[DaiCroParticipant]

Many of the regulars who have been on this board for over 6 months or so will have heard me banging on about the efficacy of Kyprolis (which started life off as Carfilzomib). I missed out on the original trial in January of last year by one week… I passed every qualification except for the presence of myeloma in my urine… they closed the entry to the trial 5 days before the myeloma caught up with my pee but then it was too late and I had to settle for Revlimid & Dex (the original trial was Carfilzomib – Revlimid – Dex).

Carfilzomib received its licence from the American Food & Drugs Agency (FDA) last June and now trades under the name of 'Kyprolis'. Kyprolis is the first new drug to come on line for MM since Revlimid in 2006. I have been hanging on in hope of Kyprolis becoming available in the UK but they seem to have been dragging their heels over here. My consultant, who desperately tried to get me on to the original trial, was very bullish about Kyprolis… she was convinced of its efficacy and was sure it would be excellent both as a drug for relapsed patients as well as being an eventual first class frontline treatment.

Well it is now here in the form of a trial [b]Myeloma 5[/b] which is part of a dual trial with Myeloma 6 which is Velcade based. You can find full details of the trials in the 'News' section on the home page but I have put the Myeloma 5 details below. I would encourage any relapsed patients on or beyond the Revlimid stage to discuss the trial with their consultant… I will be, starting on my pre-Bendamustine consult on Monday.

Dai.

[quote]MUK five

MUK five is a Phase II study of carfilzomib (Kyprolis?) with cyclophosphamide and dexamethasone in comparison to bortezomib (Velcade®) with cyclophosphamide and dexamethasone.

MUK five aims to recruit 300 relapsed and/or refractory myeloma patients throughout the UK. Prof Kwee Yong, based at University College of London Hospital (UCLH), is the Chief Investigator for this study. The study is comparing carfilzomib to Velcade with a view to producing data that will help the approval of carfilzomib for use on the NHS.

Myeloma UK Research Programme Manager, Heather McKinnon said, ?MUK five is a good example of how the Myeloma UK CTN works to ensure data is available at the right time to quickly and effectively bring new medicines into UK clinical practice.

?While carfilzomib is not currently available to patients on the NHS, we?re pleased to enable access to such a promising treatment through the CTN and we are confident the data gathered during MUK five will help inform the UK approval process.?

MUK five will be the largest study yet to run in the CTN expanding the Network from the current eight to twelve hospitals with other hospitals across the UK due to participate in the near future.

Carfilzomib was granted licensing and marketing approval by the US Food and Drug Administration (FDA) as a treatment for relapsed and refractory myeloma patients in the US in August 2012. It is expected the European Medicines Authority (EMA) will make a decision on carfilzomib approval in Europe later this year.

[/quote]

[eveParticipant]

Hi Dai

It is good news,I hope if the medication you are on does not work I hope you get this one 500 people only,as you said it has to show in urine,

I worry that as Slim did not respond to thalidomide how well will he do on Revidimide ,and if the same conditions apply,he will not qualify for the new trials.

Any one heard from Keith????
Love Eve

[janwParticipant]

Hi, This is my first post, but I have been looking at this site for the past year meaning to participate at some stage. The range of help and advice offered on the site is tremendous and much welcomed. At aged 53, I was diagnosed with kappa light chain myeloma in April 2010 and undertook 4 cycles of CDT followed by a SCT in August 2010. Fortunately, my light chains reduced from 2,200 to around 30. However, over the past two years the light chains have been steadily increasing and now stand at around 575. I panicked recently because following a cold virus in December my light chains increased by 200, but thank goodness after a couple of months they reduced to their usual level. But I realise I am slowly approaching my first replapse which would be velcade, or if available,perhaps the MUK five trial which is why I started to make enquiries about the trial.

MUK 5 appears to be a stage two randomised trial comparing carflizomb, with cyclophosphate and low dose dexamethosone (CCD) against velcade, cyclophosphate and low dose dexamethosone (CVD)for first relapse or primary refractory mm. Out of the 300 selected for the trial, half will be aged 18-64 and the other half aged 65 years and over. The Chief Investigator for this trial is Prof Kwee Yong from University College of London Hospital (UCLH), and this centre is already recruiting patients. Other hospitals across the UK are also preparing to open this trial but there is no exact date for these at the moment, although it is anticipated to be within the next few months.

It appears participants will be randomised 2:1 ratio in favour of CCD. The proposed study will compare 8 cycles of CVD with 6 cycles of CCD, and will also assess the benefit of maintenance carfilzomib in participants in the CCD arm. Participants in the CCD arm, who have at least stable disease at the end of the initial 6 cycles of CCD, will be randomised to receive maintenance therapy with Carfilzomib or no further treatment. Participants in the CVD arm will not receive maintenance therapy.

For anyone wishing to find out more details about MUK five, you can contact Heather McKinnon who is the Clinical Research Programme Manager at Myeloma UK, either my email heather@myeloma.org.uk or call 0131 557 3332.

The trial looks interesting, particularly as this is the only way in the UK you can access the promising drug carflizomb/kyprolis, as well as possibly receiving maintenance treatment.

Jan

[eveParticipant]

Hi Jan

Welcome to the site,and I am sorry you are going out of remission.

I might be wrong on this but reading present information. To be eligible forMUK. 5 I think you have had to had Revidimide ,you do not say if you have been on MX1 trials???.
I thought the criteria was you have had to have had Revidimide ,before acceptance on these trials!!!!

I can only say Jan Velcade worked ver well for my husband,CDT had no effect but Velcade worked,he had SCT,,but because it no longer shows in blood or light chains I asked for a BMB because the last one was 6 months previous ,the results show 10percent myeloma cells in bone marrow,the previous BMB it was 0 percent .
I personally would like to see some trials of Velcade as maintenance !!!

[janwParticipant]

Hi Eve,

Many thanks for the welcome to the site.

When I was searching for information on the MUK 5 and 6 trials, I found no specific mention of the inclusion criteria requiring participants to have taken Revlimind prior to these trials, but they did specify the maximum number of previous treatments in their inclusion critera, presumably some of which could include Revlimind?

On the UK Clinical Research database portfolio, the MUK 5 trial outlines the main aim of the trial is to assess the effectiveness of Carflizomb, Cyclophosphamide and Dex (CCD) against Velcade, Cyclophosphamide and Dex (CVD)for relapsed/refractory patients with no more than one line of previous treatment, plus to assess the effectiveness of Carflizomb being used as maintenance treatment.

On the EU Clinical Trials register, the MUK 6 trial is detailed as a phase 1/11 trial looking at Velcade, Thalidomide, Dex (VTD) and Panobinostat treatment and Panobinostat maintenance for relapsed and relapsed/refractory multiple myeloma patients who have received one to four prior lines of treatment. The purpose of the trial is to look at the doseage of Panobinostat and the response rate within 16 cycles of VTD-pano, as well as determining the feasibility of Panobinostat maintenance.

At least both trials are looking at the effectiveness of maintenance treatment. Although in the UK we appear to be a long way behind America with our availablity of new myeloma drugs and range of maintenance treatment, hopefully these latest myeloma trials will decide whether the UK will provide maintenance treatment under the NHS.

Just like Velcade worked for your husband, my consultant has also recommended this treatment as being the most effective treatment for light chain myeloma which is why I was interested in the MUK 5 study which appeared to be a win-win situation of either taking Velcade or Carflizomb with the possibility of maintenance. When I attended one of last year's myeloma info days, the results for Carflizomb appeared to be very impressive.

Jan

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