[MariParticipant]

Hi folks,

Stephen has just started his 5th cycle of Velcade which he has been receiving subcutaneously. All has gone well so far and his side effects have been minimal. However when he went into our local hospital on Tuesday for his usual injection he was told that Velcade c ould no longer be given by subcutaneous injection. He received his dose as an injection intravenously, not an infusion, so it did not take long. However I assume he now risks the possibility of great side effects.

Apparently this has come about due to an edict from the MRHA (Medicines and Healthcare products Regulatory Agency). The administration of Velcade subcutaneously has not been licenced but I know many people have recieved this way so I am not sure what has suddenly changed. I wondered if anyone else had come across this or if maybe Ellen knew anything about it. It seems a great shame, especially if more people can tolerate velcade if given in this way.

Who should we lobby to bring about a change for the better? I think I know the answer, it's good old NICE again.

The good news for Steve however, is that after 5 cycles his paraproteins are down to less than 2, undetectable. We go to see the contsultant early next month to consider our next steps. I know Steve is wondering about an allo SCT, he is one of four, but worries that he is too old at 55. Does anyone have any thoughts about this?

Thank you for youe help and I hope no one is being deprived of sub cut velcade that really needs it,

Love Mari xx

[BADGERParticipant]

Hello Mari

glad Stephen is doing well I know my hospital Lister in Stevenage is not licenced but I have regular visits to UCH and they do so lets hope its soon run out all over the country
Regards Jo x

[jillsParticipant]

Hi Mari,

Glad to hear Stephen's result were good. Mum had her injection yesterday as usual, last one of the first cycle and they booked her in for the next cycle, no mention of problems with sub cut administration. Could it be a local problem in your area? I hope there isn't a wider issue as i am not sure Mum would cope with intravenous injections. She is still doing fine at the moment.

Interested to hear if you find out any more details,

Love,

Jill

[eveParticipant]

Hi Mari
Have nothing to add about Velcade.
Did Steve only get enough stem cells for one chance,from what I can see for allo SCT,you would have to convince them its viable.They like a back to back ,your own sc then a few months later a donor .Eve

[ellenModerator]

Hello Mari

I am glad to hear that Stephen is doing well on Velcade with minimal side-effects and that his paraprotein is less than 2.

Velcade is currently only licensed by the Medicine and Healthcare Products Regulatory Agency (MHRA) to be administered intravenously and is approved by NICE on this basis.

In the USA, the Food and Drug Administration (FDA) have recently approved the use of subcutaneous Velcade in myeloma and in Mid 2011, Janssen, the pharmaceutical company responsible for Velcade, applied for a license in Europe through the European Medicines Agency (EMA) to administer Velcade subcutaneously. The decision on this is due to be published in the Summer 2012. If this method of administration receives approval at the European level, it can then become available for myeloma patients in the UK. However, there may need to be an additional step involving NICE approval but at present, it?s not clear whether NICE will become involved.

As the data on subcutaneous Velcade are strong, and because of the positive decision in the USA, we are confident that this method of administration is likely to receive approval by the EMA. Myeloma UK has been following this process with interest and we will be updating our supporters on the outcome of the EMA decision.

If you have any questions on the MHRA assessment of sub cut Velcade, please contact my colleague Kate on +44 0131 557 3332 or email kate@myeloma.org.uk

[MariParticipant]

Hi Eve,

Steve got about four and a half million stem cells from his harvest which they put back all in one go, so he does not have any in reserve for a second auto graft. In addition because his remission only lasted a year i dont think they will consider it good enough for a second auto so maybe we are clutching at straws asking them to consider a Allo but we will see. We have to stay positive.

Slim is going in for his SCT on Monday isn't he? I remember that ward in Kings so well, the staff are lovely there. I wish you both well as you take this big step,

Love Mari xx

[MariParticipant]

Thank you Ellen, thats helpful, hopefully sub cut velcade will be licenced soon so that everyone can benefit from it.

I notice one of our contributors in Ireland has been having Velcade regualrly for about a year. Does this kind of maintenance treatment get used in the UK, it sounds like a good idea. I am beginning to get a feeling for the economics of myeloma treatment.

Do you know much about carfilzomib, I know, through Dai that the Aspire trial is going on. Is this likely to become a treatment in the near future?

Thanks for all your helpful input,

Mari

[jillsParticipant]

Hi Ellen,

Thanks for this interesting post. Maybe this is a stupid question but if Velcade is not licenced for subcutaneous use in the UK how come some patients like my Mum are receiving it in their local hospital this way? Her consultant seemed to have no trouble arranging it and I know there are others there having the same?

Maybe it is best not to ask….!

Jill

[Author]

Posts