[mikeb]

Re: Responsibilities during clinical trials in USA?

by mikeb on Wed Sep 09, 2015 9:21 pm

Lots of good points have been made in this discussion. Sorry I'm coming in so late. But I'll add my perspective anyway. I hope it's a help.

I started in a clinical trial (NCT01208662) in the U.S. in January 2013, as I began my first-line induction treatment. I found out today, during my myeloma specialist appointment, that I am now considered to have ended the trial because I stopped taking Revlimid at the beginning of August. I have now passed the limit of the number of days you can go without taking Revlimid and still be on the trial. So I am out of the trial a couple months earlier than I would have been if I had completed the 24 months of Revlimid maintenance originally prescribed in the trial protocol. (I noticed just now that the protocol seems to have been changed now to prescribe continuous maintenance until disease progression, but it was not that way when I started.)

I stopped Revlimid because it is suspected to be the cause of an abnormally slow heartrate for me that occurs sometimes, causing me to faint or begin to faint.

So my case seems to fit exactly Edna's original question. My treatment seems to have caused a new medical problem.

As Eric said, when I started the trial, it was made very clear to me what the trial would pay for and what it wouldn't pay for. And that was pretty simple as I recall. The trial only paid for the Revlimid, Velcade, and dexamethasone that I used while on the trial. My medical insurance had to pay for everything else – doctor time, tests, etc. – as well as any additional treatments that I might require due to other conditions (like my heart issue) that could be caused by the treatment during the trial.

So that's where we are. Fortunately, I have good insurance coverage and that has covered (though with co-pays, deductibles, etc, that are common in the U.S.) all of the other treatments like Zometa and pentamidine, tests, doctor time, etc. that I have needed so far. But I agree strongly with Edna's point about the unfairness of the funding / insurance situation. I am one of the lucky ones.

Hope this helps with your question, Edna.

Mike

P.S. While "flunking out of the trial" (my doctor did not like this wording, but that's how it feels) was bad news today, I did get some very good news. My bone marrow biopsy (BMB) at the end of August showed me to still be MRD negative.

[TerryH]

Re: Responsibilities during clinical trials in USA?

by TerryH on Sat Sep 12, 2015 8:57 am

Mike,

Congratulations on still being MRD negative. That's great news! Hope you stay that way for a LONG time!

[Edna]

Re: Responsibilities during clinical trials in USA?

by Edna on Sat Sep 12, 2015 10:19 am

Mike I am pleased for your treatment response, lets hope it translates into a long remission..

I am sorry you developed heart issues with Revlimid. Some people tend to have few / no problems with it and others do develop side affects, that is part of the unique picture in multiple myeloma that no one can predict. But keep getting checked up as necessary.

I also note that long term maintenance seems to be the norm now, although I have concerns that this may not be appropriate to all sub types of multiple myeloma. I am surprised the trial protocol was changed during its running, this makes reporting of data more complex.

I wonder if the organisations running these trials should be expected to set up specialist insurance to ensure that anyone joining the trial is fully insured for treatment of health conditions arising from treatment side affects. Drug companies make huge profits to pay shareholders, we are their walking laboratory for this, should they not be more responsible?

Edna

[mikeb]

Re: Responsibilities during clinical trials in USA?

by mikeb on Sun Sep 13, 2015 11:36 pm

Hi TerryH and Edna,
Thanks for the good wishes regarding my remission. I'm very fortunate.

Edna,
I was surprised that the protocol changed so dramatically during the clinical trial too. Small things have changed in the trial several times so far, and I've been given a new informed consent form to sign each time. However, I think changing from 2 years of maintenance to maintenance until disease progression is a pretty significant change. I guess it did not apply to me since I was already enrolled in the trial; I was not given a new informed consent form describing this change. And I do think it would make the data analysis more complicated, as you said.

You also raise a good question about the responsibility of the organization funding the trial to provide some insurance for patients having new health conditions as a consequence of the trial. I don't think any such system exists now, but it would be nice for clinical trial participants if it did.

As you said, we who participate in clinical trials are helping the pharma companies who are in a position to make large profits from the drugs we are testing for them. I did not think about it quite like that when I signed up for the trial, but it is true.

Instead, my main motivation was to try to play a tiny role in pushing the science or understanding of multiple myeloma forward and helping get closer to a cure. I also saw participating as hopefully a good thing for myself too, since I expected that I would be more closely monitored (for example, getting labs done monthly during maintenance instead of quarterly). I'm glad I participated in this trial. It has worked out well for me even if I didn't quite make it to the intended finish line.

Mike