It's hard to say if this happened on purpose, but it's probably not a coincidence that Dr. San Miguel's presentation was followed by a presentation by Dr. Maria-Victoria Mateos, who is one of Dr. San Miguel's colleagues at the University Hospital in Salamanca.
Dr. Mateos presented results of a Spanish trial that started in 2005 and was conducted with older, newly diagnosed multiple myeloma patients who were ineligible to receive a stem cell transplant.
Patients in this study first received induction (upfront) therapy with either Velcade, melphalan, and prednisone (VMP) or Velcade, thalidomide, and prednisone (VMP). The patients were randomly assigned to one of those two options.
After patients completed their induction therapy, they once again were randomly assigned to a maintenance treatment. There were two possible maintenance regimens: Velcade plus thalidomide (VT) or Velcade plus prednison (VP).
A total of 178 patients started one of those two maintenance therapies.
In previously published research, Dr. Mateos and her colleagues showed that the two induction treatments tested in this trial provided very similar efficacy.
In this presentation, Dr. Mateos focused on comparing the results of the maintenance therapies tested in the trial.
After a median follow-up of 34 months, results showed that maintenance therapy increased the complete response rate from 24 percent that patients had after their induction therapy was complete, to 42 percent.
The complete response rate was slightly higher for VT versus VP (46 percent versus 39 percent), but the researchers stated that the difference was not large enough to be statistically significant.
For all patients receiving maintenance therapy, the median progression free survival from the start of treatment was 35 months and the median overall survival was 60 months.
Dr. Mateos noted that the length of the progression free survival experienced by the patients in this trial is one of the longest progression free survivals ever demonstrated for the kind of patients included in this trial (older, newly diagnosed patients ineligible for a stem cell transplant)
From the start of maintenance therapy, the median progression free survival was 30 months for patients receiving VT and 24 months for patients receiving VP.
There was no statistically significant difference, however, in overall survival between the two maintenance treatments.
The VT maintenance regimen had slightly higher levels of side effects, which, however, were generally not an issue between the two maintenance regimens.
Dr. Mateos believes that the benefit in terms of progression free survival seen for the VT regimen speaks in favor of pursuing that combination as a preferred maintenance regimen.
However, she also believes the regimen could be improved further if -- especially (but not solely) in terms of its side effect profile -- if patients were put on a Velcade-Revlimid maintenance regimen. That is, if the thalidomide in the VT regimen were replaced with Revlimid.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper39307.html
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Re: ASH 2011 Multiple Myeloma Discussion - Day 3
It also is probably not a coincidence that the next presentation also was about Velcade-based treatment regimens.
In particular, Dr. Ruben Niesvizky from the Weill Cornell Medical College in New York presented results from a Phase 3 involving older, newly diagnosed, transplant-ineligible multiple myeloma patients.
The 502 patients in the study received 24 weeks of induction therapy with one of three induction treatments: Velcade plus dexamethasone (VD), Velcade plus thalidomide and dexamethasone (VTD), and Velcade plus melphalan and prednisone (VMP).
All three regimens were followed by an extended 25-week Velcade consolidation therapy, with Velcade administered in five, five-week cycles with the drug administered weekly in the first four weeks each five week cycle.
(Dr. Niesvizky called the extended consolidation therapy "maintenance" therapy, but this is somewhat misleading, as it was not intended to last until a patient's disease progresses, as usually is the case with maintenance therapy.)
The patients in this study had median ages of 74, 73, and 72 for the VD, VTD, and VMP groups, respectively.
The three Velcade-based induction regimens were effective, with overall response rates of 73 percent, 80 percent, and 69 percent for VD, VTD, and VMP, respectively.
After a median follow-up of 22 months, the median progression free survival was 13.8 months for VD, 14.7 months for VTD, and 17.3 months for VMP. However, these differences were not statistically significant, and a close look at the progression free survival graph of the three regimens doesn't really show one regimen dominating the others in this regard.
Overall survival at one-year after treatment start was 87.4% (VD), 86.1% (VTD), and 88.9% (VMP), and, once again, there is no statistically significant difference in these results.
Patients taking the VTD experienced the most side effects while those taking just VD had the least side effects. The difference in side effects between the groups were not particularly noteworthy, however, and the most important side effects occurred during the induction therapy.
Overall, Dr. Niesvizky concluded that the three regimens were relatively similar in efficacy but yielded encouraging results for the patient population targeted by the trial.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper37808.html
In particular, Dr. Ruben Niesvizky from the Weill Cornell Medical College in New York presented results from a Phase 3 involving older, newly diagnosed, transplant-ineligible multiple myeloma patients.
The 502 patients in the study received 24 weeks of induction therapy with one of three induction treatments: Velcade plus dexamethasone (VD), Velcade plus thalidomide and dexamethasone (VTD), and Velcade plus melphalan and prednisone (VMP).
All three regimens were followed by an extended 25-week Velcade consolidation therapy, with Velcade administered in five, five-week cycles with the drug administered weekly in the first four weeks each five week cycle.
(Dr. Niesvizky called the extended consolidation therapy "maintenance" therapy, but this is somewhat misleading, as it was not intended to last until a patient's disease progresses, as usually is the case with maintenance therapy.)
The patients in this study had median ages of 74, 73, and 72 for the VD, VTD, and VMP groups, respectively.
The three Velcade-based induction regimens were effective, with overall response rates of 73 percent, 80 percent, and 69 percent for VD, VTD, and VMP, respectively.
After a median follow-up of 22 months, the median progression free survival was 13.8 months for VD, 14.7 months for VTD, and 17.3 months for VMP. However, these differences were not statistically significant, and a close look at the progression free survival graph of the three regimens doesn't really show one regimen dominating the others in this regard.
Overall survival at one-year after treatment start was 87.4% (VD), 86.1% (VTD), and 88.9% (VMP), and, once again, there is no statistically significant difference in these results.
Patients taking the VTD experienced the most side effects while those taking just VD had the least side effects. The difference in side effects between the groups were not particularly noteworthy, however, and the most important side effects occurred during the induction therapy.
Overall, Dr. Niesvizky concluded that the three regimens were relatively similar in efficacy but yielded encouraging results for the patient population targeted by the trial.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper37808.html
Re: ASH 2011 Multiple Myeloma Discussion - Day 3
Dr. Jesus Berdeja, from the Sarah Cannon Research Institute in Nashville, Tennessee, gave the day's second presentation about MLN9708, the orally-administered drug that is in the same class of drugs as Velcade and carfilzomib (proteasome inhibitors).
The presentation earlier in the day about MLN9708 looked at its dosing, safety, and efficacy when used by itself (i.e, as a "single agent") to treat relapsed and refractory myeloma patients.
Dr. Berdeja's presentation looked at results of a Phase 1/2 trial looking at MLN9708 combined with Revlimid and dexamethasone.
Furthermore, this trial is with patients who have not been previously treated -- that is, in most cases, they are newly diagnosed myeloma patients.
Thus far, the study has enrolled only 10 patients, so the results are relatively limited. The median patient age is 66 years old. The core objective of the study is to better understand the best dosing of weekly-administered MLN9708, but it also is intended to shed more light on the efficacy and safety of the drug.
Patients in the trial are receiving MLN9708 weekly on days 1, 8, and 15 of a 28-day cycle.
They also are receiving 25 mg Revlimid daily on days 1 through 21; and 40 mg dexamethasone on days 1, 8, 15, and 22.
Patients in the trial will be eligible to receive up to 12 cycles of treatment.
Trial participants wishing to undergo a stem cell transplant will do so after the first six cycles of treatment, and will then receive an additional six cycles of treatment after the stem cell transplant.
The median number of completed cycles to date for all patients is three, and six patients are still on treatment.
Results so far show that all nine patients with response data have achieved a partial response or better, including one complete response and three very good partial responses.
In addition, all patients achieved a 50 percent or greater decrease in M-protein by the end of the first cycle, and reached best response by the end of the fourth cycle.
To date, no patients have progressed, and one patient with a very good partial response discontinued treatment to undergo a stem cell transplant.
The most common side effects were rash (40 percent of patients), vomiting (30 percent), fatigue (30 percent), diarrhea (20 percent), constipation (20 percent), and nausea (20 percent). One patient (10 percent) reported mild peripheral neuropathy. The only serious side effect attributed to the drug was fainting in one patient (10 percent).
According to Dr. Berdeja, MLN9708 in combination with Revlimid and dexamethasone appears to be generally well tolerated in previously untreated multiple myeloma patients.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper39737.html
MLN9708-related news articles here at The Beacon: https://myelomabeacon.org/tag/mln9708/
The presentation earlier in the day about MLN9708 looked at its dosing, safety, and efficacy when used by itself (i.e, as a "single agent") to treat relapsed and refractory myeloma patients.
Dr. Berdeja's presentation looked at results of a Phase 1/2 trial looking at MLN9708 combined with Revlimid and dexamethasone.
Furthermore, this trial is with patients who have not been previously treated -- that is, in most cases, they are newly diagnosed myeloma patients.
Thus far, the study has enrolled only 10 patients, so the results are relatively limited. The median patient age is 66 years old. The core objective of the study is to better understand the best dosing of weekly-administered MLN9708, but it also is intended to shed more light on the efficacy and safety of the drug.
Patients in the trial are receiving MLN9708 weekly on days 1, 8, and 15 of a 28-day cycle.
They also are receiving 25 mg Revlimid daily on days 1 through 21; and 40 mg dexamethasone on days 1, 8, 15, and 22.
Patients in the trial will be eligible to receive up to 12 cycles of treatment.
Trial participants wishing to undergo a stem cell transplant will do so after the first six cycles of treatment, and will then receive an additional six cycles of treatment after the stem cell transplant.
The median number of completed cycles to date for all patients is three, and six patients are still on treatment.
Results so far show that all nine patients with response data have achieved a partial response or better, including one complete response and three very good partial responses.
In addition, all patients achieved a 50 percent or greater decrease in M-protein by the end of the first cycle, and reached best response by the end of the fourth cycle.
To date, no patients have progressed, and one patient with a very good partial response discontinued treatment to undergo a stem cell transplant.
The most common side effects were rash (40 percent of patients), vomiting (30 percent), fatigue (30 percent), diarrhea (20 percent), constipation (20 percent), and nausea (20 percent). One patient (10 percent) reported mild peripheral neuropathy. The only serious side effect attributed to the drug was fainting in one patient (10 percent).
According to Dr. Berdeja, MLN9708 in combination with Revlimid and dexamethasone appears to be generally well tolerated in previously untreated multiple myeloma patients.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper39737.html
MLN9708-related news articles here at The Beacon: https://myelomabeacon.org/tag/mln9708/
Re: ASH 2011 Multiple Myeloma Discussion - Day 3
The last presentation in this session was given by Dr. David Siegel from the Hackensack University Medical Center.
Dr. Siegel presented results from a Phase 3 study of Zolinza (vorinostat). Zolinza, already approved for cutaneous T-cell lymphoma, is a histone deacetylase (HDAC) inhibitor, which are used in cancer treatment to increase the production of proteins that slow cell division, repair DNA mistakes, and control cell death. Researchers hope that this should help the body prevent cells from multiplying out of control and becoming cancerous.
The goal of this study was to determine the efficacy and safety of Zolinza in combination with Velcade in relapsed/refractory multiple myeloma patients.
The study included 143 patients who had received a median of 4 prior multiple myeloma therapies (100 percent had prior Velcade, 85 percent thalidomide (Thalomid), 71 percent Revlimid (lenalidomide), 4 percent pomalidomide, and 74 percent had received a stem cell transplant).
Patients received 400 mg/d Zolinza on days 1 to 14 of 21-day treatment cycles plus 1.3 mg/m2 Velcade on days 1, 4, 8, and 11. Patients with no change after four cycles of treatment or progressive disease after two cycles of treatment could additionally receive 20 mg dexamethasone on the day of and day after each dose of Velcade.
So far, 142 patients have been treated, with a median of four cycles. Efficacy data is not yet available.
Of the 142 patients, 17 percent have responded to treatment. Median overall survival is 11.2 months with a two-year overall survival rate of 32 percent.
the most common side effects were mostly blood and gastrointestinal problems; peripheral neuropathy was infrequent, with severe peripheral neuropathy occurring in 2 percent of patients.
According to Dr. Siegel, this combination may offer a new treatment option for heavily pretreated myeloma patients.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper37976.html
Zolinza-related news articles here at The Beacon: https://myelomabeacon.org/tag/zolinza/
Dr. Siegel presented results from a Phase 3 study of Zolinza (vorinostat). Zolinza, already approved for cutaneous T-cell lymphoma, is a histone deacetylase (HDAC) inhibitor, which are used in cancer treatment to increase the production of proteins that slow cell division, repair DNA mistakes, and control cell death. Researchers hope that this should help the body prevent cells from multiplying out of control and becoming cancerous.
The goal of this study was to determine the efficacy and safety of Zolinza in combination with Velcade in relapsed/refractory multiple myeloma patients.
The study included 143 patients who had received a median of 4 prior multiple myeloma therapies (100 percent had prior Velcade, 85 percent thalidomide (Thalomid), 71 percent Revlimid (lenalidomide), 4 percent pomalidomide, and 74 percent had received a stem cell transplant).
Patients received 400 mg/d Zolinza on days 1 to 14 of 21-day treatment cycles plus 1.3 mg/m2 Velcade on days 1, 4, 8, and 11. Patients with no change after four cycles of treatment or progressive disease after two cycles of treatment could additionally receive 20 mg dexamethasone on the day of and day after each dose of Velcade.
So far, 142 patients have been treated, with a median of four cycles. Efficacy data is not yet available.
Of the 142 patients, 17 percent have responded to treatment. Median overall survival is 11.2 months with a two-year overall survival rate of 32 percent.
the most common side effects were mostly blood and gastrointestinal problems; peripheral neuropathy was infrequent, with severe peripheral neuropathy occurring in 2 percent of patients.
According to Dr. Siegel, this combination may offer a new treatment option for heavily pretreated myeloma patients.
Abstract: http://ash.confex.com/ash/2011/webprogram/Paper37976.html
Zolinza-related news articles here at The Beacon: https://myelomabeacon.org/tag/zolinza/
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