[ping]

Daratumumab after an allogeneic (donor) transplant?

by ping on Wed Mar 16, 2016 3:29 am

Does anyone know if having an allogeneic (allo) stem cell transplant precludes the possibility of using daratumumab afterwards, or to which degree it precludes it?

I understand there might be clinical trials for daratumumab which don't allow people who have
had allo transplants. But that is something a little different.

Thanks, Ping

[JPC]

Re: Daratumumab after an allogeneic (donor) transplant?

by JPC on Thu Mar 17, 2016 2:35 pm

Hello, Ping:

Very insightful question.

I have done as much reading as I have been able on dara­tumumab. I have not so far heard any conflict between daratumumab and allogeneic transplants. As you correctly point out, you sometimes see exclusions in clinical trials that are conservative so that it does not complicate the clinical trial, particularly in new drug approvals.

One general observation on daratumumab, however, is that it is very new, and has been pushed through quickly based on its positive results in almost all of the scenarios where it has been tested. It may very will be case that it could turn out that it could have some mid and long term adverse impacts. In late-stage myeloma, it is no brainer, given that reaching the mid or long term, by definition, is a success.

Your specific question, however, I do not think has been addressed yet, to my knowledge, and although I don't think doctors would expect a negative interaction between daratumumab and allo transplants, daratumumab is too new to say so for 100% certain at this point I think.

[JimNY]

Re: Daratumumab after an allogeneic (donor) transplant?

by JimNY on Thu Mar 17, 2016 5:43 pm

Hi Ping,

The FDA-approved prescribing information for every prescription drug lists what are called "contraindications." These are criteria which the FDA believes should exclude a patient from taking a drug.

The prescribing information for every drug also lists "Warnings and Precautions".

In the case of Darzalex, there are no "Contraindications" in its prescribing information, and the only "Warnings and Precautions" are related to infusion reactions and the possibility that Darzalex may interfere with determining a patient's response to treatment.

I also can't think of any particular reason why you wouldn't be able to give Darzalex to someone who has had an allo transplant.

Has your doctor told you that you won't be able to take Darzalex after an allo transplant?

[ping]

Re: Daratumumab after an allogeneic (donor) transplant?

by ping on Sat Mar 19, 2016 1:18 am

Thanks, JPC and JimNY for your answers. No, my doctor has not told me that I can't use daratumumab after an allo transplant. It just crossed my mind when I was thinking of what treatments I might "lose" if I decide to go for an allo.

Thanks, Ping