This forum thread will be used by the Beacon Staff to post updates about the proceedings of the American Society of Hematology (ASH) meeting taking place on Day 2 (Sunday, December 11) of the conference.
Beacon forum participants are free, however, to use this thread to comment on the updates, post their own updates or thoughts, and ask questions. Everyone is encouraged to participate.
Feel free to also check out the threads dedicated to Day 1, Day 3, and Day 4 of the ASH 2011 meeting.
For an earlier discussion of ASH 2011 presentation and poster abstracts, please see this thread:
https://myelomabeacon.org/forum/ash-2011-annual-meeting-multiple-myeloma-t692.html
Forums
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
The second day here at the ASH 2011 meeting has been similar to the first day, in the sense that there really aren't that many myeloma-related oral presentations. Instead, most of the new research coming out is once again in the form of poster summaries.
Now, what we just said is not completely true. There were more oral presentations on myeloma research results today than there were yesterday. But there were just a few, and we'll be summarizing just one of them, and spending the rest of the time reviewing a number of the posters that have been up during the day for review.
Tomorrow, by the way, is the really big day in terms of myeloma-related oral presentations. They'll be going on almost all day, and we'll be covering almost all of them. So, be prepared to either check in regularly to keep up with all the results, or make sure to set aside time during the next week or two to review the news.
In any case ... Let's get to today's presentations. We're not going to group them as much as we did with yesterday's review of the day, so things may bounce around a bit.
Now, what we just said is not completely true. There were more oral presentations on myeloma research results today than there were yesterday. But there were just a few, and we'll be summarizing just one of them, and spending the rest of the time reviewing a number of the posters that have been up during the day for review.
Tomorrow, by the way, is the really big day in terms of myeloma-related oral presentations. They'll be going on almost all day, and we'll be covering almost all of them. So, be prepared to either check in regularly to keep up with all the results, or make sure to set aside time during the next week or two to review the news.
In any case ... Let's get to today's presentations. We're not going to group them as much as we did with yesterday's review of the day, so things may bounce around a bit.
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
Some of the regular Beacon readers may have heard about the so-called "BiRD" treatment regimen for newly diagnosed myeloma patients. It is a combination of the antibiotic clarithromycin (Biaxin), Revlimid, and dexamethasone.
Well, in addition to "BiRD", we now have "T-BiRD" ... basically the BiRD regimen with thalidomide added to it.
Like the BiRD regimen, T-BiRD consists completely of medications that can be taken at home as capsules or pills. No injected medications are part of the treatment.
Researchers from the Weill Cornell Medical College and New York-Presbyterian Hospital conducted a small trial with 26 newly diagnosed myeloma patients to test the efficacy and safety of the T-BiRD regimen.
All 26 patients had either Stage II or Stage III according to the Durie-Salmon criteria. The overall response rate to the treatment was 77 percent -- 4 percent had a complete response, 31 percent had a very good partial response, and 42 percent had a partial response.
18 of the 26 patients underwent a stem cell transplant in addition to the T-BiRD regimen There were no issues among those patients with collecting sufficient stem cells for transplantation.
Overall survival after about a four-year follow-up is 84.5 percent. Some survival measures indicate the therapy is comparably effective in patients with standard and higher-risk genetic characteristics. However, these does appear to be a trend to greater overall survival in standard risk patients.
Patients appear to respond quickly to the regimen. However, side effects were an issue for some patients ... 8 of the 26 patients halted treatment with the regimen due to the level of side effects.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper40976.html
Well, in addition to "BiRD", we now have "T-BiRD" ... basically the BiRD regimen with thalidomide added to it.
Like the BiRD regimen, T-BiRD consists completely of medications that can be taken at home as capsules or pills. No injected medications are part of the treatment.
Researchers from the Weill Cornell Medical College and New York-Presbyterian Hospital conducted a small trial with 26 newly diagnosed myeloma patients to test the efficacy and safety of the T-BiRD regimen.
All 26 patients had either Stage II or Stage III according to the Durie-Salmon criteria. The overall response rate to the treatment was 77 percent -- 4 percent had a complete response, 31 percent had a very good partial response, and 42 percent had a partial response.
18 of the 26 patients underwent a stem cell transplant in addition to the T-BiRD regimen There were no issues among those patients with collecting sufficient stem cells for transplantation.
Overall survival after about a four-year follow-up is 84.5 percent. Some survival measures indicate the therapy is comparably effective in patients with standard and higher-risk genetic characteristics. However, these does appear to be a trend to greater overall survival in standard risk patients.
Patients appear to respond quickly to the regimen. However, side effects were an issue for some patients ... 8 of the 26 patients halted treatment with the regimen due to the level of side effects.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper40976.html
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
There was an oral presentation in the early evening on Sunday that looked at the extent to which "molecular remission" affects the length of a myeloma patient's survival.
The presentation was by Dr. Nicholas Kroeger from the University Medical Center in Hamburg, Germany. The title of his presentation was:
"Achievement of Sustained Molecular Remission Induces Long-Term Freedom From Disease After Autologous-Allogeneic Tandem Transplantation in Patients with Multiple Myeloma."
The title may make it seem like the presentation is about tandem auto-allo transplants. But really, as I first mentioned, the topic of the presentation was about the impact on survival of patients achieving a molecular remission.
What's a molecular remission? It's a more stringent form of complete response, where a more sensitive test is used to determine whether there is still evidence of myeloma in a patient's bone marrow. Different types of molecular remission are often defined, as well, based on whether repeated tests performed over various periods of time consistently come up with no sign of disease in the patient.
The patients in Dr. Kroeger's study were treated during the period from 2000 to 2008. They had either Stage 2 or Stage 3 multiple myeloma. Due to the time period when the study was conducted, patients were treated upfront with older treatment regimens rather than regimens involving novel myeloma drugs.
The study included 73 patients; median patient age was 50 years (patients had to be between the ages of 18 and 65 to take part in the trial). After induction therapy, patients received high-dose melphalan and then an auto transplant.
Then, after 2-3 months, the patients went through another conditioning regimen involving melphalan, fludarabine, and ATG followed by an allogeneic (donor) stem cell transplant.
Overall, 44 patients (60 %) achieved a complete response (CR). 8 % achieved a VGPR and 18 % a partial remission.
Molecular remission was observed in 30 patients, or 46 percent of the patient sample.
Of those 30 patients, 15 had a "sustained" molecular remission, meaning that repeated tests showed no evidence of myeloma. The other 15 had only intermittent remission.
After a median follow-up of 7 years, the 5-year progression-free survival was 29 percent.
Patients with sustained negative molecular remission had a 5 year PFS of 85 percent vs. 31 percent for mixed molecular remission.
The 5-year overall survival was 52 percent.
And here is the key result:
Patients who achieved a sustained molecular remission had a 5 year overall survival of 91 percent, while those with mixed molecular remission resulted in a 5 year overall survival of 87 percent.
In other words, achieving molecular remission, whether sustained or mixed, has a significant impact on overall survival.
And this is one of the two key takeaways Dr. Kroeger said that he wanted people to take away from the presentation.
He said that it isn't important how or when a patient achieves molecular remission. If a patient is able to achieve molecular remission after their induction therapy, he doubts there's anything to be gained by doing anything further with the patient at that time.
If molecular remission is achieved after induction plus conditioning and an auto transplant, then an allo transplant isn't necessary in Dr. Kroeger's eyes.
But the key is to get patients to a molecular remission if at all possible.
The other key takeaway from this trial, in Dr. Kroeger's eyes, wasn't fully explored in either the abstract for the presentation or the presentation itself. But it's the fact that donor lymphocyte infusions (DLIs) make a very important contribution to improving the efficacy of allo transplants.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper42900.html
For more on donor lymphocyte infusions in myeloma patients who have received an allo transplant, see this discussion here in the Beacon's forum:
https://myelomabeacon.org/forum/donor-lymphocyte-infusions-dli-for-multiple-myeloma-t744.html
The presentation was by Dr. Nicholas Kroeger from the University Medical Center in Hamburg, Germany. The title of his presentation was:
"Achievement of Sustained Molecular Remission Induces Long-Term Freedom From Disease After Autologous-Allogeneic Tandem Transplantation in Patients with Multiple Myeloma."
The title may make it seem like the presentation is about tandem auto-allo transplants. But really, as I first mentioned, the topic of the presentation was about the impact on survival of patients achieving a molecular remission.
What's a molecular remission? It's a more stringent form of complete response, where a more sensitive test is used to determine whether there is still evidence of myeloma in a patient's bone marrow. Different types of molecular remission are often defined, as well, based on whether repeated tests performed over various periods of time consistently come up with no sign of disease in the patient.
The patients in Dr. Kroeger's study were treated during the period from 2000 to 2008. They had either Stage 2 or Stage 3 multiple myeloma. Due to the time period when the study was conducted, patients were treated upfront with older treatment regimens rather than regimens involving novel myeloma drugs.
The study included 73 patients; median patient age was 50 years (patients had to be between the ages of 18 and 65 to take part in the trial). After induction therapy, patients received high-dose melphalan and then an auto transplant.
Then, after 2-3 months, the patients went through another conditioning regimen involving melphalan, fludarabine, and ATG followed by an allogeneic (donor) stem cell transplant.
Overall, 44 patients (60 %) achieved a complete response (CR). 8 % achieved a VGPR and 18 % a partial remission.
Molecular remission was observed in 30 patients, or 46 percent of the patient sample.
Of those 30 patients, 15 had a "sustained" molecular remission, meaning that repeated tests showed no evidence of myeloma. The other 15 had only intermittent remission.
After a median follow-up of 7 years, the 5-year progression-free survival was 29 percent.
Patients with sustained negative molecular remission had a 5 year PFS of 85 percent vs. 31 percent for mixed molecular remission.
The 5-year overall survival was 52 percent.
And here is the key result:
Patients who achieved a sustained molecular remission had a 5 year overall survival of 91 percent, while those with mixed molecular remission resulted in a 5 year overall survival of 87 percent.
In other words, achieving molecular remission, whether sustained or mixed, has a significant impact on overall survival.
And this is one of the two key takeaways Dr. Kroeger said that he wanted people to take away from the presentation.
He said that it isn't important how or when a patient achieves molecular remission. If a patient is able to achieve molecular remission after their induction therapy, he doubts there's anything to be gained by doing anything further with the patient at that time.
If molecular remission is achieved after induction plus conditioning and an auto transplant, then an allo transplant isn't necessary in Dr. Kroeger's eyes.
But the key is to get patients to a molecular remission if at all possible.
The other key takeaway from this trial, in Dr. Kroeger's eyes, wasn't fully explored in either the abstract for the presentation or the presentation itself. But it's the fact that donor lymphocyte infusions (DLIs) make a very important contribution to improving the efficacy of allo transplants.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper42900.html
For more on donor lymphocyte infusions in myeloma patients who have received an allo transplant, see this discussion here in the Beacon's forum:
https://myelomabeacon.org/forum/donor-lymphocyte-infusions-dli-for-multiple-myeloma-t744.html
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
A topic that was the focus of both a poster presentation and an oral presentation on Sunday was the protein called "cereblon."
Cereblon is naturally produced by humans and present in the human body to differing degrees in different people.
Several years ago, research was published that suggested that the interaction between thalidomide and cereblon is what led to the drug causing birth defects when it was first used in the 1950s and 1960s by pregnant women.
This finding led to a flurry of research into the role of cereblon when thalidomide and drugs related to it (Revlimid and pomalidomide) are used to treat myeloma.
Some of the initial results of that research came out during today's sessions at ASH.
In particular, researchers from the Mayo Clinic presented laboratory data during an oral presentation that suggest that cereblon plays a key role in whether or not myeloma patients respond to treatment with Revlimid or pomalidomide.
Researchers from the University of Vienna in Austria presented similar data showing that the amount of cereblon a myeloma patient has in their bone marrow is strongly related to how well the patient responds to treatment with Revlimid and dexamethasone.
Together, these studies suggest that, in the future, physicians may check a myeloma patient's cereblon levels to help determine whether or not the patient should be treated with thalidomide, Revlimid, or (if it is approved by regulatory authorities) pomalidomide.
The abstract for the research by the Mayo researchers is titled "Cereblon Expression Is Required for the Anti-Myeloma Activity of Lenalidomide and pomalidomide"; Abstract:: http://ash.confex.com/ash/2011/webprogram/Paper41481.html
The abstract for the research by the University of Vienna researchers is titled "High Expression of the Thalidomide-Binding Protein Cereblon (CRBN) Is Associated with Improved Clinical Response in Patients with Multiple Myeloma Treated with Lenalidomide and Dexamethasone", Abstract: http://ash.confex.com/ash/2011/webprogram/Paper40140.html
There also will be a poster presented on Monday by researchers from the U.S. pharmaceutical company Celgene that also is related to this issue. The poster is titled "Direct Binding with Cereblon Mediates the Antiproliferative and Immunomodulatory Action of Lenalidomide and pomalidomide," and the abstract is: http://ash.confex.com/ash/2011/webprogram/Paper41430.html
(Celgene is the company that markets thalidomide and Revlimid and is developing pomalidomide as a potential treatment for myeloma).
Cereblon is naturally produced by humans and present in the human body to differing degrees in different people.
Several years ago, research was published that suggested that the interaction between thalidomide and cereblon is what led to the drug causing birth defects when it was first used in the 1950s and 1960s by pregnant women.
This finding led to a flurry of research into the role of cereblon when thalidomide and drugs related to it (Revlimid and pomalidomide) are used to treat myeloma.
Some of the initial results of that research came out during today's sessions at ASH.
In particular, researchers from the Mayo Clinic presented laboratory data during an oral presentation that suggest that cereblon plays a key role in whether or not myeloma patients respond to treatment with Revlimid or pomalidomide.
Researchers from the University of Vienna in Austria presented similar data showing that the amount of cereblon a myeloma patient has in their bone marrow is strongly related to how well the patient responds to treatment with Revlimid and dexamethasone.
Together, these studies suggest that, in the future, physicians may check a myeloma patient's cereblon levels to help determine whether or not the patient should be treated with thalidomide, Revlimid, or (if it is approved by regulatory authorities) pomalidomide.
The abstract for the research by the Mayo researchers is titled "Cereblon Expression Is Required for the Anti-Myeloma Activity of Lenalidomide and pomalidomide"; Abstract:: http://ash.confex.com/ash/2011/webprogram/Paper41481.html
The abstract for the research by the University of Vienna researchers is titled "High Expression of the Thalidomide-Binding Protein Cereblon (CRBN) Is Associated with Improved Clinical Response in Patients with Multiple Myeloma Treated with Lenalidomide and Dexamethasone", Abstract: http://ash.confex.com/ash/2011/webprogram/Paper40140.html
There also will be a poster presented on Monday by researchers from the U.S. pharmaceutical company Celgene that also is related to this issue. The poster is titled "Direct Binding with Cereblon Mediates the Antiproliferative and Immunomodulatory Action of Lenalidomide and pomalidomide," and the abstract is: http://ash.confex.com/ash/2011/webprogram/Paper41430.html
(Celgene is the company that markets thalidomide and Revlimid and is developing pomalidomide as a potential treatment for myeloma).
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
Many Beacon readers are younger than your average myeloma patient, so there may be interest here in the forum in a poster presentation on Sunday that summarized research by myeloma specialists at the Mayo Clinic.
The researchers reviewed the records of all myeloma patients treated at the Mayo Clinic from 1999 to 2008 and looked specifically for younger myeloma patients, defined as being 45 years of age or less at the age of diagnosis.
In the end, the researchers identified 100 patients that fell into this age group.
Because the patient sample went back to 1999 and stopped at 2008, not all the patients in the sample received initial therapy with the newer, novel myeloma therapies (thalidomide, Velcade, or Revlimid). In fact, only 45 percent of the patients were treated with induction regimens involving a novel agent.
A full 85 percent of the 100 patients received an autologous stem cell transplant at some point, and 15 percent of the patients underwent an allogeneic (donor) stem cell transplant after an initial auto transplant.
The median follow-up of patients in the sample was 86 months, and, during the time of follow-up, individual patients underwent treatment with a median of 5 different treatment regimens. (At least one patient was treated with a total of 14 different regimens!)
The median overall survival of the patients in the sample was 93 months (7.75 years). In comparison, myeloma patients treated at Mayo during the same period of time, but were older than 45 years of age at the time of diagnosis, had a median overall survival of 53 months (4.42 years).
Also, among the patients who were 45 years or younger at the time of diagnosis, the overall survival rates at 5 and 7 years were 69% and 59%, respectively.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper44812.html
The researchers reviewed the records of all myeloma patients treated at the Mayo Clinic from 1999 to 2008 and looked specifically for younger myeloma patients, defined as being 45 years of age or less at the age of diagnosis.
In the end, the researchers identified 100 patients that fell into this age group.
Because the patient sample went back to 1999 and stopped at 2008, not all the patients in the sample received initial therapy with the newer, novel myeloma therapies (thalidomide, Velcade, or Revlimid). In fact, only 45 percent of the patients were treated with induction regimens involving a novel agent.
A full 85 percent of the 100 patients received an autologous stem cell transplant at some point, and 15 percent of the patients underwent an allogeneic (donor) stem cell transplant after an initial auto transplant.
The median follow-up of patients in the sample was 86 months, and, during the time of follow-up, individual patients underwent treatment with a median of 5 different treatment regimens. (At least one patient was treated with a total of 14 different regimens!)
The median overall survival of the patients in the sample was 93 months (7.75 years). In comparison, myeloma patients treated at Mayo during the same period of time, but were older than 45 years of age at the time of diagnosis, had a median overall survival of 53 months (4.42 years).
Also, among the patients who were 45 years or younger at the time of diagnosis, the overall survival rates at 5 and 7 years were 69% and 59%, respectively.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper44812.html
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
There was more data presented on Sunday about the potential new myeloma treatment ARRY-520.
We also looked at this drug in the review of Day 1 events at ASH 2011 here in the forum, in this posting:
https://myelomabeacon.org/forum/ash-2011-multiple-myeloma-discussion-day-1-t758.html#p3254
The data in Saturday's poster session was from the Phase 1 trial of ARRY-520. The data from the Sunday poster was from a Phase 2 trial of the drug.
The phase 2 trial involved 32 patients who had relapsed myeloma and a median of five previous treatment regimens. The previous regimens were required to include Velcade and at least one "imid" (either thalidomide or Revlimid).
Four of the 32 patients (12.5 percent) achieved a partial response and another 2 patients achieved a minimal response. The median time to response was on the order of 4 months.
Patients were infused with ARRY-520 on days 1 and 2 of a two-week cycle, and they also received GCSF (Neupogen or Neulasta) to help sustain white blood cell counts during the therapy.
The researchers who presented their poster summary conclude that ARRY-520 "shows promising evidence of single-agent clinical activity and an acceptable safety profile in heavily pretreated patients."
Yet the side effect profile of the drug does seem like it may raise some concerns, with upwards of a quarter of the patients treated with the drug experiencing serious (grade 3 or 4) side effects such as low white blood cell counts and low platelet counts.
The company developing the drug, Array BioPharma, plans to continue testing the drug in different combinations -- with dexamethasone, with carfilzomib, and with Velcade and dexamethasone -- in relapsed myeloma patients.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper40171.html
We also looked at this drug in the review of Day 1 events at ASH 2011 here in the forum, in this posting:
https://myelomabeacon.org/forum/ash-2011-multiple-myeloma-discussion-day-1-t758.html#p3254
The data in Saturday's poster session was from the Phase 1 trial of ARRY-520. The data from the Sunday poster was from a Phase 2 trial of the drug.
The phase 2 trial involved 32 patients who had relapsed myeloma and a median of five previous treatment regimens. The previous regimens were required to include Velcade and at least one "imid" (either thalidomide or Revlimid).
Four of the 32 patients (12.5 percent) achieved a partial response and another 2 patients achieved a minimal response. The median time to response was on the order of 4 months.
Patients were infused with ARRY-520 on days 1 and 2 of a two-week cycle, and they also received GCSF (Neupogen or Neulasta) to help sustain white blood cell counts during the therapy.
The researchers who presented their poster summary conclude that ARRY-520 "shows promising evidence of single-agent clinical activity and an acceptable safety profile in heavily pretreated patients."
Yet the side effect profile of the drug does seem like it may raise some concerns, with upwards of a quarter of the patients treated with the drug experiencing serious (grade 3 or 4) side effects such as low white blood cell counts and low platelet counts.
The company developing the drug, Array BioPharma, plans to continue testing the drug in different combinations -- with dexamethasone, with carfilzomib, and with Velcade and dexamethasone -- in relapsed myeloma patients.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper40171.html
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
Data also were presented in a poster Sunday looking at the potential new drug pomalidomide.
As was mentioned earlier, pomalidomide is a "chemical cousin" of thalidomide and Revlimid.
Researchers from the Mayo Clinic examined data from a study they have been doing into the efficacy and safety of pomalidomide treatment in combination with dexamethasone. The study has been ongoing now for over four years, so the researchers can look at the long-term impact of treatment with the drug combination.
All patients in the study had been previously treated with other anti-myeloma drugs. When patients entered the study, their median time since first diagnosis was about 3.8 years. The abstract or poster did not provide, however, what the median number of previous therapies was that patients had.
Patients had a median age of 65 and about three quarters of the patients had Stage 2 or Stage 3 based on ISS criteria.
The overall response to treatment ws 65 percent, including 7 percent stringent complete response, 7 percent complete response, 25 percent very good partial response, and 27 percent partial response.
Time to response was rather rapid -- 1.7 months. And the median duration of response was about 21.3 months.
91 percent of the patients in the study were still alive 1 year after entering the trial, and 76 percent were still alive 2 years after they entered the trial. Median overall survival has not yet been reached after a median follow up of about 34 months.
The treatment regimen does seem to have a different impact on patients with high-risk disease than it does on patients with standard-risk disease. That is, standard-risk patients do appear to perform better on the combination treatment than higher-risk patients.
The researchers concluded that the treatment is "highly effective" and "well-tolerated."
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper41394.html
Pomalidomide-related news articles here at The Beacon:
https://myelomabeacon.org/tag/pomalidomide/
As was mentioned earlier, pomalidomide is a "chemical cousin" of thalidomide and Revlimid.
Researchers from the Mayo Clinic examined data from a study they have been doing into the efficacy and safety of pomalidomide treatment in combination with dexamethasone. The study has been ongoing now for over four years, so the researchers can look at the long-term impact of treatment with the drug combination.
All patients in the study had been previously treated with other anti-myeloma drugs. When patients entered the study, their median time since first diagnosis was about 3.8 years. The abstract or poster did not provide, however, what the median number of previous therapies was that patients had.
Patients had a median age of 65 and about three quarters of the patients had Stage 2 or Stage 3 based on ISS criteria.
The overall response to treatment ws 65 percent, including 7 percent stringent complete response, 7 percent complete response, 25 percent very good partial response, and 27 percent partial response.
Time to response was rather rapid -- 1.7 months. And the median duration of response was about 21.3 months.
91 percent of the patients in the study were still alive 1 year after entering the trial, and 76 percent were still alive 2 years after they entered the trial. Median overall survival has not yet been reached after a median follow up of about 34 months.
The treatment regimen does seem to have a different impact on patients with high-risk disease than it does on patients with standard-risk disease. That is, standard-risk patients do appear to perform better on the combination treatment than higher-risk patients.
The researchers concluded that the treatment is "highly effective" and "well-tolerated."
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper41394.html
Pomalidomide-related news articles here at The Beacon:
https://myelomabeacon.org/tag/pomalidomide/
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
It is not often that one sees results for a trial into a myeloma vaccine, but there was a poster on Sunday that looked at trial outcomes for such a vaccine.
Unfortunately, the results were not particularly positive, although the researchers who conducted the study believe the vaccine warrants further investigation.
The vaccine that was tested was is known as L-BLP25, or Stimuvax, and it is being investigated as a potential treatment for a number of different cancers.
Researchers in Sweden investigated the vaccine in 34 patients who were a mix of previously untreated smoldering myeloma patients as well as patients with active, Stage 2 or 3, multiple myeloma.
None of the patients during the trial, however, showed a response to the vaccine treatment.
The vaccine did show some signs of slowly reducing m-protein levels over time in the trial participants, which is partly why the researchers who conducted the study believe the drug is still worth looking at as a potential treatment for multiple myeloma.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper37794.html
Unfortunately, the results were not particularly positive, although the researchers who conducted the study believe the vaccine warrants further investigation.
The vaccine that was tested was is known as L-BLP25, or Stimuvax, and it is being investigated as a potential treatment for a number of different cancers.
Researchers in Sweden investigated the vaccine in 34 patients who were a mix of previously untreated smoldering myeloma patients as well as patients with active, Stage 2 or 3, multiple myeloma.
None of the patients during the trial, however, showed a response to the vaccine treatment.
The vaccine did show some signs of slowly reducing m-protein levels over time in the trial participants, which is partly why the researchers who conducted the study believe the drug is still worth looking at as a potential treatment for multiple myeloma.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper37794.html
Re: ASH 2011 Multiple Myeloma Discussion - Day 2
Secondary cancer has been an important topic this year within the myeloma community, with most of the attention focused on the possibility that Revlimid may increase a patient's risk of developing a cancer in addition to myeloma.
(For the Beacon's news articles on this topic, see: https://myelomabeacon.org/tag/secondary-cancer/ .)
At Sunday's ASH sessions, however, a poster summary was presented of research looking at whether there is any link between Velcade treatment and a higher incidence of secondary cancer.
The conclusion? Well, it depends a bit on how you look at the data.
The researchers who conducted the study summarized their findings by saying that Velcade "does not appear to be associated with an increased risk of either hematologic or solid tumor [secondary cancer]".
Yet the data in the poster do suggest a trend toward Velcade increasing the incidence of secondary cancers.
The poster examines data from four trials that were carried out to test the efficacy and safety of Velcade. Only three of those trials, however, had separate arms of the trial that had a Velcade-based therapy being used in one group of patients and no Velcade used in the other group of patients. (One study had two arms, one with Velcade therapy alone, and one with Velcade plus Doxil.)
Furthermore, one of the three trials with Velcade and "no Velcade" patient groups had thalidomide maintenance therapy in the "no Velcade" arm of the trial, and thalidomide -- like Revlimid -- has been suspected of increasing the risk of secondary cancer.
So, in reality, only two of the four trials provide a strong basis for answering the question: Does Velcade increase the risk of secondary cancer.
And the results for those two trials are as follows.
In the APEX trial of Velcade in relapsed/refractory myeloma patients, Velcade-treated patients had a rate of secondary cancers of 0.88 cases for every 100 patient years. In contrast, patients in the same trial who were treated only with dexamethasone had no cases of secondary cancer whatsoever.
Similarly, in the VISTA trial in newly diagnosed myeloma patients which compared Velcade+melphalan+prednisone (VMP) as intial therapy versus just melphalan+predisone (MP), there were 1.66 cases of secondary cancer for every 100 patient years of treatment in the VMP arm of the trial, and versus 1.30 in the MP only arm of the trial.
So in the two trials that really can speak directly to the question: Does treatment with Velcade increase the risk of secondary cancer, the Velcade-treated patients had higher rates of secondary cancer than the patients who were not treated with Velcade.
All that having been said, the researchers who conducted this study make a valid point when they note that the rate of secondary cancers observed in the Velcade-treated patients in these studies is similar (or lower) than the rate of cancer in the general U.S. population similar in age to myeloma patients.
Also, it is worth noting that the European Medicines Agency, when it conducted its review of Revlimid and its potential link to secondary cancers, found "that there were 3.98 cases of new cancer for every 100 patient-years in patients receiving Revlimid compared with 1.38 cases in those not receiving Revlimid."
So the secondary cancer rates for Velcade found in the research summarized in yesterday's poster are substantially lower than those which have been discussed for Revlimid.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper39543.html
Velcade-related news articles here at The Beacon: https://myelomabeacon.org/tag/Velcade/
(For the Beacon's news articles on this topic, see: https://myelomabeacon.org/tag/secondary-cancer/ .)
At Sunday's ASH sessions, however, a poster summary was presented of research looking at whether there is any link between Velcade treatment and a higher incidence of secondary cancer.
The conclusion? Well, it depends a bit on how you look at the data.
The researchers who conducted the study summarized their findings by saying that Velcade "does not appear to be associated with an increased risk of either hematologic or solid tumor [secondary cancer]".
Yet the data in the poster do suggest a trend toward Velcade increasing the incidence of secondary cancers.
The poster examines data from four trials that were carried out to test the efficacy and safety of Velcade. Only three of those trials, however, had separate arms of the trial that had a Velcade-based therapy being used in one group of patients and no Velcade used in the other group of patients. (One study had two arms, one with Velcade therapy alone, and one with Velcade plus Doxil.)
Furthermore, one of the three trials with Velcade and "no Velcade" patient groups had thalidomide maintenance therapy in the "no Velcade" arm of the trial, and thalidomide -- like Revlimid -- has been suspected of increasing the risk of secondary cancer.
So, in reality, only two of the four trials provide a strong basis for answering the question: Does Velcade increase the risk of secondary cancer.
And the results for those two trials are as follows.
In the APEX trial of Velcade in relapsed/refractory myeloma patients, Velcade-treated patients had a rate of secondary cancers of 0.88 cases for every 100 patient years. In contrast, patients in the same trial who were treated only with dexamethasone had no cases of secondary cancer whatsoever.
Similarly, in the VISTA trial in newly diagnosed myeloma patients which compared Velcade+melphalan+prednisone (VMP) as intial therapy versus just melphalan+predisone (MP), there were 1.66 cases of secondary cancer for every 100 patient years of treatment in the VMP arm of the trial, and versus 1.30 in the MP only arm of the trial.
So in the two trials that really can speak directly to the question: Does treatment with Velcade increase the risk of secondary cancer, the Velcade-treated patients had higher rates of secondary cancer than the patients who were not treated with Velcade.
All that having been said, the researchers who conducted this study make a valid point when they note that the rate of secondary cancers observed in the Velcade-treated patients in these studies is similar (or lower) than the rate of cancer in the general U.S. population similar in age to myeloma patients.
Also, it is worth noting that the European Medicines Agency, when it conducted its review of Revlimid and its potential link to secondary cancers, found "that there were 3.98 cases of new cancer for every 100 patient-years in patients receiving Revlimid compared with 1.38 cases in those not receiving Revlimid."
So the secondary cancer rates for Velcade found in the research summarized in yesterday's poster are substantially lower than those which have been discussed for Revlimid.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper39543.html
Velcade-related news articles here at The Beacon: https://myelomabeacon.org/tag/Velcade/
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