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Zolinza
it appears that my wife will soon be prescribed zolinza. i would like her to consult with the oncologist who has the most experience in the country of prescribing zolinza for relapse multiple myeloma. i assume that this prescription would be with velcade-dex and possibly something else. can you refer me to the most experienced doctors with this treatment. are you the one? daniel
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DANIEL
Re: Zolinza
Dear Daniel,
Zolinza has been tested with Velcade-based therapy and with Revlimid and dexamethasone. The results in phase 1 and 2 clinical trials have been very promising, and Zolinza is now in phase 3 testing (Velcade alone or Velcade + Zolinza for patients with relapsed myeloma). We should have results of this phase 3 study at our upcoming Annual Hematology Meeting (Dec. 9-13). Prominent side effects of Zolinza include fatigue, gastrointestinal effects (loss of appetite, nausea, diarrhea) and low platelet counts. As such, treatment can be challenging and requires a careful balance of disease control and minimizing toxicity. There are a number of multiple myeloma physicians with experience using this drug, especially at centers that were involved in some of the earlier studies with this agent (Dana Farber, Hackensack, Mt Sinai in NYC, Emory, etc).
Let me know if you have specific questions about the upcoming therapy. Best of luck!
Pete V.
Zolinza has been tested with Velcade-based therapy and with Revlimid and dexamethasone. The results in phase 1 and 2 clinical trials have been very promising, and Zolinza is now in phase 3 testing (Velcade alone or Velcade + Zolinza for patients with relapsed myeloma). We should have results of this phase 3 study at our upcoming Annual Hematology Meeting (Dec. 9-13). Prominent side effects of Zolinza include fatigue, gastrointestinal effects (loss of appetite, nausea, diarrhea) and low platelet counts. As such, treatment can be challenging and requires a careful balance of disease control and minimizing toxicity. There are a number of multiple myeloma physicians with experience using this drug, especially at centers that were involved in some of the earlier studies with this agent (Dana Farber, Hackensack, Mt Sinai in NYC, Emory, etc).
Let me know if you have specific questions about the upcoming therapy. Best of luck!
Pete V.
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Dr. Peter Voorhees - Name: Peter Voorhees, M.D.
Beacon Medical Advisor
zolinza
thankyou so much for your prompt reply. i cant tell you how much i appreciate it. my specific question is to ask for the names of the best or 3 best doctors with the most experience with zolinza. i cant extrapolate doctors as lead investigators of trials into being the most experienced treating physicians. i believe that you did a zolinza clinical trial which is why i asked if you were most experienced. the names of actual treating physicians would be most appreciated. daniel
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daniel
Re: Zolinza
Dear Daniel,
The investigators from the institutions I mentioned are treating physicians who have PLENTY of experience with this drug. Yes, I was involved in a zolinza (vorinostat) study and have experience with the drug as well (but not top 3 experience) and would be happy to answer any questions you may have.
Good luck!
Pete V.
The investigators from the institutions I mentioned are treating physicians who have PLENTY of experience with this drug. Yes, I was involved in a zolinza (vorinostat) study and have experience with the drug as well (but not top 3 experience) and would be happy to answer any questions you may have.
Good luck!
Pete V.
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Dr. Peter Voorhees - Name: Peter Voorhees, M.D.
Beacon Medical Advisor
Re: Zolinza
Hi Daniel,
As you probably know, principle investigators have the most experience vs. a treating physician when the drug is not FDA approved. Once data is presented at ASH & ASCO some clinicians will begin to use the agent 'off label' but initially, the most experienced clinicians are those involved with the clinical trials who worked with the Principle Investigators. With that in mind,
Here are a couple of names:
David Siegel, MD, PhD Division Chief, Myeloma hackensack University Medical Center hackensack, NJ
Sundar Jagannath, MD Chief, Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation St. Vincent’s Comprehensive Cancer Center New York, NY
These guys have been working with Zolinza since 2008 at institutions Dr. Voorhees mentioned.
You can also find out more from them in this 2008 publication:
http://myeloma.org/pdfs/mt708_b3web.pdf
In addition there is Dr. Ken Anderson from Dana Farber, (another insititution Dr. Voorhees noted) who has been involved with development of Zolinza....more on that at this link:
http://multiplemyelomablog.com/2010/10/part-one-of-a-two-part-interview-with-merck-oncologys-vice-president-dr-eric-rubin-about-new-anti-multiple-myeloma-drug-vorinostat.html
Here is a Webinar PhaseI report from ASCO 2010 by Paul Richardson, MD at Dana Farber:
http://myeloma.org/ArticlePage.action?articleId=3057
Lastly here is a powerpoint presentation from ASH 2010:
http://www.mpn-florence.com/resources/presentations/meeting-iwg-mrt/FINAZZI.pdf
Hope this helps.
Good Luck, Daniel.
suzierose
As you probably know, principle investigators have the most experience vs. a treating physician when the drug is not FDA approved. Once data is presented at ASH & ASCO some clinicians will begin to use the agent 'off label' but initially, the most experienced clinicians are those involved with the clinical trials who worked with the Principle Investigators. With that in mind,
Here are a couple of names:
David Siegel, MD, PhD Division Chief, Myeloma hackensack University Medical Center hackensack, NJ
Sundar Jagannath, MD Chief, Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation St. Vincent’s Comprehensive Cancer Center New York, NY
These guys have been working with Zolinza since 2008 at institutions Dr. Voorhees mentioned.
You can also find out more from them in this 2008 publication:
http://myeloma.org/pdfs/mt708_b3web.pdf
In addition there is Dr. Ken Anderson from Dana Farber, (another insititution Dr. Voorhees noted) who has been involved with development of Zolinza....more on that at this link:
http://multiplemyelomablog.com/2010/10/part-one-of-a-two-part-interview-with-merck-oncologys-vice-president-dr-eric-rubin-about-new-anti-multiple-myeloma-drug-vorinostat.html
Here is a Webinar PhaseI report from ASCO 2010 by Paul Richardson, MD at Dana Farber:
http://myeloma.org/ArticlePage.action?articleId=3057
Lastly here is a powerpoint presentation from ASH 2010:
http://www.mpn-florence.com/resources/presentations/meeting-iwg-mrt/FINAZZI.pdf
Hope this helps.
Good Luck, Daniel.
suzierose
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
zolinza
thanks again dr. voorhees for your prompt reply. i am also greatful to suzie rose for the great information she has provided. i am actually zeroing in on emory which also seems to have extensive experience with zolinza. i should also note that this afternoon i noted that an abstract on zolinza/Revlimid is now available on the ash abstracts. it doesnt seem to have the efficacy of zolinza/Velcade. it was published by the new jersey group previously referred to my question for dr. voorhees centers around an emory patient's blog that seems to suggest that zolinza with cybor-d could result in at least 2 platelet transfusions weekly. that seems extreme and i am wondering, dr. voohees, if you have found that necessary in your experience. 2 infusions weekly would seem to be less than the "well tolerated" description i have read about so far. thanks. daniel
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daniel
Re: Zolinza
Hi Daniel,
I also read that zolinza is not as potent as they had hoped it would be. It seems that panobinostat is having more efficacy in multiple myeloma vs. zolinza which is working better in lymphoma.
Revlimid (lenalidomide) has a different MOA than bortezomib (Velcade) which has shown synergistic impact with Zolinza targeted at the aggresome on ubiquitin pathway of proteasome vs. the proteasome receptor sites where both bortezomib and lenalidomide are targeted.(see power point below) IOW's lenalidomide / vorinostat is synergistic, bortezomib / vorinostat is additive. However, safety profile is better with lenalidomid / vorinostat vs. bortezomib / vorinostat. Panobinostat is being touted as better combo with bortezomib. Perhaps, these are things you want to consider in terms of making a therapeutic decision.
I believe you are talking about the Vantage 095 trial, which started in 2009 & is at 42 centers, that has the combo Zolinza(vorinostat) plus Velcade (bortezomib):
".... international, multicenter, open-label clinical trial is sponsored by Merck & Co. and is part of the VANTAGE (Vorinostat Clinical Trials in Hematologic and Solid Malignancies) program. The trial will enroll 142 patients from more than 60 clinical centers including the following MMRC Member Institutions: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, Hackensack University Medical Center, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, and University Health Network (Princess Margaret Hospital). Patients must be refractory to Velcade taken alone or in combination with other anti-myeloma therapies and have been exposed to prior immunomodulatory therapies, such as Revlimid® (lenalidomide, Celgene Corporation) or Thalomid® (thalidomide, Celgene Corporation). The study will assess the objective response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination."
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Here is a 2009 power point presentation Interim Results Report by Dr.Jagannath on Vantage 088 which was Velcade arm vs a combo Velcade/Revlimid arm:
http://docs.google.com/viewer?a=v&q=cache:B59x41P33vsJ:myeloma.org/pdfs/Jagannath_8133.pdf+Vantage+088+zolinza+clinical+trial&hl=en&gl=us&pid=bl&srcid=ADGEESg5FeXqnxC0NRcoGFdvTSd6uGaCUH5vBt7LOKg7N56FW1Nyd1e8QhiMVXY1lp-KSlm42PzsLBAaYNxnvlizAww89q3UTLz0MN0TRa2Ung2TykEJWs5clwDfn9R1JhaeEfKClXKR&sig=AHIEtbShxnirLvaW_HDCAiMJeJ920WIhdg
I am certain you are correct about Emory as part of MMRC member institutions. I looked but was unable to find who the lead investigator is/was there.
I also read that zolinza is not as potent as they had hoped it would be. It seems that panobinostat is having more efficacy in multiple myeloma vs. zolinza which is working better in lymphoma.
Revlimid (lenalidomide) has a different MOA than bortezomib (Velcade) which has shown synergistic impact with Zolinza targeted at the aggresome on ubiquitin pathway of proteasome vs. the proteasome receptor sites where both bortezomib and lenalidomide are targeted.(see power point below) IOW's lenalidomide / vorinostat is synergistic, bortezomib / vorinostat is additive. However, safety profile is better with lenalidomid / vorinostat vs. bortezomib / vorinostat. Panobinostat is being touted as better combo with bortezomib. Perhaps, these are things you want to consider in terms of making a therapeutic decision.
I believe you are talking about the Vantage 095 trial, which started in 2009 & is at 42 centers, that has the combo Zolinza(vorinostat) plus Velcade (bortezomib):
".... international, multicenter, open-label clinical trial is sponsored by Merck & Co. and is part of the VANTAGE (Vorinostat Clinical Trials in Hematologic and Solid Malignancies) program. The trial will enroll 142 patients from more than 60 clinical centers including the following MMRC Member Institutions: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, Hackensack University Medical Center, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, and University Health Network (Princess Margaret Hospital). Patients must be refractory to Velcade taken alone or in combination with other anti-myeloma therapies and have been exposed to prior immunomodulatory therapies, such as Revlimid® (lenalidomide, Celgene Corporation) or Thalomid® (thalidomide, Celgene Corporation). The study will assess the objective response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination."
--------------
Here is a 2009 power point presentation Interim Results Report by Dr.Jagannath on Vantage 088 which was Velcade arm vs a combo Velcade/Revlimid arm:
http://docs.google.com/viewer?a=v&q=cache:B59x41P33vsJ:myeloma.org/pdfs/Jagannath_8133.pdf+Vantage+088+zolinza+clinical+trial&hl=en&gl=us&pid=bl&srcid=ADGEESg5FeXqnxC0NRcoGFdvTSd6uGaCUH5vBt7LOKg7N56FW1Nyd1e8QhiMVXY1lp-KSlm42PzsLBAaYNxnvlizAww89q3UTLz0MN0TRa2Ung2TykEJWs5clwDfn9R1JhaeEfKClXKR&sig=AHIEtbShxnirLvaW_HDCAiMJeJ920WIhdg
I am certain you are correct about Emory as part of MMRC member institutions. I looked but was unable to find who the lead investigator is/was there.
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: Zolinza
The HDAC inhibitors do cause thrombocytopenia (low platelets) as a side effect, and they do it to an ever greater degree when combined with Velcade (bortezomib) (which also causes thrombocytopenia). In fact, it has been hypothesized that they induce low platelet counts through a similar mechanism.
In my experience, low platelet counts are a known side effect of these treatments and DO NOT routinely require transfusions (I should note, however, that my main experience with HDAC inhibitors is with panobinostat).
That said, for clinical trials, patients require a platelet threshold to be enrolled. Patients are monitored closely for potential transfusion needs. Most patients can withstand a high degree of thrombocytopenia. As such, transfusions are not mandated until your platelets drop below 10 (unless signs of bleeding are seen). The normal level is greater than 140.
There are medications that can treat low platelets, but they are not used in myeloma or to minimize thrombocytopenia induced by therapy.
In my experience, low platelet counts are a known side effect of these treatments and DO NOT routinely require transfusions (I should note, however, that my main experience with HDAC inhibitors is with panobinostat).
That said, for clinical trials, patients require a platelet threshold to be enrolled. Patients are monitored closely for potential transfusion needs. Most patients can withstand a high degree of thrombocytopenia. As such, transfusions are not mandated until your platelets drop below 10 (unless signs of bleeding are seen). The normal level is greater than 140.
There are medications that can treat low platelets, but they are not used in myeloma or to minimize thrombocytopenia induced by therapy.
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Dr. Ken Shain - Name: Ken Shain, M.D., Ph.D.
Beacon Medical Advisor
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