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Thursday, March 15, 2012

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 ....


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My Story... How my MM was diagnosed

October/November/December 2009...

Most of my life I was VERY presumptuous about being healthy, taking my (mostly) GOOD health for granted...
I was committed to annual check-ups for all of us, and so late October 2009, my daughter and I went for our annual and very routine physicals.

Surprise, surprise... my routine blood tests revealed extreme Anemia, significant White and Red Cell issues, low Platelets, and a variety of other CBC red flags! I was (stupidly) not worried when my GP doc left repeated phone messages to contact him, and when we did speak, I (stupidly) requested postponement of his referral appointment to the Hematology Dept until the end of the Fall academic term.

Arriving for my first appointment Dec 14, 2009, I was confronted with the check-in sign that read: "Hematology/Oncology"... What? Nooooo! not me... I must be in the WRONG place! And so my diagnosis journey began with vials and vials of blood drawn "stat", urgent Dr consultations, a surprise and painful Bone Marrow Biopsy, a full body Skeletal Scan, more blood tests stat, and then on 12.30.2009... THE revealing meeting... the "huh-what" moment ... the confirmation diagnosis that I, Julie, have CANCER!!!

Happy New Year to me, I just learned a new vocabulary word:
Multiple Myeloma!!! MM, Multiple Mye-what-loma!!!

January - June 2010

My medical metamorphosis began.
I read, and read, and read and researched and researched MM. I trusted my expert Oncology/Hematology team's plan and began my "New Normal" as a cancer patient.
My treatment plan was developed to include powerful Dexemthesone steroids paired with Revlimid chemotherapy, with the plan to be hospitalized for an Autologous Stem Cell Transplant July 2010.

I began living "one day at a time" like never before.
Jim was a wreck. Alissa and Scott were stunned; family and friends shocked.

Me... Cowgirl Up! I got back in the saddle and knew I was in for the ride of my life!
I did well on my initial pill-form Revlimid Chemo, "roid-rage" Dex Steroids and other supportive meds. I am forever deeply grateful and appreciative for all the love and support from everyone in my personal and professional life! I thank all of you for working along with me, and allowing me to continue to lead a semi "normal" life!
YOU have helped save my life!

My treatment trail ride forks to City of Hope hospital as I will saddle up beginning June 9, 2010 for a new rodeo called an Autologous Stem Cell Transplant!
Ye-Ha, let the adventure begin!

Chemical Warfare...

January 2010 - May 2010:
My initial chemo regimen:

Pill form Chemo= Revlimid (10mg, 15mg capsules)
Pill form Dexamethasone Steroids (40 mg, 4 days on, 4 days off!
Omeprazole for steroid acid reflux
Mepron (looks like yellow finger paint) Anti-fungal, Anti-viral, etc for my very compromised immune system
B-12
.81 Aspirin to prevent DVT, Revlimid complications
Allopurinol- keeping the kidneys healthy
Acyclovir- anti-Shingles, anti-viral

June 2010:
High dose IV Cytoxan chemo
Neupogen to build up stem cells for Apheresis, stem cell harvest, which was very successful, as City of Hope was able to collect 9.5 million of my own stem cells

July 2010 Hospitalization:
Two days of high dose Melphalan chemo
Then July 5, 2010 = my Autologous Stem Cell transplant infusion!

And you can read my whole story from that point forward in this blog!


What is multiple myeloma?

What is multiple myeloma?

Cancer starts when cells in the body begin to grow out of control. Cells in nearly any part of the body can become cancer, and can spread to other areas of the body. To learn more about how cancers start and spread, see What Is Cancer?

Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system.

The immune system is made up of several types of cells that work together to fight infections and other diseases. Lymphocytes (lymph cells) are the main cell type of the immune system. The major types of lymphocytes are T cells and B cells.

When B cells respond to an infection, they mature and change into plasma cells. Plasma cells make the antibodies (also called immunoglobulins) that help the body attack and kill germs. Lymphocytes are in many areas of the body, such as lymph nodes, the bone marrow, the intestines, and the bloodstream. Plasma cells, however, are mainly found in the bone marrow. Bone marrow is the soft tissue inside some hollow bones. In addition to plasma cells, normal bone marrow has cells that make the different normal blood cells.

When plasma cells become cancerous and grow out of control, they can produce a tumor called a plasmacytoma. These tumors generally develop in a bone, but they are also rarely found in other tissues. If someone has only a single plasma cell tumor, the disease is called an isolated (or solitary) plasmacytoma. If someone has more than one plasmacytoma, they have multiple myeloma.

Multiple myeloma is characterized by several features, including:

Low blood counts

In multiple myeloma, the overgrowth of plasma cells in the bone marrow can crowd out normal blood-forming cells, leading to low blood counts. This can cause anemia – a shortage of red blood cells. People with anemia become pale, weak, and fatigued. Multiple myeloma can also cause the level of platelets in the blood to become low (called thrombocytopenia). This can lead to increased bleeding and bruising. Another condition that can develop is leukopenia – a shortage of normal white blood cells. This can lead to problems fighting infections.

Bone and calcium problems

Myeloma cells also interfere with cells that help keep the bones strong. Bones are constantly being remade to keep them strong. Two major kinds of bone cells normally work together to keep bones healthy and strong. The cells that lay down new bone are called osteoblasts. The cells that break down old bone are called osteoclasts. Myeloma cells make a substance that tells the osteoclasts to speed up dissolving the bone. Since the osteoblasts do not get a signal to put down new bone, old bone is broken down without new bone to replace it. This makes the bones weak and they break easily. Fractured bones are a major problem in people with myeloma. This increase in bone break-down can also raise calcium levels in the blood. (Problems caused by high calcium levels are discussed in the section “How is multiple myeloma diagnosed?”)

Infections

Abnormal plasma cells do not protect the body from infections. As mentioned before, normal plasma cells produce antibodies that attack germs. For example, if you developed pneumonia, normal plasma cells would produce antibodies aimed at the specific bacteria that were causing the illness. These antibodies help the body attack and kill the bacteria. In multiple myeloma, the myeloma cells crowd out the normal plasma cells, so that antibodies to fight the infection can’t be made. The antibody made by the myeloma cells does not help fight infections. That’s because the myeloma cells are just many copies of the same plasma cell – all making copies of the same exact (or monoclonal) antibody.

Kidney problems

The antibody made by myeloma cells can harm the kidneys. This can lead to kidney damage and even kidney failure.