One year ago, the wife had her autologous stem cell transplant…in the Myeloma community this is seen as a kind of “birthday”…
There were two “harvests” and she still has some millions of cells in a bag at “L’Etablissement Français du Sang”. This means that she could have another go at high dose chemotherapy stem cell transplant at some stage in the future…
This was used to aid the harvests…
Granulocyte colony-stimulating factor (G-CSF or GCSF), also known as colony-stimulating factor 3 (CSF 3), is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
Functionally, it is a cytokine and hormone, a type of colony-stimulating factor, and is produced by a number of different tissues. The pharmaceutical analogs of naturally occurring G-CSF are called filgrastim and lenograstim.
G-CSF also stimulates the survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils.
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Hematopoietic stem cells (HSCs) are the stem cells that give rise to other blood cells. This process is called haematopoiesis. In vertebrates, the very first definitive HSCs arise from the ventral endothelial wall of the embryonic aorta within the (midgestational) aorta-gonad-mesonephros region, through a process known as endothelial-to-hematopoietic transition. In adults, haematopoiesis occurs in the red bone marrow, in the core of most bones. The red bone marrow is derived from the layer of the embryo called the mesoderm.
Haematopoiesis is the process by which all mature blood cells are produced. It must balance enormous production needs (the average person produces more than 500 billion blood cells every day) with the need to regulate the number of each blood cell type in the circulation. In vertebrates, the vast majority of hematopoiesis occurs in the bone marrow and is derived from a limited number of hematopoietic stem cells that are multipotent and capable of extensive self-renewal.
Hematopoietic stem cells give rise to different types of blood cells, in lines called myeloid and lymphoid. Myeloid and lymphoid lineages both are involved in dendritic cell formation. Myeloid cells include monocytes, macrophages, neutrophils, basophils, eosinophils, erythrocytes, and megakaryocytes to platelets. Lymphoid cells include T cells, B cells, natural killer cells, and innate lymphoid cells. The definition of hematopoietic stem cell has developed since HSCs were first discovered in 1961. The hematopoietic tissue contains cells with long-term and short-term regeneration capacities and committed multipotent, oligopotent, and unipotent progenitors. Hematopoietic stem cells constitute 1:10,000 of cells in myeloid tissue.
HSC transplants are used in the treatment of cancers and other immune system disorders.
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She still has a measure of:
Hypogammaglobulinemia is a problem with the immune system in which not enough gamma globulins are produced in the blood (thus hypo- + gamma + globulin + -emia). This results in a lower antibody count, which impairs the immune system, increasing risk of infection. Hypogammaglobulinemia may result from a variety of primary genetic immune system defects, such as common variable immunodeficiency, or it may be caused by secondary effects such as medication, blood cancer, or poor nutrition, or loss of gamma globulins in urine, as in nonselective glomerular proteinuria. Patients with hypogammaglobulinemia have reduced immune function.
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I probably already know more about Myeloma and the state of art in terms of treatment than is healthy. I have read more epidemiology and clinical trial data than many in the medical profession.
This time last year the wife had just started her high dose chemotherapy – stem cell transplant treatment for her multiple myeloma. The high dose chemotherapy was brutal completely wiping out the immune system and killing all her fast growing cells. They gave her a dose which was intended for people slightly younger than her and she had a very tough time of it. The idea is to “wipe the slate clean” and then rebuild with her stem cells which had been previously harvested and stored in a freezer in DMSO.
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This had to be done in sterile conditions and under strict observation in Rennes 150 km away. We had both had Covid prior to the treatment and I was suffering with post-Covid bronchitis and therefore infectious and taboo as a visitor. I was on a fairly high dose of steroids and a special inhaler. Later I made quite a few round trips and had to have the house clean and sterile for her return nearly three weeks later. There was not much May in the garden for her last year.
It was just the two of us…with visits from the district nurses.
There was a lot of tiredness, severe gastric problems, much sleeping and a broken foot for summer as well as an operation on her shoulder. Through the wringer is an appropriate and apt expression.
Today things are calmer, Charlie-boi has gotten his fancy hat and the geriatrics are planning to run for president of the US of A again.
We went up to the coast to Trévou-Tréguignec and the beach was almost deserted. There was no traffic on the roads.
After the bedlam of last year things are much quieter and we do not get as many loyalty points on our hospital loyalty card as we once did.
I get the feeling that the world, humanity is pretty darned stuck, in the doldrums and going nowhere.
Charlie-boi did not look overjoyed with his gig, he looked a bit glum. Not much “joy to the world”.
Globally there is a leadership vacuum. The “old guard” are showing a marked longevity and there are no obvious up and coming “new blood” to take the world stage.
In the background we have the odd conversation about moving house. We can afford one more summer here now that we have someone to drive the sit on mower. Perhaps that is it, make up for a “lost summer” for last year. Enjoy it here before the world gets even more crazy.
The wife still gets tired but can now work for over an hour in the garden. Bowie the cat likes it when we are both out there. She has been a bit stir crazy with the recent rain.
There is a big difference between May ’22 and May ’23…
And of course, there is the Rugby World Cup later this year…
We shall go for a meal next week for the anniversary…
Bristol Myers said on Thursday its revenues in the quarter were $11.34 billion, below analysts’ expectations of $11.49 billion, according to Refinitiv data.
CFO David Elkins said that revenue in the quarter grew by 10% if you exclude products like Revlimid that have lost their exclusivity as well as the impact of foreign exchange.
Sales of Revlimid, which began facing generic competition last year, fell to $1.75 billion in the quarter, down 37% from $2.8 billion last year.
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From Bristol Myers web site
—- Bristol Myers Squibb posted first quarter revenues of $11.3 billion, a decrease of 3%, due to Revlimid generic erosion and foreign exchange impacts, partially offset by in-line products (primarily Opdivo and Eliquis) and our new product portfolio (primarily Opdualag, Abecma and Reblozyl). When adjusted for foreign exchange, revenues decreased 1%. Our revenues for in-line products and new product portfolio increased 8% to $9.3 billion, or 10% when adjusted for foreign exchange impacts.
— U.S. revenues increased 4% to $8.0 billion in the quarter primarily due to Eliquis, Opdivo and our new product portfolio, partially offset by Revlimid generic erosion. International revenues decreased 16% to $3.3 billion in the quarter. When adjusted for foreign exchange impacts, international revenues decreased 11%, primarily due to Revlimid and Eliquis generic erosion, partially offset by Opdivo and our new product portfolio.
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This means as high quality generics become available at a lower price more people will be able to have life saving Lenalidomide now that the patent has expired.
I maintain that UK pharma is missing a big pile of cash by not investing in and chasing the lucrative generics market.
In, out, in, out You shake it all about You do the hokey cokey And you turn around That’s what it’s all about
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Her Royal Highness Bowie the ex-stray cat has gone all cockney. Her favourite game now is the door hokey-cokey. One minute she wants to go out, next minute she wants to be in. Although she may be a Russian Grey, she is not all that fond of the cold. Now that the weather has started to turn, she is much keener on going out. She has started hunting birds nesting in the yew hedges. It is possible that we shall have a few corpse “presents” in due course. She also likes “security” when exploring the garden. If something freaks her out, she can run to one of us. At the moment she is outside hassling Felix the stray sedentary male tom, who does not understand very much. Bowie has been manipulating him ever closer to the door. The light may be on but I am not sure there is anyone home, Felix would not get a place on a University Challenge team.
We have had 751 kg of Propane delivered. We are still on mates’ rates and the bill should arrive soon. If we buy, off peak, two cubic metres of commercial wood, then that means we have gas until January and wood until April. An early tank of gas in January will still be on the mates’ rates contract. Fuel security should therefore be OK for a year.
We got our annual letters from USS, the universities superannuation scheme. The amount has gone up with UK inflation. Mine is a little over £1000 a month in total now. I only paid in for 13 years so the sum accrued is not much. Together our income will fall below the threshold for French taxation. We will have to pay the equivalent of poll tax. This is due in October. I’ll submit my normal tax returns by May.
Looking at the definition below we live amongst the 14% of the population in poverty, though it does not really seem like that. We are not that expensive to run.
With the man coming to drive the sit on mower it looks like we have the wherewithal to stay here for another calendar year. At the moment the Myeloma is not causing the wife {and us} too many problems.
We may be able to enjoy spring-summer-autumn without any Covid lock downs, or highly invasive medical procedures. For now, the frequency of medical appointments is low.
I have even caught a little sun today…working on my tan…
I have an early one, 5-6 AM tomorrow…a 270 km round trip to the port…
I get to wake Bowie the cat up for a change.
We shall see how she copes with me at 5 AM tomorrow…
😉
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“Poverty is not exploding in France. It is evolving. With a relative income poverty line set at 60% of the median standard of living – or €1,000 per month of disposable income for a single person and €2,500 for a couple with two children – poverty is fairly stable, at around 14% of the population. But, more important than the figures for a given year, are the long trends and transformations. After the Second World War, poverty was a phenomenon affecting the elderly. Today, the picture is very different: it affects mainly young people, it is concentrated in certain problematic urban areas, and it concerns single-parent families over large ones. Finally, proportionally, it increasingly affects working poor and foreigners. A stable poverty rate disguises these transformations and concrete problems: the growing share of constrained household spending, particularly housing costs.
The income poverty rate (percentage of people living on €1,000 per month of disposable income) in France – at 14% – is below the European average of 17%. In total, the European Union is estimated to have 87 million poor people, including 13 million in Germany, 12 million in Italy, 10 million in the United Kingdom… and 9 million in France. This favourable situation in France compared to the EU is due in particular to the high level of social spending and redistribution.”
Today while the wife was getting her Zometa intravenous treatment to help with the possible effect of Myeloma on her bones and bone strength, I went into the supermarket at the local “city”. {~16,000 people} The place was a little like the Marie Celeste as many people are turning out to protest against the pension reforms.
Around here more locally, during the weekdays, the supermarket has grey-hairs, pensioners, like us and young mothers as clientele. Not so in the “city”. Because of the age and health profile of the locals here, wearing a surgical mask in the supermarket is still the norm. One does not have to, but around 20% still do. The wife is immune compromised so we both still tend to wear masks in public, her FFP2 and me surgical.
I am 95kg and muscular. I wear desert combat trousers and have recently had a short buzzcut. Because people around here are generally small and slight, I do look a bit like a brick shithouse.
In the supermarket today I was the only one wearing a mask.
I was incongruous. Several people stopped and did a double take.
Why was this big lump still wearing a mask?
Any way today I am not only incongruous as a being, I looked that way too!!
Luckily the UK is using the money it saved by leaving the EU to fund treatments on the NHS…
I have just received my Myeloma UK Newsletter…
The wife has had the above quartet therapy here in France, where efficacy seems more important than cost.
Does it work?
Yes…
Let’s prescribe it then.
This is French pragmatism and does not require endless committee work…nor as many bang per buck calculations.
Another reason to stay here and not return to blighty…
Humans or sterling…
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8 April 2022
“daratumumab (Darzalex®) is not recommended for use within NHSScotland.
Indication under review: in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
In an open-label, phase III study, the addition of daratumumab to bortezomib, melphalan, and prednisone was associated with a significant improvement in progression-free survival.
The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows:
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.”
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“A new treatment that could improve survival and boost remission by two years for patients ineligible for transplant has been given an initial knockback by NICE.
The National Institute for Health and Care Excellence (NICE) has turned down the use of daratumumab (Darzalex®) in combination with lenalidomide (Revlimid®) and dexamethasone (DRD) for the treatment of newly-diagnosed myeloma patients who are not eligible for high-dose therapy and a stem cell transplant.
Yet, DRD has been shown to improve life expectancy and increase average remission times by two years compared to lenalidomide and dexamethasone alone and is already available in other countries.
This is an interim decision by NICE, which will be reviewed after it looks at more data.
Around two thirds of newly-diagnosed myeloma patients are ineligible for a transplant. DRD would have allowed over 3,000 patients to access daratumumab at first line for the very first time.
Although NICE acknowledged that DRD was effective, its appraisal committee felt it could not accurately confirm whether the treatment was cost-effective for the NHS, based on the available data.”
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Daratumumab has been available at first line for newly-diagnosed patients eligible for a stem cell transplant across the UK since December 2021.
Prof. Gordon Cook, Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, said:
“Daratumumab in combination with lenalidomide and dexamethasone is a ‘game-changer’ treatment in myeloma which prolongs disease control and improves survivorship. I hope that we can have access to this treatment combination in the imminent future for all patients ineligible for a transplant so that as many patients as possible will benefit.””
One of the prime considerations if we are to move is proximity to a Haematology department. At the moment there is a once a week clinic at Guingamp, but that may change. The nearest stable Haematology is likely to be at Saint-Brieuc. The sword of Damocles posed by multiple myeloma means that we don’t know when the disease will return. We do need to factor in perhaps single story living and reduced garden size because my osteo-arthritis will not get better, a downstairs bog could be important. We do not want to do much decorating, there are some pretty rum {loud} designs here.
At the moment we rattle around in this big house.
To my surprise this afternoon I have found two smaller places at roughly the same valuation as ours a little north of Saint-Brieuc. I guess the plan is to do a viewing or two and see what we feel about the notion. One of them is in walking distance of a beach, where there are two {in season} restaurants. I could easily take up fishing again.
The feelings will inform us more than the thoughts.
Location then halves the available living space. It also halves the heating bills…
So, on Monday we shall try to fix up some appointments…
Sandoz launches generic lenalidomide in 19 countries across Europe, expanding access to essential oncology medicine
Feb 18, 2022
Lenalidomide Sandoz is indicated for use in several critical haematology-oncology conditions, per latest ESMO guidelines.
Cost savings from Lenalidomide Sandoz can expand treatment options for patients with haemato-oncology conditions.
Sandoz is committed to developing and providing generic oncology therapies, to provide patients access to affordable, high-quality medicines
Basel, February 18, 2022 — Sandoz today announced the launch of generic oncology medicine lenalidomide, indicated for several haemato-oncology conditions as recommended by the latest European Society for Medical Oncology (ESMO) guidelines. The medicine will become available to patients in 19 countries across Europe.
“We are proud to make life-enhancing cancer treatments more accessible by launching our affordable and effective Sandoz Lenalidomide”, said Rebecca Guntern, Head of Sandoz Europe.
She added: “Sandoz is committed to developing and providing generic oncology therapies, to increase patient access to affordable, high-quality medicines. Today, we offer a broad portfolio of more than 50 oncology products, ranging from biologics to chemotherapeutics, hormones and supportive care treatments, covering a wide range of cancer indications.”
The cost of treating multiple myeloma patients is high and continues to rise. Affordability of and access to new multiple myeloma treatments pose a major challenge around the world. Cost savings from Lenalidomide Sandoz promise to expand access to treatment options for multiple myeloma patients. Similar to multiple myeloma patients, cost savings from Lenalidomide Sandoz will benefit previously treated follicular lymphoma patients, adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality, and relapsed or refractory mantle cell lymphoma patients1.
Sandoz is the #1 provider of generic oncology medicines in Europe with a growing portfolio that covers an industry-leading 75% of molecules on the WHO’s global Oncology Essential Medicines List Sandoz invests in development to improve the lives of cancer patients and free up healthcare resources through increased access to high-quality, affordable medicines.
About Lenalidomide
Lenalidomide is an oral thalidomide analogue with immunomodulatory, antiangiogenic, and antineoplastic properties used for the treatment of various haemato-oncology conditions. Lenalidomide is recommended by the latest ESMO guidelines. It is available only through special distribution program because of its serious side effects, including possible birth defects or death of an unborn baby . Lenalidomide is available as hard capsules and need to be taken exactly as prescribed.
UK launch of generic lenalidomide for myeloma
Published on 19/01/22 at 09:44am
Accord Healthcare have announced the UK launch of generic lenalidomide, available for the treatment of adult patients with multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, and follicular lymphoma, as either a monotherapy or combination therapy.
Multiple myeloma is a cancer of the plasma cells in bone marrow. This causes bone pain in the chest or spine, fatigue, nausea, constipation, frequent infections, and weight loss. In the early stages, myeloma may not cause any symptoms, and is often only suspected or diagnosed following routine blood or urine tests.
Typical survival of the cancer is seven months without treatment, and four to five years with treatment. There are around 6,000 new myeloma cases in the UK every year, with an increase in incidence rates of a third since the 1990s. Currently, approximately 24,000 people are living with multiple myeloma in the UK.
Accord lenalidomide has been granted Marketing Authorisation by the MHRA, in line with the licensed indications of the brand originator, Revlimid®, and is now available for patients throughout the UK in seven dose strengths ranging from 2.5mg to 25mg.
Lenalidomide is a form of targeted therapy called an angiogenesis inhibitor, and a cancer growth inhibitor. It is also a type of immunotherapy called an immune system modulator. Lenalidomide treatment interferes with chemicals that use cells to signal to each other to grow, and it affects how the immune system works. It also prevents tumours creating their own blood vessels, which all cancers require in order to develop. Lenalidomide must not be used during pregnancy.
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Lenalidomide Mylan is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Mylan is used:
in adults with previously untreated (newly diagnosed) multiple myeloma, who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor);
in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
in adults whose disease has been treated at least once. It is used in combination with dexamethasone.
In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Mylan is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.
Lenalidomide Mylan contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid.
Because Lenalidomide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Mylan has been shown to have comparable quality and to be bioequivalent to Revlimid. Therefore, the Agency’s view was that, as for Revlimid, the benefits of Lenalidomide Mylan outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Lenalidomide Mylan will provide educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards to patients about the safety measures patients should take.
The company has also set up a pregnancy prevention programme in each member state and will collect information on the medicine’s use outside its approved uses. The boxes containing Lenalidomide Mylan capsules also include a warning stating that lenalidomide can be harmful to the unborn child.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Mylan have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lenalidomide Mylan are continuously monitored. Side effects reported with Lenalidomide Mylan are carefully evaluated and any necessary action taken to protect patients.
The wife is currently taking Mylan (Viatris) Lenalidomide
Last year the wife had had three lumbar punctures to empty 3 litres of fluid a go from her lungs. I had had to call an ambulance in French as her oxygen saturation had dropped below 85%. She came out of hospital on the 21st of December and had started her chemotherapy on the 16th. As soon as they were certain of the diagnosis of multiple Myeloma, the haematologist asked the team and they authorised the very expensive treatment using Daratumumab, Bortezomib and high dose Dexamethasone. The latter became known as Dexy’s Midnight runners or the wide awake club.
We had a hospital bed downstairs and puffing billy, an oxygen concentrator, was running most of the time and all night long. We had puffing billy portable for car and assisted walks around the lake. I was taking oxygen saturation readings on a regular basis.
The wife was still very ill but the chemo was starting to kick in fast. We had an “accidental” blood test two weeks in and the huge monoclonal peak in the electrophoresis had dropped to 40%.
This day one year ago we went to haematology at St Brieuc with puffing billy portable for the Dara and Bortezomib. The French healthcare system was Santa for us. That is a few grands worth of chemo! There was long acting morphine morning and night for the pain. She was a bit out of it most of the time.
I had contacted a few people in case the wife wanted to have last words with them.
Today is near normal. I have just taken her to the GP to have her ear syringed. She has stopped saying, “what?” and I don’t need to call her Jeff.
The mole traps are up. We have a blockage in the pipe to the cess pit. Tomorrow it will be plumber’s rods…shit happens.
This morning as I was collecting the leaves with my new toy, I uncovered the evidence. I present it here my lord. This mole is taking the piss like a professional. He could not have come any closer to the house and my desk. This hill is less than 3 metres from my left elbow.
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Unfortunately, it has signed its own death warrant.
Today we went to Binic near St. Brieuc. The idea is to scout locations closer to the big hospital for when the Myeloma returns. It is very nice. We are considering downsizing. There are loads of quayside restaurants and we had 23˚C on the 29th of October! The clocks go back overnight. Holy cow batman!
Whenever we go near the big “city” we note the relative youth of the cars and the relative expense thereof. Today people sat at the restaurants were smartly dressed and it is clear there is much more money around. Around here the women don’t wear much make up nor dye their hair as much. The average age tends towards the silver-haired, or the not long out of school. You don’t see many 40 somethings with dosh. For the first time in over 3 years, I saw an overtly homosexual male couple promenading. Later I saw a lesbian couple arm in arm. The things they do up there in the big “city”. Why is that male homosexuals tend to take more care in their appearance than straight blokes, whereas lesbians can take less of an interest than their straight counterparts?
Considering I used to count Soho and Compton Street as places I knew like the back of my hand, it is a bit odd that I was surprised at seeing these people going about their business. It is official I have become a bumpkin. Here my combat trousers and lambda particle decay t-shirt draw no attention. In quaint Binic, I saw people looking at my combats. They drive fast and aggressively. They do not say “bonjour” to one and all. I would probably shit myself if I had to drive on the M25 or get on the tube at Oxford Street station.
The old fart status is also proven. I can put my hand on my heart and say that I have never used a sat. nav. I struggle with the Samsung J3 ‘phone and I have not used 1 gigabyte of 4G data on said apparatus. I don’t know who 70% of the people on Strictly are nor what the whiskey foxtrot “love island” is all about. We do have Daft Punk and David Guetta CDs. Is my generation the only one to wear rainbow coloured psylocibin zwitterion and Sex Pistols t-shirts as we approach 60? My lot were before MDMA. We were already old school.
When even the new prime minister looks young…Q.E.D. It is old fart city Arizona…At least Penny Lancaster is not a teenager…
Traou an Dour 
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