As Dr. Shain says, you need to be in good enough physical condition to be included in a clinical trial. After relapsing and the disease running rampant again and you have not responded to the other treatments, it is hard to be in good shape. This happened with our daughter. Two rounds of high-dose chemo did not work, the only thing it did was make her sick, weak, and low blood counts, while at the same time plasmacytomas were growing in her body.
So it seems to me that the sickest of patients who need something new are not given the opportunity of a clinical trial.
Forums
Re: Stay in clinical trial or pursue other treatment?
Thelime,
In case you aren't reading all the other threads in the Beacon, note that dara was just approved today for use in R/R patients with three prior lines of treatment. I "believe" your wife has been on three other therapies if I am reading her history correctly.
https://myelomabeacon.org/forum/fda-approval-daratumumab-t6359.html#p37841
Take care.
In case you aren't reading all the other threads in the Beacon, note that dara was just approved today for use in R/R patients with three prior lines of treatment. I "believe" your wife has been on three other therapies if I am reading her history correctly.
https://myelomabeacon.org/forum/fda-approval-daratumumab-t6359.html#p37841
Take care.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Stay in clinical trial or pursue other treatment?
Dear all,
As a previous poster noted, daratumumab is now approved by the FDA. But, before yesterday's approval, any oncologist could have requested daratumumab for a multiple refractory patient from Janssen's compassionate use program. If the patient fit the inclusion criteria for the expanded access program, the patient would be referred to that program, but if the patient didn't fit those inclusion criteria, they would have been eligible for consideration to receive daratumumab through compassionate use. If their request was granted, they would have received the drug at the facility where the requesting physician worked.
Hope that answered some questions!
As a previous poster noted, daratumumab is now approved by the FDA. But, before yesterday's approval, any oncologist could have requested daratumumab for a multiple refractory patient from Janssen's compassionate use program. If the patient fit the inclusion criteria for the expanded access program, the patient would be referred to that program, but if the patient didn't fit those inclusion criteria, they would have been eligible for consideration to receive daratumumab through compassionate use. If their request was granted, they would have received the drug at the facility where the requesting physician worked.
Hope that answered some questions!
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citygirl
Re: Stay in clinical trial or pursue other treatment?
Our doc discussed the expanded access program about six weeks ago. He mentioned he had applied for the compassionate use route for dara and found it took longer to get approved. He did not recommend trying that route based on his experience. Thankfully, FDA has approved dara. We see the doc in 2 weeks and will discuss where dara might fit in to therapy.
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philatour - Who do you know with myeloma?: spouse
Re: Stay in clinical trial or pursue other treatment?
Wonderful news about daratumumab. Thanks for offering us the best info.
Another concern is the infusion time. Our doctors treatment room is so busy I am worried he is not going to want to tie up his room for so long.
Would you recommend trying Pomalyst and dex only first to see how that works (Pomalyst worked extremely well before).
Or go straight to daratumumab?
Another concern is the infusion time. Our doctors treatment room is so busy I am worried he is not going to want to tie up his room for so long.
Would you recommend trying Pomalyst and dex only first to see how that works (Pomalyst worked extremely well before).
Or go straight to daratumumab?
Re: Stay in clinical trial or pursue other treatment?
I am not a doctor or medical person. I have been through some of the same situations with my husband - also high risk refractory.
clinical trial - they will tell you when the disease has progressed and they are taking you off the trial. You may not need to get in front of it. Did they advise about how long the drug takes before it is effective?
standard of care protocols - Ask what it is and what are the decision points are for discontinuing a regimen earlier than expected. Otherwise assume you are in for the recommended number of cycles. Pomalyst and Revlimid are longer acting drugs. Lower dose (2 mg v 4 mg) of pomalyst may help with white blood count response. They take longer to kick in and last longer in the system. They are in the same class of drugs (immunomodulary) and a significant majority of patients respond well to them. My husband did not respond well to either one, either with dex alone or in combination.
I did speak to a center with the expanded access program. Here's what I remember: weekly infusion for 8 weeks; then every other week for 4 weeks/cycles (not sure which); monthly infusion thereafter. infusion time is progressively shorter with time on the therapy. The first infusion is over 8 hours. 50%+ of the patients experienced infusion reaction, tantamount to a bad cold/sinus and a case of pneumonia creating heaviness in the chest. The infusion was stopped when reaction occurred, patients were treated and, when the treatment kicked in, the infusion was restarted. Figure on 10 hours of elapsed time with the first infusion . Few if any of the patients had the infusion reaction in subsequent cycles. If well tolerated, infusion time is reduced to 6 hours. The shortest infusion time on the expanded access is 4 hours.
clinical trial - they will tell you when the disease has progressed and they are taking you off the trial. You may not need to get in front of it. Did they advise about how long the drug takes before it is effective?
standard of care protocols - Ask what it is and what are the decision points are for discontinuing a regimen earlier than expected. Otherwise assume you are in for the recommended number of cycles. Pomalyst and Revlimid are longer acting drugs. Lower dose (2 mg v 4 mg) of pomalyst may help with white blood count response. They take longer to kick in and last longer in the system. They are in the same class of drugs (immunomodulary) and a significant majority of patients respond well to them. My husband did not respond well to either one, either with dex alone or in combination.
I did speak to a center with the expanded access program. Here's what I remember: weekly infusion for 8 weeks; then every other week for 4 weeks/cycles (not sure which); monthly infusion thereafter. infusion time is progressively shorter with time on the therapy. The first infusion is over 8 hours. 50%+ of the patients experienced infusion reaction, tantamount to a bad cold/sinus and a case of pneumonia creating heaviness in the chest. The infusion was stopped when reaction occurred, patients were treated and, when the treatment kicked in, the infusion was restarted. Figure on 10 hours of elapsed time with the first infusion . Few if any of the patients had the infusion reaction in subsequent cycles. If well tolerated, infusion time is reduced to 6 hours. The shortest infusion time on the expanded access is 4 hours.
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philatour - Who do you know with myeloma?: spouse
Re: Stay in clinical trial or pursue other treatment?
Thanks, lots of great info. We will hopefully know the results of the PET scan today. We are already trying to get appointments with a myeloma-specific doctor.
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