!
S.
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Steve - Name: Steve
- Who do you know with myeloma?: myself
- When were you/they diagnosed?: December 2009
- Age at diagnosis: 55
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