[DaiCroParticipant]

From the Home Page:

It seems we will be last again.

[b]Subcutaneous injection of Velcade® is just as effective as intravenous injection[/b]

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26-04-2011
Although intravenous injections of Velcade have been effective in treating relapsing myeloma, two major drawbacks have been the need for patients to go to hospital to receive it and peripheral neuropathy, a common and debilitating side-effect of treatment.

A study published online in the journal Lancet Oncology has found that giving subcutaneous (beneath the skin) instead of intravenous injections of Velcade is just as effective in treating relapsing myeloma patients. Importantly though, subcutaneous injection reduces the risk of peripheral neuropathy.

In the study, patients were randomised to receiving either subcutaneous or intravenous Velcade on days 1, 4, 8 and 11 for up to eight cycles. The researchers, led by Prof Philippe Moreau from University Hospital, Nantes, France, found that there was no difference in overall response rates or in the length of remission between the two groups.

Of notable and significant difference was the reduction in peripheral neuropathy from 53% with intravenous dosing to 38% with subcutaneous dosing. In addition, the overall rates of other side-effects, such as gastro-intestinal disturbances, were also reduced.

Subcutaneous injection of Velcade is not yet an approved route of administration but these findings may have implications for the way Velcade is administered in the future.

[AMcGuireParticipant]

Ooooh, this is a step in the right direction. Excellent!

John has been badly affected with diahhorea from only 2 cycles of velcade so his consultant stopped treatment till he gathered up some strength again. We got him home on Friday after a couple of weeks in hospital.

Next hospital appointment is tomorrow morning (Monday 16th), I will definitely be talking about this ….. they are thinking of returning to velcade treatment but once per week instead of twice. I hope the reduced doze will lessen the side effects.

Thanks for sharing 🙂
Angelina x

[tomParticipant]

Hi Dai

Thanks for your post:-D and yes we are always LAST in the fight against anything Medical:-( why oh why cant we be at the forefront of things like this:-/ hope the lord knows cos I dont :-S

Regards
Tom

[GillParticipant]

OK I must have something very wrong here. Stephen has been having Velcade through his PICC line and has had very bad (and I mean bad) diarrhoea. His Specialist asked for a sample but was very surprised and thought it was nothing to do with the velcade. Gill (or confused from Orpington)

[DaiCroParticipant]

I have only had 3 infusions so far Gill (3rd yesterday – Thurs) and I have not had to take a single Movicol yet…. unheard of, I sniff them for a high when I've nothing better to do… I'm not in Stephen's league but I'm… chilled… laid back… incredibly loose.

Dai.

[AMcGuireParticipant]

Hi Gill

I've just got John back from a 2 week hospital stay – he had 2 cycles of Velcade then like Stephen took VERY bad diahhorea – you may have read my post "Volcanic Diahhorea"?

He was becoming terribly dehydrated and blethering a whole lot of rubbish as his body wasn't holding enough water in so thankfully was admitted for extra fluids and TLC. He was able to produce MANY samples 🙂 though they all came back clear with no sign of bugs/bacteria so it was put down to the Velcade.

Two weeks of fluids has helped though he still had intermittent diahhorea during this time and his kidney function is all doo-lally which is bad for him (he has amyloidosis which affected his kidneys). He is now home and still having intermittent diahhorea though they've given him Loperimide to slow it down (similar to Immodium). He developed low blood pressure also during his hospital stay and managed to pass out a couple of times, again just down to lack of fluids in his body. Yesterday he was back for bloods and review – kidney function is wonky, more bloods to be done in a couple of days though I don't hold up much hope for his kidneys as last night again he was having bad diahhorea – theres no end to the stuff?!

Apparently the Velcade affects nerves within the intestines. I hope Stephen and John improve very soon, its quite exhausting washing and cleaning up each day. I did however collect rubber sheeting from our District Nurse which has helped save the bed and also John is wearing pads to give him a big more confidence and not having him feeling bad about the mess he's making.

Hope Stephen and yourself get a rest sometime soon
Sending love
Angelina xx

[PerkymiteParticipant]

You know Angelina I found your post quite moving (and I do not mean Bowel wise). You are clearly working so hard to support John. I can only wish you the very best.

Velcade is something I have to look forward to apparently, I just hope the Medical Profession has read Dai's post and taken note of Tom's >:-( .

Kindest regards – Vasbyte

David

[AMcGuireParticipant]

Awe, bless you David, thank you for your kind words.

John and I met with his consultant on Monday this week, well it was with the head of the department to be precise. I mentioned the Velcade Sub-Cut to him; quite funny really …. he looked at the MacMillan Nurse ….. she looked at him …. frowning faces … eyebrows raised, dropped …. surprise … then with a squinting face he said "oh no sorry, I haven't heard of that". Agghhh!! 😀 Aren't we in the dark ages in this country? :-S During consult they toyed with re-starting John on Velcade once again, but with only 1 injection per week and at a lower dose. For the moment though, they are more concerned with kidney function so Velcade is on the back-burner. He's having more bloods done today to check kidney function yet again and they may admit him to hospital for IV fluids if the numbers are still not good. The stair-lift hasn't been fitted in the house yet, the Occupational Therapist has advised against John using the stairs meantime (he's been upstairs in bed since coming home) so I don't really know how I'm meant to go anywhere with him – maybe he'll sprout wings and fly down the stairs (avoiding all the bumps this time!), maybe should feed him some of that energy drink that sprouts the wings for you?! 😀

Well I can report that John had a diahhorea-free day yesterday – yay!! The washing machine got a break … I'm a real life living Cinderella. So a wee step in the right direction at last.

Off to feed him some pills now, that'll make him happy 😛

Wishing you a sun-shiny day David
With love
Angelina xx

[DaiCroParticipant]

From 'Pat's Place' a blog from an American MM'er.

Pat?s Place: For Me, ?Watchful Waiting? Becomes ?Hopeful Waiting?

by Pat Killingsworth
I have written about the challenges and frustrations of ?watchful waiting? here in the past.

I believe this is one of the most challenging aspects of living with multiple myeloma?sometimes all we can do is watch and wait for our myeloma to return.

But something exciting happened to me today, which has changed my whole attitude about this. I would like to share the details with you now.

During a follow-up appointment with my myeloma specialist, Dr. Melissa Alsina from Moffitt Cancer Center in Tampa, Florida, Dr. Alsina became concerned about what might be my early stages of Velcade (bortezomib)-induced peripheral neuropathy (PN).

My PN causes tingling in my hands and feet?like they are asleep?sometimes it?s worse than other times. Fortunately, my PN is not painful, although it is for many others. It?s pain and worsening of other symptoms that Dr. Alsina wants to avoid.

Normally when PN begins, oncologists simply cut back the number of Velcade treatments from two per week to one.

However, in my case, Dr. Alsina was hesitant to do that, since my monoclonal protein numbers?or M-spike?had not been dropping as quickly as she anticipated. Since I am scheduled to undergo a stem cell transplant at Moffitt in June, it was hoped the induction therapy combination of Revlimid (lenalidomide), Velcade, and dexamethasone (Decadron), which I had never tried before, would drop my numbers significantly in a matter of weeks.

So we faced a dilemma: Reduce my weekly treatment from two doses to one in hope my PN wouldn?t progress?or risk a painful increase in my PN by remaining aggressive and sticking with the double weekly dose.

Dr. Alsina?s solution was to recommend I switch to a brand new way of administering Velcade, subcutaneously (or subQ), instead of by IV push.

Dr. Alsina reaffirmed the results of studies I had read, which showed that subQ Velcade was less likely to cause serious PN than Velcade administered by IV.

?I didn?t even know subQ Velcade was available yet,? I remarked, surprised.

She replied, ?We have been using it here for several weeks.?

Let me explain. The formula of the Velcade itself is the same, but it is reconstituted differently for subcutaneous injection vs. intravenous.

Millennium Pharmaceuticals?the makers of Velcade?filed for approval of this new method of administration for Velcade with the Food and Drug Administration (FDA) in late March. However, doctors are already using the product ?off label,? meaning before the FDA has approved this administration method.

I suspected subQ Velcade wouldn?t be available at my smaller, local clinic, the Florida Cancer Institute. This was confirmed when I met with my medical oncologist, Dr. Malhotra, there on Tuesday.

?I believe we can get it.? Dr. Malhotra said. ?But I have never used it before?it is too new. Dr. Alsina is a specialist. She is more cutting edge than we can be here. If she says it is a good idea, I will review the literature and speak with her about it.?

Sure enough, when I arrived for the first of my two weekly treatments the next day, Dr. Malhotra had issued the order and I received the first subQ Velcade shot given by Florida Cancer Institute.

Can you say guinea pig?

So what? Why is this such a big deal to me?

Sure, it means I will need to undergo fewer IVs, and that should save some time and discomfort. But that?s not it. There?s more.

Two years ago, I attended a briefing on experimental drugs Millennium had in the pipeline. SubQ Velcade was one of the listed ?drugs of the future.?

But for me, the future is now! Since I have never been part of a clinical trial, this is the first time I have experienced an experimental multiple myeloma drug becoming a reality. Here I am?a short two years later?using Velcade in a new and safer way.

I never dreamed something like this could happen so quickly! To use a drug that only a short two years ago was in clinical trials leaves me feeling uplifted and hopeful.

Hopeful. Maybe we should change the phrase from ?watchful waiting? to ?hopeful waiting!? Velcade subQ is proof that new, experimental drugs are on the way?hopefully in time to help you and me live longer and better.

[b]Feel good and keep smiling! Pat[/b]

The fact that our consultant's are hanging back and waiting on this is becoming ridiculous. As Pat rightly says:

[b]'For me, the future is now!' [/b]

As it is for all of us. Can Myeloma UK push this forward?

Dai.

[JentayParticipant]

Dai, the very first report I read about Velcade being administered subcu was headed "Not to be released to the British Press". (I'm not sure if it was on the link I sent you some while back.) That says it all, doesn't it?
However, it's really worrying when specialists haven't even heard about the latest research. Surely if we can find out what's happeniing, they should be able to do so.

Re. the diarrhoea. I did have bouts of it when I was on Velcade but nothing as bad as people here have reported. I also found that it continued for at least a year after I finished the treatment, so that may be worth bearing in mind.

I am on Revlimid at the moment and after a bumpy start it's been great. My pps have fallen from 40+ to 4 after three cycles. Fingers crossed they drop to zero!

Jen.

[DaiCroParticipant]

Excellent news regarding Revlimid Jen, let's hope it continues down to cr and a plateau that will last for years. As I have noted here before, I met a woman at the Nottingham INFOday who has been on Revlimid for 5 coming on 6 years, it simply works for her with a minimum of side-effects.

I must say that after 3 years of Movicol and Micralax as my best friends I would gladly swap for a mild case of concurrent dissentry. 😛

Can I ask how long you got after Velcade? My consultant is swinging between 6/12 months but I have read reports that where successful with early cycles (4/6) that 14/18 months have often been achieved. Of course I realise that we are all different but its good to hear/see experiences that open the range.

Yes, the 'British Press' remark wasn't lost on me… and here is the beauty of the internet, the people's press (a la twitter and injunctions et al) – its just how to raise the questions with our medics and to get them addressing it with perhaps one centre willing to make it break.

Here is hoping.

Dai.

[JentayParticipant]

I had six courses of Velcade, Dai, and they lasted me 14 months before I had to start the latest round of treatment. I was very reluctant to go on Revlimid and asked to have Velcade again on the principle of "better-the-devil-you-know". However, after a horrible first month this has been so much easier, ie. no twice weekly trips to the hospital and less side-effects. I shall be delighted (that may be a bit too strong!) to stay on it if it continues to work.

Hope Velcade works as well for you as it did for me,
Jen.

[ellenModerator]

Dear Dai

Thank you for your post about subcutaneous Velcade. We have been tracking the development of subcutaneous Velcade for some time. The data are impressive and the company have submitted a file for an extension to their current licence. It is likely that they will receive this, but we are not exactly sure when. When they do, it will need to get approved for use on the NHS. We are not 100% sure what the approval mechanism will be, but we are working to find that out.

Until it is approved for use on the NHS, it will not be widely available. That said, we know of a number of doctors who are using it now via what is called off-label use. We expect this use to steadily increase.

In addition, there are a number of trials in the pipeline in the UK which include subcutaneous Velcade, including one in our own Early Phase Clinical Trial Network.

Ellen

[DaiCroParticipant]

Thank you Ellen.

From what I understand the reservations have been based on overall efficacy, that seems to have been answered, so I do hope that a method with equal efficacy and superior management of side-effects will soon be the order of the day. (I am about to start Cycle 2 and my consultant did say that I might get subQ administration within my planned cycles). 🙂

I won't hold my breath but I am breathing slightly easier.

Dai.

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