Friday, October 24, 2008

Barbara Hammack Survivor Story I'M A SURVIVOR!

Editor's note: I have exchanged emails with Barbara, who has agreed to allow Myeloma Atlantic to re-produce her heroic story and Barbara also promises an update on her battle with Multiple Myeloma, one with which we are all too familiar. Therefore, dear readers, expect more from Barbara.

Barbara Hammack
August 2007

Whenever I am privileged to speak to a newly-diagnosed myeloma patient, I always start by saying, "I was diagnosed in 1991." Once they quit gasping, I know I have already given them they hope they need.

Nothing can prepare someone for learning they have an incurable disease, much less one that they had never even heard of. I was first told that I had a "suspicious" high protein level in July 1991. My internist had been following this level since I had become his patient in 1987 (my previous doctor never included protein levels in his blood work for me). Then I heard "smoldering multiple myeloma" for the first time as a "possible" diagnosis. I really didn't understand much then, but the only literature available back in those "dark ages" said that I had a 1 - 3 year survival chance. This was totally unacceptable to me, since I was only 45 and was a single parent to two children. So, in February of 1994 when the myeloma reached a point when it needed to be treated, I knew I was in for the fight of my life.

In 1994, the only chemotherapy regime was melphalan and prednisone. Once that worked, my oncologist said that the only hope for a longer survival would come from a bone marrow transplant, still considered "experimental" by many people, including insurance companies. So I fought my insurer and won THAT battle. When I entered Georgetown University Hospital in Washington DC in November 1994, they advised that I also do a very new component: have my stem cells transplanted as well as my bone marrow. Now, in hindsight, I was truly a pioneer for one of the biggest tools today in the myeloma arsenal. But then, all I cared about was winning my own battle.

Which, at least as of now, I am continuing the good fight. It's been the typical roller coaster that many people use to characterize their experiences with myeloma. My transplant kept me out of trouble until 2001, when I began taking thalidomide. After eight months, my disease was under control, and since I'd started to have some very minor neuropathy, I stopped taking it. Then in September 2003, with some indication of disease progression, I went on a new protocol using melphalan, arsenic trioxide, and ascorbic acid (MAC). Again, this worked quite well and I stopped this combination in June 2004. But, as always is the case with myeloma, I again needed treatment and began taking revlimid/dexamethasone in October 2005.

Up and down; down and up. Revlimid was discontinued in June of 2006, and I went coasting along, with no treatment other than monthly aredia, until just recently. Though my M-spike and IgG are relatively low, these counts have been steadily progressing for several months. My oncologist's strategy with me is to always keep me out of danger, so I will start taking just Revlimid in the next few weeks. He and I agree that this should be the most benign of the plethora of treatment options; knowing that there are so many more tricks to pull of out that great myeloma hat as I need them.

In fact, I'd say that the biggest thing I've been able to appreciate over the years is how much the treatment of myeloma has changed from my first encounter some 16 years ago. My oncologist told me several years ago that every six months of life buys a new treatment, and he is pretty much on target. I've watched that "1 - 3 year survivable" rate extend to the point where NO ONE knows how long myeloma patients will live because we are all just starting to live longer and longer. To look at the "end point" is having tunnel vision, and wasting energy that could be used to, well, just get about one's life.

Of course, life with myeloma isn't the same as life before we ever heard those words. But then again, life is constantly changing, and we are always in flux as we adjust to having a baby, having an empty nest, having a job promotion, deciding to know, all that "normal" stuff. I've learned not to get too far ahead of myself, and to try to remember what TODAY'S problems are, rather than playing the "what if" game. Life does indeed go on...the sun still comes up every day, whether we have myeloma or not. On the mornings when I decide that I might as well get up (is there a choice??) I can usually find something that makes that day worthwhile.

We CAN survive myeloma; some of us for a very long time. I'm all for living with myeloma instead of dying from it. I truly don't know what else to do.

Copyright 2007

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Thursday, October 23, 2008

Phase 2 Study of Patients with Multiple Myeloma

Celgene Corporation and Acceleron Pharma Initiate Phase 2 Study of ACE-011 in Patients with Multiple Myeloma

CAMBRIDGE, Mass. – October 16, 2008 – Celgene Corporation (NASDAQ:CELG) and Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced the initiation of a Phase 2 clinical study of its lead compound ACE-011 in patients with multiple myeloma. ACE-011 is being developed to treat bone loss associated with multiple myeloma and other cancers. The clinical study is designed to assess the safety and efficacy of ACE-011 in multiple myeloma patients with osteolytic bone lesions. Celgene Corporation will make a $5 million milestone payment to Acceleron in accordance with the terms of the collaboration agreement between the two companies.

“We are excited to begin the first ACE-011 Phase 2 study in multiple myeloma patients suffering from cancer-related bone loss,” said Matthew Sherman, M.D., Chief Medical Officer of Acceleron. “We have encouraging results from Phase 1 studies with ACE-011, and believe that it holds promise as a novel bone-forming agent to treat the serious and debilitating effects of bone loss resulting from progression of tumors in myeloma or other cancers. Acceleron plans to present results from the Phase 1 studies at scientific and medical conferences later this year.”

The Phase 2, multi-center, randomized, double-blind, placebo-controlled study is designed to assess the safety and efficacy of multiple doses of ACE-011 in multiple myeloma patients with osteolytic bone lesions. The study will be a multi-center trial conducted in Russia and patients will be treated with standardized anti-myeloma therapy consisting of melphalan, prednisone and thalidomide and randomized to receive either monthly doses of ACE-011 or placebo for up to three months. This study is funded in part by a grant from the Multiple Myeloma Research Foundation.

About ACE-011

ACE-011, a soluble form of the activin receptor type IIA (ActRIIA), is a biologic therapeutic that inhibits signaling through the ActRIIA receptor. By blocking signaling though ActRIIA, ACE-011 stimulates bone formation. In numerous animal models of diseases involving bone loss, ACE-011 significantly increased bone mineral density, improved bone architecture, increased bone formation rate and bone mechanical strength. In Phase 1 clinical studies in healthy volunteers, ACE-011 had an encouraging safety profile, increased biomarkers of bone formation and increased bone mineral density. ACE-011 is being jointly developed by Acceleron and Celgene Corporation for the treatment of cancer-related bone loss.

About Multiple Myeloma and Metastatic Bone Disease

Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. When functioning normally, plasma cells are part of the immune system that helps fight infection and disease. In multiple myeloma, the malignant plasma cells form tumors that affect the function of the bone marrow and cause damage to the surrounding bone. This bone damage leads to severe bone pain and fractures of the bone which are disabling and often require surgery or radiation therapy.

Metastatic bone disease is a serious complication that develops when solid tumors metastasize, or spread, from the originally affected organ to bone. These tumors secrete factors in the bone allowing tumor proliferation and causing debilitating bone lesions. Many patients with breast or lung cancer will have tumors that metastasize to the bone and these patients will suffer from severe bone pain and fractures.

About Celgene/Acceleron Collaboration

On February 20, 2008, under the terms of the agreement, Celgene and Acceleron announced that they will jointly develop, manufacture and commercialize Acceleron’s products for bone loss. Celgene made an upfront payment to Acceleron of $50 million, which included a $5 million equity investment in Acceleron. In addition, in the event of an initial public offering of Acceleron, Celgene will purchase a minimum of $7 million of Acceleron common stock.

Acceleron is responsible for initial activities including research and development through the end of Phase 2a clinical trials as well as manufacturing the clinical supplies for these studies. In turn, Celgene will conduct the Phase 2b and Phase 3 clinical studies and will oversee the manufacture of Phase 3 and commercial supplies. Acceleron will pay a share of the development expenses and is eligible to receive development, regulatory and commercial milestones of up to $510 million for the ACE-011 program and up to an additional $437 million for each of the three discovery stage programs. Both companies will co-promote the products in North America. Acceleron will receive tiered royalties on worldwide net sales.

About Celgene

Celgene Corporation, based in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at

About Acceleron

Acceleron is a privately held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel biotherapeutics that modulate the growth of bone, muscle, fat and the vasculature to treat musculoskeletal, metabolic and cancer-related diseases. Acceleron’s scientific approach takes advantage of its unique insight into the regenerative powers of the Growth and Differentiation Factor (GDF) family of proteins. ACE-011, a novel bone forming agent, is the Company’s lead program and is being developed to reverse bone loss in diseases such as cancer-related bone loss. In addition, the company is advancing through preclinical development product candidates that increase muscle mass, control angiogenesis and inhibit fat accumulation. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company’s internal GMP manufacturing capability to rapidly and efficiently advance its therapeutic programs. The investors in Acceleron are Advanced Technology Ventures, Bessemer Ventures, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For more information, visit


Acceleron Pharma:

Steven Ertel, 617-649-9234 Paul Kidwell (Media)

Vice President, Corporate Development Suda Communications LLC, tel: 617-296-3854

Celgene Corporation:

Greg Geissman, 908-673-9854

Associate Director, Public Relations

NEW ORAL THERAPY FOR blood cancer approved in Canada

Unprecedented Overall Survival Data for Revlimid® gives Renewed Hope to Multiple Myeloma
Patients with Advanced Disease

OAKVILLE, ON – (October 6, 2008) – Health Canada has approved Revlimid® (lenalidomide), a new treatment with proven ability to increase overall survival and slow disease progression, in combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one therapy. Prior to approval, there were few effective, once-daily oral treatment options available for patients with this aggressive blood cancer.

"The clinical data shows that patients treated with Revlimid and dexamethasone have superior response rates and for a longer duration, experience slower progression of disease, and survive longer than we have ever seen before,” said Dr. Darrell White, Hematologist, Nova Scotia Cancer Centre, Dalhousie University. “This Health Canada approval means that we can now treat many more patients with this incurable form of cancer.”

Multiple myeloma (MM) is a rare, progressive and fatal blood cancer with significant morbidity and mortality[i]. Incidence increases with age and median age at diagnosis is between 63 and 70 years of age. Of the estimated 6000 Canadians suffering with the disease, approximately 1000 will die this year and 2000 new patients will be diagnosed at treatment centres across Canada.

“There is no cure for multiple myeloma, but new oral cancer therapies, like Revlimid, are a step towards changing multiple myeloma into a manageable chronic disease and thus improving patient quality of life,” said Dr. White.

“Revlimid, a once-daily pill, is the only treatment that was able to control my cancer after many attempts, including bone marrow transplants,” said Derek Hunter, a multiple myeloma patient from Saint John, New Brunswick who was diagnosed in 2003. “My greatest hope is that other patients will be given the same chance at life by having access to this great treatment.”

The Health Canada approval was based on the results of two Phase III clinical trials, published in the New England Journal of Medicine, evaluating Revlimid with dexamethasone in previously treated multiple myeloma patients which showed an increased overall survival rate and slowed disease progression[ii]. Revlimid will be available in 15 mg and 25 mg oral capsules for the treatment of multiple myeloma after one prior therapy.


REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of-matter and use patents.
About Multiple Myeloma
Multiple myeloma is the second most common blood cancer and represents approximately 1% of all cancers and 2% of all cancer deaths. The Canadian Cancer Society reports that there are about 6000 Canadians living with multiple myeloma, and approximately 2000 new cases are diagnosed each year.[iii]

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.

About Celgene

Celgene Corporation is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at Revlimid is a registered trademark of Celgene Corporation.

Revlimid® was granted the Prix Galien USA 2008 Award for Special Therapeutic Development on September 24, 2008. The Prix Galien Award recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and is considered to be the highest accolade for pharmaceutical research and development.

[i] Canadian Cancer Society/National Cancer Institute of Canada. Canadian Cancer Statistics 2008. Accessed October 1, 2008 at
[ii] New England Journal of Medicine, November 22, 2007
[iii] Canadian Cancer Society. Canadian Cancer Statistics 2008.

Media Contacts:
Tara Knight / Celeste Brown
Hill & Knowlton Canada
(416) 413-4774 / (416) 413-4651 /
MYELOMA CANADA ENDORSES HEALTH CANADA’S APPROVAL OF REVLIMID Revlimid signals new hope for Canadians with bone marrow cancer
Today marked a major step forward for the Canadian myeloma community with Health Canada’s approval of Revlimid in combination with dexamethasone for the treatment of multiple myeloma patients with relapsed or refractory disease.Myeloma Canada issued the following press release endorsing this long-anticipated decision by Health Canada. Attached is the press release issued by Celgene, the manufacturer of Revlimid.Myeloma Canada will continue to monitor further developments as Revlimid makes it way through the Joint Oncology Drug Review (JODR) process. For information on JODR, please click on the following link:

MONTREAL, QC – (October 6, 2008) – Myeloma Canada endorses Health Canada’s decision to approve Revlimid® (lenalidomide), a new treatment for multiple myeloma, clearly demonstrating their commitment to fighting this incurable form of cancer. Revlimid is an oral medication that has demonstrated an ability to extend overall survival of multiple myeloma patients and slow the progression of the disease for patients who have failed other treatments.

“Health Canada’s approval of Revlimid is welcome news for Canadians living with multiple myeloma,” says Myeloma Canada President John Lemieux. “Scientific advances in treatments of blood disorders are helping patients live much longer and have a better quality of life. We are extremely pleased to hear about this approval as it supports doctors in providing the best possible care to all patients.”

About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. The cancer starts in plasma cells, which are made in the bone marrow, and develop into antibodies that help fight infections. In myeloma, abnormal plasma cells, called myeloma cells, grow uncontrollably, crowding out the normal blood cells in the bone. This can bring symptoms such as fatigue, recurrent infections and pain resulting from bone fractures, which disturb the body’s balance of minerals and prevent other organs, such as the kidney and nerves, from working properly. In Canada, approximately 2,000 people are diagnosed with multiple myeloma every year.
Myeloma Canada
Myeloma Canada is a non-profit organization, with registered charity status dedicated to supporting people living with multiple myeloma and is the only national organization exclusively devoted to the Canadian myeloma community. The mission of Myeloma Canada is to: provide educational resources and support to patients, families, and caregivers; increase awareness of the disease; and promote improved access to new therapies, treatment options, and health care resources. Myeloma Canada works with regional support groups and key myeloma experts to strengthen the voice of the Canadian myeloma community. Myeloma Canada works in close affiliation with the International Myeloma Foundation, the world’s oldest and largest myeloma organization. For more information or to find out how you can help please visit our website at
Canada / Myélome Canada
Uniquely devoted to Canada's myeloma communityExclusivement au service de la communauté canadienne du myélome
Mailing Address/Adresse postale:
PO Box / CP 326
Kirkland, QC,
H9H 0A4
(514) 570-9769