Myeloma + Treatment = Chance of Secondary Cancer–> o joy!!!

Revlimid Prescribing Information Updated To Include Secondary Cancer Warning

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Published: Mar 15, 2012 3:43 pm; Updated: March 15, 2012 11:30 pm

The U.S. Food and Drug Administration has added a warning to the prescribing information for Revlimid stating that patients being treated with the drug have an increased risk of developing a second cancer.
The warning has been added in two parts of the prescribing information.
In the upfront ‘Warnings and Precautions’ section, text has been included stating that “Higher incidences of SPM [second primary malignancies] were observed in controlled trials of patients with multiple myeloma receiving Revlimid.”
Later in the document, the warning is expanded to explain that studies have shown that multiple myeloma patients treated with Revlimid (lenalidomide) as well as melphalan (Alkeran) and stem cell transplantation were more likely to develop a second cancer than those receiving comparable treatment without Revlimid.  In particular, the Revlimid-treated patients were at higher risk of developing acute myelogenous leukemia and Hodgkin’s lymphoma.
The Food and Drug Administration (FDA) recommends in the prescribing information that physicians monitor patients being treated with Revlimid for the development of second cancers and take into account both the potential benefit of the drug and the risk of second cancers when considering treatment with Revlimid.
Revlimid is marketed by the U.S. pharmaceutical company Celgene (NASDAQ: CELG).
Concerns about a potential Revlimid-secondary cancer link first emerged at the American Society of Hematology annual meeting in December 2010, when results were presented from three trials that showed higher rates of reported second cancers among myeloma patients treated long-term with Revlimid therapy compared to other patients in the same studies.
Despite extensive follow-up research and investigation, concerns about Revlimid and secondary cancer persist. They are reflected, for example, in the recent International Myeloma Working Group consensus statement on maintenance therapy, which cites the risk of secondary cancer in its discussion of maintenance therapy with Revlimid (see related Beacon news).
The recent change in the U.S prescribing information for Revlimid was preceded earlier this year by a change in the European prescribing information for the drug.  The European change reflects the results of a safety review by the European Medicines Agency, which was concluded last September (see related Beaconnews).
The warning added to the European prescribing information is more extensive than the warning added by the FDA.  In particular, the European agency added three paragraphs to the section on “other special warnings and precautions for use.”
The first two paragraphs note that, in both previously treated as well as newly diagnosed multiple myeloma patients, treatment with Revlimid has been associated with a three- to four-fold increase in the rate of second cancers versus what was observed in the trial control groups.
The third paragraph then states, “The risk of occurrence of [second cancers] must be taken into account before initiating treatment with Revlimid.  Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.”
The U.S. Food and Drug Administration began its own safety investigation of Revlimid – and alsothalidomide (Thalomid), which is chemically similar to Revlimid – in April 2011.  An FDA representative contacted by The Beacon was unable at this time to clarify whether the recent change in Revlimid’s prescribing information reflects the conclusion of the agency’s investigation.
Neither the FDA nor European authorities have thus far made any changes to the prescribing information for Thalomid related to secondary cancers.
At the 2011 American Society of Hematology meeting this past December, Dr. Antonio Palumbo of the University of Torino in Italy summarized results of a retrospective analysis of the risk of secondary cancer associated with Revlimid and thalidomide treatment (see related Beacon news).
The results of the analysis indicate that treatment with Revlimid in and of itself may not increase the risk of secondary cancers.
Instead, there may be an interaction between treatment with melphalan and treatment with Revlimid (or thalidomide) that increases a patient’s risk of developing secondary cancers.
Dr. Palumbo also presented data showing that the risk of developing secondary cancers when treated with Revlimid is generally lower than the risk of a number of serious side effects that can occur during common myeloma treatment regimens.
For more information, see the text that was added to the U.S. and European prescribing information for Revlimid, which is included below, or the full U.S. prescribing information and the full European prescribing information.
Additionally, please see the complete compilation of Beacon articles with information on the Revlimid safety controversy.
Addition To The U.S. Prescribing Information For Revlimid
Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with multiple myeloma receiving Revlimid.
Patients with multiple myeloma treated with lenalidomide [Revlimid] in studies including melphalan and stem cell transplantation had a higher incidence of second primary malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin lymphoma, compared to patients in the control arms who received similar therapy but did not receive lenalidomide. Monitor patients for the development of second malignancies.  Take into account both the potential benefit of lenalidomide and the risk of second primary malignancies when considering treatment with lenalidomide.
Addition To The European Prescribing Information For Revlimid
An increase of second primary malignancies (SPM) has been observed in clinical trials in previously treated myeloma patients receiving lenalidomide [Revlimid] / dexamethasone (3.98 per 100 patient-years) compared to controls (1.38 per 100 patient-years). Non invasive SPM comprise basal cell or squamous cell skin cancers. Most of the invasive SPMs were solid tumour malignancies.
In clinical trials of newly diagnosed multiple myeloma, a 4-fold increased incidence of second primary malignancies has been observed in patients receiving Revlimid (7.0%) compared with controls (1.8%). Among invasive SPMs, cases of AML [acute myeloid leukemia], MDS [myelodysplastic syndromes] and solid tumours were observed in patients receiving Revlimid in combination with melphalan or immediately following high dose melphalan and ASCT [autologous stem cell transplant]; cases of B-cell malignancies (including Hodgkin’s lymphoma) were observed in the clinical trials where patients received Revlimid in the post ASCT setting.
The risk of occurrence of SPM must be taken into account before initiating treatment with Revlimid. Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.

Great Myeloma article on trying to find our “new normal” 

http://www.myelomabeacon.com/resources/

http://www.myelomabeacon.com/blog-posts/

http://www.myelomabeacon.com/links/

I’m LEARNING that I TRIED TOO HARD TOO SOON TO BE TOO NORMAL…
headed to the Cardiologist tomorrow… I can’t get rid of these chest pains, breathlessness and sometimes stabbing/jabbing chest pains ….

Too Many, Too Much, Too Overwhelming

I’d like to write another “happy” post like my last one, but I am just overwhelmed by so many people in my life with medical challenges:

A dear family friend (who’s like a brother to Jim and me, and another dad to Scott and Alissa) recently suddenly, …

Remission = Back in the Saddle again!

July 4, 2010 =Receiving Myeloma killing Melphalan Chemo
at City of Hope Hospital
July 5, 2010 =
Receiving my life regenerating Stem Cells
at City of Hope Hospital

February 4, 2012 =Back in the Saddle again
for the first time since 2009!

Mom and Daug…

December + Biopsies = Cancer

Friends are advising us to stay away from Doctors around New Years and head to Hawaii, staying as far away from medical facilities as possible— and here’s why:

December 2009 = Bone Marrow Biopsy for me
December 2011 = Cystourethroscopy for my …

Diagnosis: Multiple Myeloma – 12 – 30 – 2009

December 30, 2009 my life forever changed
December 30, 2009 I was diagnosed with Multiple Myeloma CANCER

That day, that appointment, is still a blur… except for the word cancer, cancer, cancer
Multiple Myeloma Cancer invaded my body and consumed …

2 years ago today, my life as I knew it, began to change forever

12 – 14 – 2009 …  2011
Two years ago today I had my FIRST evaluative appointment in a department called… “HEMATOLOGY-ONCOLOGY”

I was smart enough to know what those terms TECHNICALLY meant by definition … but I was not at all connecting the significance to me!
I arrived at Kaiser check-in for this appointment (that, bad me, I had put off for a month!), and was quite surprised to see the word ONCOLOGY connected on the sign to HEMATOLOGY!
W H A T ??? Huh? Seriously people, I’m in the WRONG department!

Honestly, I was aware there was “something” going on with me and my blood… but I took a casual, over-confident attitude about it
Fortunately, my very diligent GP had called several times the previous month, advising me that “something” was seriously wrong with my blood levels.
He advised me that I needed additional blood work and I needed to be on Iron immediately, as I was dangerously anemic
He referred me to a HEMATOLOGIST fast!

Ha! I thought… nothing’s REALLY WRONG with me… I’m OK!
I’m just a little bit tired (lie!)
I’m doing too much, for too many (understatement!)
Random intense headaches (I never had headaches before)
Just a little bit dizzy (scary dizzy sometimes!)
Just a little bit low on iron (very low!)
Just a little bit anemic (very anemic!)
Just losing blood everyday from various areas:
Nose bleeds = Allergies I thought (daily nose bleeds… a lot!)
Mid-life female bleeding issues = normal I thought (a lot! = not normal)
Just a bit thinner than usual, but enjoying that (true enough!)
Feeling faint sometimes (scary, passing out faint!)
Feeling dehydrated all the time (weird feelings with this)
Exhausted and fatigued – I’m just doing too much (way too much!)
I rationalized it all… (O yes I did, dumb me!)

I checked in… lightheartedly…
Jim and I moved towards the waiting area…
I noticed that several patients in the waiting area looked sickly, sort of “cancerous”… their color was off, and several had scarves or hats on, or VERY short hair-
Geeezzzz, I thought, I certainly don’t belong in this department as I comforted myself and Jim with the thought that Hematology was on ONE SIDE of the department and Oncology would be ON THE OTHER SIDE, of course detached from where we were headed…
Wrong… NOT!!!

I don’t remember many details from this appointment and the appointments thereafter
It was a blur then and still is..
But I do recall everyone seemed to be in a bit of panic over my situation, and I just knew I was fine…

I met my wonderful RN Jalee and my amazing doctor, Dr Lee, that fateful day
Vitals were taken
Previous blood tests were explained and analyzed
Questions were asked
And I was sent immediately to take more blood tests…
STAT!

So much is a blur from that point on
More blood tests, questions and assessments
More concern that I should be hospitalized immediately as several blood levels were DANGEROUSLY LOW or HIGH
Ok, I’ll eat better I rationalized
I’ll hydrate more… make better blood I thought…
Jim’s in a bit of a panic
I’m thinking about being on Winter Break and enjoying the holidays, Dang it!

4 days later, calls from Nurse Jalee and Dr Lee needing to see me for an “emergency” appointment
12 – 18 – 2009
My blood levels are not good
Platelets are dangerously low
My white count is way down
Something about Calcium and Protein levels too high

Jim and Alissa go with me as earlier Alissa needed xrays for a sprained foot
They’re asked to leave the room…
I knew things were getting serious

Surprise—– I’m quickly prepped for a Bone Marrow Biopsy
I’m realizing there’s something kinda serious going on with me
During the very painful biopsy I suddenly become emotional, begin to cry
I’m realizing that I can’t joke about this anymore
I’m a sick lil puppy…
Why else would they need this intense type of assessment
What’s all this mean?
I thank Jalee and Dr Lee for taking such good care of me

It was late, cold and drizzly when we drove home
My thoughts spinning
My world was changing fast
How indeed it was, I would soon find out…

A day before New Year’s, 12- 30- 2009
I was due to return for THE RESULTS…

To Be Continued…

There I am… late 2009
Possessed by (67%) Myeloma
So completely unaware

11 – 11 – 11 A Tribute to Heroes and Warriors

Another November day of ones! Hoping the symbolism means we’ve all won one, won some battle, won remission and we’re number one!
And one day, cancer will not have won!

11 – 11 – 11, a day of celebration of all our Veteran heroes being #1
I thank…

11 – 1 – 11 ~ Cancer is still # 1 ~ but hasn’t won!

Yes, #1 rules the day today!
Who was it that said 1 “is a lonely number”?

Hello November 2011
Where’d October 2011 go so fast?

October’s are COMPLICATED…
October’s represent so many milestones in my life… good and bad.

Two years ago October 2009, I took some VERY important BLOOD tests…
Their IMPORTANCE so unknown to me at that time!
Those October 2009 blood tests SCREAMED something was WRONG with me, but I really didn’t listen well
Those October 2009 blood tests eventually opened the diagnosis-window to the invasion of Myeloma

This October 2011 was a month of continuing to try to move forward in my “New Normal”…
But WHAM!, slap me in the face BAM!… cancer comes to me in multiple reminders!!!

October 2011 seemed to bring more Cancer diagnoses:
My beautiful doggie Molly, my students, colleagues, close friends, neighbors, and new Myeloma sisters from across the country and the globe.

Goodbye October
Hello November

Here’s a tribute to October’s moments:

Remembering then:
October 2010
Buzzzzzz time !!
Thank you my son Scott for a great boy-cut
I still laugh when I remember you buzzing me
and I wanted to retain my “bangs”.. hahaha!!

Reclaiming now:
October 2011
New October, New Hair, New Plan:
Born Blonde, gonna Dye / Die Blonde!! lol
Goldilocks is coming back… well… in short form
(Lousy pic of me, sporting the the Revlimid chemo tired look!)
Reinventing todays:
Bring on the Blonde!
Back to being me… (well almost, ha!)
Celebrating Jill’s superstar success !!
Representing love:
Our beautiful shelter-rescue Molly
Born in October 2002
Diagnosed October 2011 with bone/sinus cancer
(the black doggie here, not you, daughter Alissa!)

Beautiful Barbara
My new Myeloma girlfriend (and her husband Rich)
from Alabama
Thank you Myeloma for introducing us!!!
Celebrating Remission
(Debbie, me and Jim)
Thank you Debbie and Cameron for your $upport!
Thank you COC Nursing Students
for selecting me as your 2011
Ultimate fighters!
SuperStar Supporters
Brian (right) and Shaheen (left)
His courage, strength, determination, and bravery
leaves me in the dust!
And so….
I thank all of you for your support, love, encouragement, humor and friendship!
I dedicate this 11 – 1 – 11 “blog of oneness” to all of you currently battling this mysterious evil invader into our lives called Cancer.
I am thinking about all of you who have battled, fought and lost
I am thinking about all of you who have battled, fought, dominated and WON!
And I am thinking about all of US who are still battling, fighting, kicking and screaming and not willing to let Cancer win…
So on this day of 11 – 1 -11 … we’re #1 :)
Cheers to Chemo Cycle #13 Post Stem Cell Transplant
Go Revlimid Chemotherapy stomping and chomping on Myeloma cells!
Raising my glass of water, downing my pill and toasting to Life and continued Remission!!!
———————————–
Just saw this!!!
What???!!! I should’a partied more!!!
Read on:

Presenting My Story- and Thanking all my Colleagues!

Thank YOU from my heart and soul- to all my colleagues, friends, family and Chancellor Dr Dianne Van Hook for attending my presentation today.
Words always seem so inadequate when trying to express my sincere appreciation for the support you have given me…
I wish there had been more time, for more detail, but hopefully what I shared was meaningful, interesting and helpful.

Just having you there, meant the world to me!
Just knowing you care, gives me courage!
Just knowing you…  invigorates me!

~ Thank you to each and every one of you, from every department that attended- I am so very honored!
~ Thank you Chancellor Dr Dianne Van Hook for attending AND honoring me with your nomination for the SMO Empowering Hearts award! Thank you for your special thoughts, humbling comments and beautiful rose bouquet!
~ Thank you Keitha for coming and representing the Nursing Program students and honoring me with representing your Leukemia, Lymphoma Society’s Light the Night Walk fundraiser!

~ Thank you Professor Mike for bringing your VERY BRAVE and so ADORABLE son Daniel, who is currently battling Acute Lymphoblastic Leukemia, and enduring very intense chemo treatments!

Brave Daniel and supportive sister Caitlin
hamming it for the camera on a clinic day!
Thanks for coming to my presentation Daniel :)

~ Thank you Professor Kelly for organizing, publicizing and participating in my presentation, not to mention your Scientific/Biological Brilliance!
~ Thank you RTVF-Media-Film students for filming my presentation!

~ SERIOUSLY… THANK YOU EVERYONE FOR YOU, YOUR PRESENCE, YOUR SUPPORT, ENCOURAGEMENT AND INTEREST.  I am so humbled and honored…
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Coffee on the Side is an academic seminar series which is offered once a month during the Fall and Spring semesters. The goal is to promote interdisciplinary discussions and continual learning for faculty and staff of College of the Canyons. COTS seminars are organized by the Interdisciplinary Committee.

Sept 2011
How Cancer Stole My Life: Diagnosis, Chemo, a Stem Cell Transplant and My New Normal
Presented by Julie Visner, Counseling Department

Come hear Counselor Julie Visner’s personal story of her sudden and surprising (incurable) cancer diagnosis, chemo treatments and stem cell transplant adventure all resulting in remission, along with her personal reflections on going from presumed health to a near death diagnosis. Julie will share medical details, personal reflections and answer your questions about this life-altering experience.

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Aug 2011
Stem Cell Therapies: Controversies and Cures
Presented by Kelly Cude, Biology Department

What are stem cells? Will stem cells help paralyzed people walk again? Are stem cells the key to curing terminal diseases like Parkinson’s disease and cancer? If so, why is stem cell research so controversial? In this month’s FLEX presentation, we will discuss the current and future uses of stem cell therapies.

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Please support COC’s Nursing Students cancer fundraiser:
Leukemia Lymphoma Society’s SCV Light The Night Walk, Fundraiser

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Myeloma Details website