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  #26  
Old Sat Sep 17, 2011, 07:33 PM
Sally C Sally C is offline
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Hi Linda,
Thank you for your kind note. Have been keeping up with your posts. I certainly wish you and Al the best. Please keep us posted.

Hi Birgitta,
Thank you for the clarification of a subcapsular cataract. This was new to me.
I pulled up your 70 page link. After skimming through it my eyes are now crossed. You and I need to sit over a case of wine and let you explain all of that to me.
Thank you too for your kind words and your willingness to always share you vast knowledge and support.

Best wishes to you both and will keep you posted.
Sally
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  #27  
Old Sun Sep 18, 2011, 01:16 PM
Birgitta-A Birgitta-A is offline
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Promacta

Hi Sally,
It should have been very nice to meet you and discuss Promacta but I live in Sweden and only travel in my own car because I am so afraid of infections.

You know I have been waiting several years for reports on Promacta in MDS patients - many of us have low platelets and need treatment. Good that Don is participating!

In the report from Europe you can see that 7% of the patients got some kind of eye disorders - 2% was cararact, 1% dry eye, 1% blurred vision, 1% lenticular opacities and 1% other diseases.

2% is not much considering that the study patients had the autoimmune bleeding disease ITP. Many of these patients had been treated with Prednisone or similar drugs that can give cataract. The problem is that rats got cataract when they got large doses of Promacta and that is why they suspect that cataract could be an adverse effect.

Did they control Don's eyes before he got Promacta?
Kind regards
Birgitta-A
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  #28  
Old Sun Sep 18, 2011, 02:34 PM
Sally C Sally C is offline
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Hi Birgitta,
They did do an extensive exam of Don's eyes before starting Promacta. The doctor made note of something she saw in his eyes but didn't take any pictures so we don't know if it was the beginnings of cataracts - which is what they saw with his 2nd exam. They took over 100 pictures at his 2nd exam so they should have what they need for comparison. You mentioned Predinose - Don is on a 2 month slow taper of Prednisone for a colon inflammation. Started at 20mg. per day for 2 weeks and has been dropping 5mg. every 2 weeks until he finishes the last 2 weeks at 5mg. per day. I don't know if Predinose is the only steroid that can cause cataracts. If other types affect it, that could have worked against him as well as he always gets an IV dose of Solu-Medrol - which is also a steroid - with every transfusion to help prevent reactions.
Thank you for answering as always and will keep you posted.
Take care,
Sally
Well Birgitta, just out of curiosity I looked up Solu-Medrol and one of the side effects they specifically noted was posterior subcapsular cataracts. You are truly a storehouse of knowledge. I'll swear with these drugs you're damned if you do - damned if you don't. You just have to pick your poison. Thanks again for the information.

Last edited by Sally C : Sun Sep 18, 2011 at 03:13 PM. Reason: Additional information
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  #29  
Old Mon Sep 19, 2011, 08:06 AM
Birgitta-A Birgitta-A is offline
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Promacta

Hi Sally,
Yes most drugs are dubble edged swords. You know I am so afraid of adverse effects of drugs that I only accepted supportive therapy the first 4 years after dx. Now I take a very low dose of Thalidomide and 5 mg Prednisone with good effect on my counts. I can only hope that I won't get any adverse effects.
Kind regards
Birgitta-A
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  #30  
Old Fri Jan 27, 2012, 02:08 PM
Sally C Sally C is offline
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Hello all,
Just wanted to update you on how Don's doing in the Promacta clinical trial he started in March, 2011 at the National Institutes of Health in Bethesda, Md.
First of all he has tolerated Promacta without any problems whatsoever.
He has been transfusion independent since spring of 2011 except for one transfusion of red cells in Oct. He had been transfusion dependent since 1/09 with approx. 60 transfusions in '09 and the same in '10 - for both red cells and especially platelets.
He has gone from RBC's in the 7 and 8's to 11.2 this week. (1/25/12). His platelets had been totally refractory since '09 - low point being 4,000 but for the most part staying in the teens or lower. They were 61,000 this week as well.
They did a BMB this month and I will paste the summary from our doctor we received yesterday. I might add that he received Campath in April, 2009 with a minor partial response and received Cyclosporine from late fall, 2010 until starting the Promacta in March, 2011 with no response.

"Everything looked good. Overall, his bone marrow was 40-50% cellular which is a little more than last July. There was no increase in blasts and no change in overall fibrosis (still 2 out of 4). His chromosome analysis still shows the deletion 20q in 90% of the cells analyzed. There were no other chromosomal abnormalities.
...His bone marrow has more cells than it did in July which makes sense since his blood counts have improved. Overall, it isn't much different than the July marrow. I think it was 30-40% cellular at that time if I'm not mistaken. Someone Mr. Calvert's age should have about 35-40% cellularity, but with MDS that can vary.
The main thing is that the cells we saw looked good as opposed to there being blast cells (which is what we do not want to see!)."

They only have 4 people in the Promacta/MDS trial now so I'm sure they are more than open for new patients.
I would appreciate any input from the Marrowforums experts re: the increase in cellularity and the fact that the deletion 20 was in 90% of the cells analyzed. Do either have any meaning in the overall picture?
If anyone has any questions please feel free to ask.
Thanks so much and God Bless.
Sally

Last edited by Sally C : Fri Jan 27, 2012 at 02:20 PM.
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  #31  
Old Fri Jan 27, 2012, 03:05 PM
Birgitta-A Birgitta-A is offline
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Promact

Hi Sally,
Congratulations to Don and you ! Wonderful results with very good counts and no increase in fibrosis or blasts in the bone marrow!

As you know del20q is a "good" chromosome aberration. Promacta is no chemo so I don't think you could expect any decrease in the % of cells with the chromosome aberration.

As far as I understand increased cellularity should be a good sign.
Kind regards
Birgitta-A
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  #32  
Old Fri Jan 27, 2012, 03:18 PM
Sally C Sally C is offline
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Thank you Birgitta,
You are not only a great source of knowledge - you are everyone's cheerleader.
Thank you for your kind words of support.
God Bless,
Sally
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  #33  
Old Fri Jan 27, 2012, 10:23 PM
Greg H Greg H is offline
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Hey Sally!

That is truly great news! Glad to hear it.None of those BMB results sound bad at all, as Birgitta has said.

Congratulations!

Greg
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Greg, 59, dx MDS RCMD Int-1 03/10, 8+ & Dup1(q21q31). NIH Campath 11/2010. Non-responder. Tiny telomeres. TERT mutation. Danazol at NIH 12/11. TX independent 7/12. Pancreatitis 4/15. 15% blasts 4/16. DX RAEB-2. Beginning Vidaza to prep for MUD STC. Check out my blog at www.greghankins.com
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  #34  
Old Sun Jan 29, 2012, 02:35 PM
Sally C Sally C is offline
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Greg,
Thank you so much for your kind words as well. You too are a storehouse of knowledge and a great support for all. Your wit and way with words not only make your posts enjoyable - you make difficult information easy to understand.
While I'm here I want to again post the MDS/Promacta clinical trial contact information that has helped Don's platelets so much.
Thanks again Greg!
Sally

Barbara Weinstein RN BSN CCRP
NHLBI/ Research Nurse Specialist
Building 10 CRC Room 5130
10 Center Drive
Bethesda, MD 20892
phone: 301-594-4180
fax: 301-594-1290

Last edited by Sally C : Sun Jan 29, 2012 at 03:25 PM.
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  #35  
Old Sun Jan 29, 2012, 03:29 PM
Birgitta-A Birgitta-A is offline
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Promacta

Hi Sally,
Thank you for giving info about Promacta trials. You know when I got my dx 2006 with platelets at 65 I understood that I should need treatment for low platelets. I have been following Promacta and the other drug for low platelets called Nplate during 6 years now.

There are several studies in MDS patients about Nplate and we know since several years that Nplate can give increased fibrosis and blast in MDS patients.

There are still no reports about Promacta in MDS patients but in cell lines from MDS patients the drug has had a positive effect.
Kind regards
Birgitta-A
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  #36  
Old Sun Jan 29, 2012, 03:38 PM
Sally C Sally C is offline
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Hi Birgitta,
Do you know how long it took for Nplate to cause problems with fibrosis and blasts?
Will keep you posted on Don. So far so good. Will be a year in March since he started.
Thanks as always!
Sally
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  #37  
Old Sun Jan 29, 2012, 04:15 PM
Birgitta-A Birgitta-A is offline
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Nplate

Hi Sally,
That is a difficult question because the researcher report that increased blasts and fibrosis in MDS patients can depend on the disease. That is true of cause. The latest reports from ASH 2011 tell us that Nplate has a positive effect in MDS.

The same year FDA wrote "On 18 February 2011, the independent Data Monitoring Committee (DMC) for a randomised clinical study of Nplate in MDS patients with thrombocytopenia recommended to discontinue Nplate in all patients due to the increased risk of progression to AML. In this study, there were numerically more subjects in the Nplate arm with disease progression to AML (placebo 2, Nplate 9) and with increases in circulating blasts >10% (placebo 3, Nplate 25). The randomisation was 2 to1, Nplate to placebo. Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML compared to lower risk.
"
http://www.imb.ie/images/uploaded/do...22.09.2011.pdf

I still hope Promacta will function better for us.
Kind regards
Birgitta-A
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  #38  
Old Mon Jan 30, 2012, 03:09 AM
Nadia T Nadia T is offline
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Thanks so much for this information. I'm leaving for NIH this weekend to start the Campath trial. Though all my numbers are low, my platelets are the biggest concern, so I'll be sure to ask about this.

By the way, did the Campath help?
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  #39  
Old Mon Jan 30, 2012, 10:08 AM
Sally C Sally C is offline
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Hi Nadia,
Don had Campath in the spring of '09. He had a partial response with only his white cells. But I do believe it also saved his life.
I don't know if you will have the same protocol. He received Campath for 10 days in the hospital. I think I read somewhere that they are giving Campath as out-patient now and possibly a lower dose.
I think you have to wait a while before you can take Promacta after Campath. They do wait approx. 6 months to see if you respond although sometimes it can take longer. But you may get a great response and your platelets won't be a problem.
NIH is wonderful!!! And the doctors are so accessible and helpful. It's a first class operation - a real healing, positive, upbeat place. You couldn't be in better hands.
Keep us posted. Good luck and God Bless!
Sally
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  #40  
Old Mon Jan 30, 2012, 01:03 PM
Greg H Greg H is offline
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Nadia,

Much good luck with the Campath. The first couple of doses are kind of scary, with the rigors and all. But it's pretty boring by the end of the ten day cycle.

I sure hope it works for you. Keep us posted!

Take care!

Greg
__________________
Greg, 59, dx MDS RCMD Int-1 03/10, 8+ & Dup1(q21q31). NIH Campath 11/2010. Non-responder. Tiny telomeres. TERT mutation. Danazol at NIH 12/11. TX independent 7/12. Pancreatitis 4/15. 15% blasts 4/16. DX RAEB-2. Beginning Vidaza to prep for MUD STC. Check out my blog at www.greghankins.com
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  #41  
Old Fri Feb 3, 2012, 09:40 PM
Lisa Z Lisa Z is offline
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Nadia!

Good luck with the Campath trial. I went through it in March 2009. While all my counts have not gone to normal, my platelets went from 40 to 140 and my whites and reds, and hemaglobin, while still low, I am living a normal life.
I haven't been sick since the trial, other than the usual winter upper respiratory stuff I always got anyway. Never a fever and my hemaglobin is trying hard to get to normal range. I do also have PNH though, and that is likely the cause of it not climbing any higher.
I feel I could live a normal, long life with my current counts. Haven't had a transfusion since June of '09.
NIH is great! My 2 primary docs are no longer there, but I'm sure the care is still the best!
I haven't been on anti-virals for a LONG time and really am only taking thyroid meds, since the Campath screwed up my thyroid.
So, basically, I do not have to be treated for my MDS at this point; I have been in remission since June '09.
I hope you have a great success story to share soon!
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Dx. 6/08 with AA, then changed shortly thereafter to MDS. Campath trial at NIH March '09 and have been transfussion independent since June '09
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  #42  
Old Tue Apr 17, 2012, 07:14 PM
Sally C Sally C is offline
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Hello all,
Greetings from Bethesda, Md.
Just wanted to give you an update on Don's success with Promacta which he started taking 3/11. Today his platelets were 91,000 and his reds were
11.5.
Just to put in perspective - he was transfusion dependent from 1/09 until spring of 2011. He needed about 120 transfusions in 2009 and 2010. His platelets at one time got down to 4,000 so you can see the unbelievable improvement.
They also checked his eyes again for a worsening of subcapsular cataracts. The eye surgeon we saw today said she wasn't sure she would even call them cataracts as the eyes change as we age. But the main thing is there has been no worsening of whatever they want to call it.
The NIH doctors are even talking about cutting back on the Promacta if his platelets hit 100,000 out of concern for blood clots. They have this concern because clots appeared on lab rats so they are just being careful. He has an atrial fib/flutter and they actually want us to ask his cardiologist about a blood thinner. We'll see about that.
He has had absolutely no side effects from the Promacta that we can tell.
Also NIH is still recruiting for the trial for AA as well as MDS. If anyone has any questions about this please feel free to contact me. shcalvert3@aol.com.
God Bless to all,
Sally

Last edited by Sally C : Tue Apr 17, 2012 at 11:20 PM.
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  #43  
Old Tue Apr 17, 2012, 07:59 PM
Lisa Z Lisa Z is offline
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Promacta

Just for future reference, do you have a link to this protocol? Thank you, and continued good luck!
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Dx. 6/08 with AA, then changed shortly thereafter to MDS. Campath trial at NIH March '09 and have been transfussion independent since June '09
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  #44  
Old Tue Apr 17, 2012, 08:18 PM
Sally C Sally C is offline
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Hi Lisa Z,
I'm more than glad to provide the link - and thank you for your best wishes.
http://clinicaltrials.gov/ct2/show/NCT00961064

Here is the contact info...
Barbara Weinstein RN BSN CCRP
NHLBI/ Research Nurse Specialist
Building 10 CRC Room 5130
10 Center Drive
Bethesda, MD 20892
phone: 301-594-4180
fax: 301-594-1290

Best wishes to you too!
Sally

Last edited by Sally C : Tue Apr 17, 2012 at 11:18 PM.
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  #45  
Old Tue Apr 24, 2012, 06:16 PM
Sally C Sally C is offline
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Promacta (Eltrombopag) Update

My husband Don started on Promacta in March, 2011 with platelets that had stayed in the teens for 2 years - once getting as low as 4,000. (You can read about it in more detail under "Clinical Trials".)
As of yesterday his platelet count was 116,000. They are now going to start cutting back on the Promacta - 25mg. every 2 weeks - until he gets below 100,000. If I'm not mistaken this is so there won't be the danger of causing blasts.
They are still wanting new patients for this trial. Don has tolerated the Promacta without any problems whatsoever.
Best wishes,
Sally
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  #46  
Old Wed Apr 25, 2012, 05:56 AM
Birgitta-A Birgitta-A is offline
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Promacta

Wonderful Sally!
Kind regards
Birgitta-A
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  #47  
Old Wed Apr 25, 2012, 01:29 PM
tytd tytd is offline
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promacta success

Hi Sally,
That is so great that Don has responded to the Promacta. 116k wow!. I wondered if you knew how the other patients on the trial were doing? I think that you said in the beginning that Don had a hypoplastic marrow so I wondered if people like me with hyperplastic marrows might not tend to respond so well or be more prone to blasts developing. Also I think you mentioned that Don had Atrial fib. Did that develop before or after starting the Promacta? Here's hoping for continued success and thanks for posting the news. tytd
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possible low to int-1 MDS with predominant thrombocytopenia, mild anemia, dx 7/08, in watch and wait mode
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  #48  
Old Wed Apr 25, 2012, 05:12 PM
Sally C Sally C is offline
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Birgitta,
Thank you for the kind words.
Tytd,
Don was hypocellular to begin with but that changed to hypercellular before the Promacta so that shouldn't be an issue.
He started Promacta in March, 2011 and had the heart problem in Sept., 2011. According to what the NIH doctors have told us there have been no issues with the heart in previous Promacta trials. (AA trials started before MDS trials.)
This is only a guess but his heart issues could have been a result of all the steroids he received as part of the pre-meds before his many transfusions. He was prone to reactions - especially with his platelet transfusions.
We haven't been told of the results of the other MDS patients in the trial - there are only 3 others. They have had good success with their AA patients with the Promacta not only helping with platelets but with red cells as well. Promacta helped Don with both lines also - in fact one thing I forgot to mention was that last week was the first time since 12/08 that Don's Hgb was in the normal range.
Please let me know if you want any further information and thank you for your kind words as well!
Best wishes,
Sally

Last edited by Sally C : Wed Apr 25, 2012 at 06:02 PM.
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  #49  
Old Thu Apr 26, 2012, 04:01 AM
Neel Neel is offline
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revolade experience

My father started revolade 50 mg on 02 april 2012. He tolerated it well for first week, but no improvement in counts. However in the second week he developed fever and is hospitalised since 14 april. His urine culture now shows infection , so the resaon looks like uti . It sems that he developed uti due to revolade. There is stil no improvement in ciunts, on the contrary the drop in his platelet count is unprecendented. He require platelet every alternate day now. His fever is also not under control and only subsized for 4 hrs after taking paracetamol. We have now stopped revolade since ysday. Any inputs

Regards neel
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Father age 64 diagnosed with MDS RAEB-2, with 15%-18% blasts in October 2010. Only had blood and platelet transfusions. Ayurvedic treatment which showed result for arnd 5 months. Started Tahlidomide 100 mg started on 22 nd April 2011. Revolade 50 mg started on 2 nd april 2012.
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  #50  
Old Thu Apr 26, 2012, 05:45 PM
Sally C Sally C is offline
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Neel,
I am very sorry about your Dad no matter what the cause. I'm sure you are very concerned. One of the many things that is so wicked about these diseases is what may help one may hurt another.
I wish you and your Dad the best.

And to correct one of my previous statements...
Quote:
Originally Posted by Sally C View Post
As of yesterday his platelet count was 116,000. They are now going to start cutting back on the Promacta - 25mg. every 2 weeks - until he gets below 100,000. If I'm not mistaken this is so there won't be the danger of causing blasts.
I asked NIH why they don't want his platelets over 100,000. They do this out of concern for clots. The MDS patients have the same protocol as ITP patients - some whose platelets went over 200,000 - so they set the limit at 100,000.
Sorry for the misinformation.
Sally
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