Revlimid and High Risk MDS RAEB 2 - 18% Blasts

[Peachy]

Hello all - It has been sometime since I have even visited this site. Now I'm back now with another question. First I would like to thank all of you that post and share. Our lives and those of our loved ones change so quickly reminding us not to put off what is important. I have met so many great people on this site. Thank you all.....

My husband started with MDS, moved to AML, has been through the Induction/Consolidation but the blasts are now climbing once again, indicating return of AML.

Has anyone had experience with Revlimid and MDS(18% blasts)? He is not a candidate for BMT. He started with RAEB 1, moved to AML, back to low risk MDS and now back to high risk MDS RAEB 2.

Not many options given to us - Do nothing, 5 days of Chemo, Revlimid and hunt for clinical trial
Our research has shown that most trials will not accept him because of secondary cancer (squamous in lymph nodes removed in Sept.)
Chemo called Clofarabine - I have heard of this and am also on LLS site, but the doc didn't think it was a good option.

Suggested treatment - Revlimid, though its effectiveness deemed to be low, and maybe a small chance it may keep the blasts at bay.

We have an appointment at University Hospital in Denver tomorrow for another opinion.

Would appreciate any insight. And again I thank all of you who post frequently on this site for your time and support.

Peachy

[bailie]

Peachy, you might have missed this video someone posted. It is the best lengthy video concerning MDS that I have watched. The speaker (Dr. Gail Roboz) is good and presents very well. It is long, but well worth the time.

https://live.blueskybroadcast.com/bs...=1418&CAT=8549

[Peachy]

Thanks Ballie. Should have listened to treatment one first..will have to do that later today. Look before you click! Peachy

[vickij]

I was on revlimid for 2 months before transplant for MDS .My blasts were only 5% but the revlimid put me in remission. The transplant Dr was going to put transplant on hold but was afraid I would lose donor so we went ahead with transplant. My prayers are with both of you.

[DanL]

There have been a couple of trials out there that combine revlimid and azacitidine with pretty high success rates, and there is another with azacitidine and pracinostat that has had an 80-90% success rate in inducing remission. Not sure what the underlying requirements are, but there have been a couple of forum members on these as I recall.

So far as I know, revlimid alone has not been that successful in the absence of a del 5q, but has worked in up to about 30% of patients in the lower risk category without 5q.

[bailie]

I was on revlimid and azacitidine prior to SCT. It worked for me. There are so many different disease interactions with MDS, I think it is as much a guessing game trying to find what works as a scientific approach. Or a combination trying to cover as many bases as possible.

[Birgitta-A]

Hi Peachy!
As Dan wrote Revlimid can work in a little less than 30 % of low risk patients without the 5qdel (I belong to this group).

The trials with Vidaza and Revlimid have showed different results. Here is one study with positive results: https://ash.confex.com/ash/2014/webp...aper71196.html

I have seen studies where they give the patients up to 50 mg Revlimid and I think that is a very high dose. I started with 5 mg and continued with 10 mg, that worked one year for me but at that time I had low risk MDS.

There are really special tests now that will show who will respond to Revlimid but these tests are only performed by researchers.

Hope Revlimid will work for your husband!
Kind regards
Birgitta-A

[Peachy]

Hi Brigitta - Thanks for the link. I am actually getting pretty good at reading all the medical jargon! Will ask the doctor today, the one thing that jumped out at me was that is was primarily used with patients who had not had any precious treatment. Stats aren't particularly good, but were are not a stat.

I believe the Doc is starting us at 10 mg of Revlimid. Will keep a close watch on him, should we decide to go that route.

Wonder how we can get a test to see if it would work, but maybe just having a little hope that it may work will be enough.

Your spirit is amazing!

Hi Ballie - will definitely bring the combo up to the Doc we are seeing this afternoon.

Hi DanL - we do not have del 5q. The only thing that has come up for us is chromosome 6, which at first they said was inverted and when relooking with this last BMB really shows that chrom 6 is stealing from chrom 3, which is why it looks inverted and longer. Really trying to figure that out. This is all new with the last 2 BMB's. Will take all the names of drugs with me today and will look for the forum members talking about the combo.

Hi Vickij - The doc did say Revlimid works better with lower risk MDS, which we are definitely not - your 5% blasts vs our 18%. We felt as if it were being offered this as the choices were so few. We have been told that the effectiveness will probably be very low. I am so happy it worked for you.

Having said that you have all given me another potential direction and have armed me with questions. Thanks so much!

[Peachy]

My husband is very encouraged.

We are so glad we went for a second opinion, because had he started with Revlimid alone as suggested, he would have not been even considered for clinical trial (below). We are also thankful to our Doc for getting us the appointment for the second opinion so quickly.

Yesterday we met with the University of Colorado, had an additional BMB, and he is being considered for 2 trials.

One is for the gene mutation of IDH - which he is being checked for (thus the additional BMB), which has the best remission rate, so far.

Second - Azacidine (Vidaza) and letolinimide (Revlimid) with the hope to get blasts down to "remission" level. If accepted, he will have vidaza shots for a week followed by 21 days of Revlimid (50mg), which is a really high dose. While this combination is not easy to tolerate early signs show it could have up to a 50% response.

We will know in a week to 10 days after results of new BMB.

(Thanks DanL and Ballie for making us sound good - the doc was surprised we even knew the names of the drugs! I forgot to ask about the other trial, but will do so next week when we get the BMB results). The fact that the combo worked for you Ballie is also very encouraging.

If accepted, we will then meet with another BMT doc to see if he now qualifies for a BMT. He was disqualified last year because of squamous cell cancer in lymph nodes. Those lymph nodes have now been removed. While we have not met with Doc yet, it is encouraging. The goal is remission then right into BMT.

I thank you all in advance for listening and your support.

On another note - I mentioned we were so thankful that we traveled. I need to clarify that by saying we traveled extensively Pre-MDS to Alaska, Europe and many other places. Our travels since our MDS diagnosis have been minimal, in between shots, transfusions, chemo and when not living in our neutropenic "bubble" at home. MDS and AML and the treatments required always come first for us.

[bailie]

Peachy, "Second - Azacidine (Vidaza) and letolinimide (Revlimid) with the hope to get blasts down to "remission" level. If accepted, he will have vidaza shots for a week followed by 21 days of Revlimid (50mg), which is a really high dose. While this combination is not easy to tolerate early signs show it could have up to a 50% response."


Again it is an individual situation for sure, but when they added Revlimid to my Vidaza I felt zero side effects. Also, this was done for me without being part of a study/trial. My doctor just did it. The studies have supported this use.

[Birgitta-A]

Hi Peachy!
Here is a study showing the results bailie wrote about - 50% response rate in 16 evaluable patients: https://ash.confex.com/ash/2014/webp...aper68934.html

As bailie reported both drugs are approved even if Revlimid perhaps isn't approved for your husband's type of MDS - this means that he should be able to get this treatment "off record" if his doctor is allowed to prescribe Revlimid.
Kind regards
Birgitta-A

[Peachy]

Thanks Ballie and Birgitta for helping me think outside the box!

My husband has already been approved for the drug Revlimid - 10mg. The pharmacy is waiting to hear when we want it sent, which is on hold until we hear about the study.

Do you remember your dosage Ballie?

So if not accepted for the trial we will talk to our doc about doing the combo.

Thanks!

[Birgitta-A]

Good Peachy!
Kind regards
Birgitta-A

[Peachy]

Thanks Birgitta for the link. We are actually talking with Dr. Pollyea who is running the study.

[rar]

Originally Posted by Peachy

My husband is very encouraged.

We are so glad we went for a second opinion, because had he started with Revlimid alone as suggested, he would have not been even considered for clinical trial (below). We are also thankful to our Doc for getting us the appointment for the second opinion so quickly.

Yesterday we met with the University of Colorado, had an additional BMB, and he is being considered for 2 trials.

One is for the gene mutation of IDH - which he is being checked for (thus the additional BMB), which has the best remission rate, so far.

I was treated by Dr. Pollyea for a mutated IDH2 gene with a drug(ag221) from Agios. I responded positively, got the blasts down, and had a transplant 7 months ago. There were some bumps in the road to recovery. Today I went to CU hospital. They said I am recovered enough that a local doctor can monitor my condition and no more driving to Aurora. If you are interested I can give you more details. I also had my port removed.

Ray

[Peachy]

Morning Ray -

I am very interested. Any and all information is helpful, as we continue our journey. Do you want to start a thread about the IDH or Private message me? Either is great!

Trying to remember where you are located in Colorado - we are in the Springs.

I remember reading some of your first posts before I got so involved in my own life that I didn't visit the site.

I am thrilled you are doing so well!

[rar]

You can private message or use the forum.

I was diagnosed with MDS RAEB 2 and was told that my only chance for a cure was stem cell transplant. Before getting a SCT they wanted my blasts don to less than 5% from the 14% they were at. They were recommending Vidaza but told me it had less than 40% success rate. Dr. Pollyea call me and told me that I had a rare gene mutation and that they were doing a clinical trial on AG221 which selectively attacks the mutant IDH2 gene with very little side effects. In the first month my blasts went from 14 to 4%. In the second month blasts were 1%. My platelets, WBC, and RBC remained critically low. In the whole trial I was the only one that responded like that. Dr. Pollyea advised me that to date all drug responses have been temporary and he as not expecting AG221 to be any different, and that with my low blood counts having low blasts was not that much of an advantage. The low blast count put me in a good position for a SCT and that is what he advised.

Agios is the creator of AG221. Their web page is at:
http://www.agios.com/index.php

Google search will turn up a lot more info and the clinical trial results.

Have you been diagnosed with mutant IDHx? It is not common. Mutant IDH2 occurs in about 5% in MDS and 15% in leukemia. Without the mutation AG221 does not work. I will try to answer any specific questions you might have.

We found very good lodging for the months we had to spend in Aurora after the transplant. We live 50 miles north of UC. 1.25 hour drive, or 1.5 hours in rush hour.

Ray

[Peachy]

Thank you Rar - Your post and information is encouraging.

We will know next week whether he has the IDH mutation. His counts are low already and whites spent about a month in the critical low with a bump in numbers the last 2 weeks, so am thinking which ever trial he is in will be a challenge in that regard.

In the meantime I went back and read many of your posts. You had quite a few challenges. Again I am so happy you are doing well now.

Where you finally decided to do your BMT? Peachy

[rar]

I ended up in UC after carefully considering PSL and UC. DanL choose PSL so you might ask him also. My reasoning as follows in sort of random order of importance.

US News ranked UC #1 in CO PSL #9 see http://health.usnews.com/best-hospit...NC&distance=25

PSL does more transplants. UC says their program started more recently and is ramping up.

UC in safer looking newer area with better parking.

UC has more research and clinical trials.

Hospitals can take weeks to months to share data. I did clinical trial at UC and was not sure how long it would take my data to get to PSL

We found free lodging for the 3 months we would have to stay in Aurora. Both places were less than a quarter mile to UC, 5 to PSL.

Dr. Pollyea, I think, is primarily a research doctor. He did my clinical trial. Dr. Gutman was my SCT doctor. They were both very thrifty with their words. Not much bedside manners. Both have excellent reputations as doctors. To an extent other UC professionals such as PA's made up for some of that. Dr. Nash from PSL is somewhat older, has an excellent reputation and was recommended by my brother in law. Dr. Nash gave the impression that a team of 9 doctors consulted on you case and they all saw you. UC seem to have a smaller team and except for a brief stay in the hospital I only saw Dr. Gutman.

Both hospitals seem to have 1 year survival rates around 70%.

I may seem biased toward UC, but it was a close call. In the end Dr. Nash seemed like a nicer guy but I was concerned with record sharing and familiarity between the patient and the staff and visa versa that UC had after doing clinical trial.

Who knows if I made the right decision. But UC brought me back from the brink of death where Poudre Valley couldn't seem to help.

By the way I suspect he will be having a SCT rather than a BMT.

I had WBC and ANC counts less than 0.1 or not measurable. Platelets were as low as 11. This didn't seem to concern anyone.

In case you are interested the hospital billed just over a million dollars for my care. Medicare paid about 100,000 or ten cents on the dollar. Without insurance not many could afford the hospital rate. In my case there was little that Medicare did not settle on.

Ray

[Peachy]

Thank you Rar for all the info. We visited with a Dr. Bierman last year, when my husband where they decided he was not eligible for a BMT, which you are probably correct is really a SCT.

After we hear on the trials we are to see Dr. Gutman as well.

We have already experienced the 0.1 WBC's and below 11 platelets when he went through Induction/Consolidation chemo and kidney failure - so I know how scarey it is.

Not surprising about the billing. Sometimes I think that many hospitals over bill Medicare to get what they can and maybe get somewhere in the neighborhood of getting expenses back. Am thankful my husband is on Medicare.

My brother had a liver transplant at UC in 2009 and I don't think charged nearly as much. He was covered with private insurance. I do know that private insurance covers more of the actual cost than medicare, thus charging more. That is entirely a different subject.

Thanks for helping me through this process. Waiting axiously for results of BMB. I actually witnessed the BMB for the first time - that was an experience. Peachy

[DanL]

I can't say much about UC. What I can say is that for transplant, CBCI was ranked #2 nationally for its size and was beaten out by a children's unit, so we are apples to oranges. The quality of care was extremely good, and we did see and talk to most of the doctors over the course of my inpatient experience. Also, for ongoing treatment, my case has been reviewed by the team of doctors for any changes that have been major, which in my case has been a few times due to relapse and drug reactions. As for medical billing - having worked in the insurance industry for too many years - each insurance company, including medicare and the supplement plans - have negotiated rates. The hospital has a billed rate for service, and then charges the insurance company based on that negotiated rate. I never really paid any attention to what the hospital charged as the "billed rate" but know that the negotiated rate was under $80k for the total inpatient experience, which I thought was a great deal for my life. If only I could buy a house or a car with that kind of negotiating power.

The point of my post - as Ray noted, it is very important to be comfortable with your doctors, hospital, and team as a whole. I have had a great treatment and transplant experience where I am at, and it sounds like Ray has done very well with UC as well. I think that the more we trust our teams, the better our chances of recovery because it removes doubt from our minds, even if the paths are different from person to person and facility to facility.

[Peachy]

Hello All - Just an update. Life has been like a roller coaster since I last posted. We completed the first round of the clinical trial and will find out how or if it affected the MDS/leukemia at all in 2 weeks.

The big change - even though we thought we were approved for the SCT, apparently we weren't really. They wanted a PET scan before they gave their final blessing. Unfortunately that scan showed that my husbands squamous cell cancer was back in the lymph nodes and has now moved into his lung. So we have been removed from the SCT treatment and the clinical trial - azacidine (Vidaza) and remlivid.

The only options they are giving us at this time are palliative (hospice) or going back and forth treating the squamous then the leukemia. As they consider both incurable, they are not very encouraging.

As his MDS has now moved back to leukemia, along with the squamous, I should probably move more toward the leukemia discussion boards, Just wanted to give you all an update. Everyone on this site has been so supportive and quick to share. I have enjoyed it very much and I thank you all! I can only hope that his leukemia drops a back down to MDS once again.

I was so sad not to have had a chance to say a final word to Birgitta, who was such a inspiration.

Peachy