Myeloma Canada Annual Conference

Myeloma Canada’s fifth annual Patient, Family & Healthcare Professionals Conference will be held in Calgary on
September 11 & 12 at the Delta Bow Valley Hotel.

LIVING WITH MYELOMA:
Advancing knowledge and wellness through education and empowerment

The year’s Conference, hosted by the Southern Alberta Multiple Myeloma Support Group in co-operation with the International Myeloma Foundation, brings together leading researchers, clinicians and healthcare professionals who will address various aspects of living with myeloma.

The sessions will address the changing approaches to myeloma treatment, the complex decisions that must be made before recommending a treatment and the promising developments that are on the horizon.

Presentations will also be made on how to better cope with unwanted side effects, how to understand your bloodwork and how to manage your lab data.

All of this learning will empower you to help you better manage your myeloma, to have a sense of greater control and, we hope, an improved quality of life.

This year’s panel of experts and topics include:

Brian Durie, MD; Cedars Sinai Cancer Centre, Los Angeles, CA
• Philosophy of “Chronic vs. Cure”: How it Impacts Outcomes
• Myeloma Therapy: Future Directions

Nizar Bahlis, MD; Tom Baker Cancer Centre, Calgary, AB
• Myeloma 101: An Introduction

Donna Reece, MD; Princess Margaret Hospital, Toronto, ON
• Understanding Your Bloodwork
• Current Approaches to Relapsed and Refractory Disease

Morie Gertz, MD; Mayo Clinic, Rochester, MN
• Current Approaches to the Newly-Diagnosed Patient

Arthur Bradwell, MD; University of Birmingham, Birmingham, UK
• Clinical Importance of Serum Free Light Chain Analysis in Myeloma

Teresa Miceli, RN, BSN; Mayo Clinic, Rochester, MN
• Management of Side Effects

Linda Watson, RN, MN, CON (c); Tom Baker Cancer Centre, Calgary, AB
• Living When There Is No Cure

Shane Sinclair, PhD (c); Tom Baker Cancer Centre, Calgary, AB
• Beyond the Blood Counts: Finding Meaning Within a Diagnosis of Myeloma

Additional speakers will address quality of life issues and break out sessions will provide the opportunity to attend presentations of specific interest.

For those attending Friday’s session, there will be a reception and dinner on Friday evening. This will provide attendees with the opportunity to meet and network with other conference participants and medical experts.
REGISTER BEFORE JULY 31 TO TAKE ADVANTAGE OF THE SPECIAL EARLY BIRD REGISTRATION FEE

For full agenda details and online registration, go to the Myeloma Canada website www.myelomacanada.ca and click on 2009 Conference.
http://www.myelomacanada.ca/en/2009_conference.htm

Secure credit card payments can be conveniently made online using PayPal.

To register by mail, please download the registration form from the Myeloma Canada site and mail the completed registration form, along with cheque payable to Myeloma Canada and mail to:

Myeloma Canada Conference Registration
5640 Lodge Crescent SW
Calgary, AB
T3E 5Y7

To register by fax, completed registration forms can be faxed to:
(403) 242-1100

Attendees wishing to stay overnight can take advantage of the special Myeloma Canada room rate of $149.00 at the Delta Bow Valley Hotel.
http://www.deltabowvalley.com/gfamcb911


Myeloma Canada / Myélome Canada
Uniquely devoted to Canada's myeloma community
Exclusivement au service de la communauté canadienne du myélome

Mailing Address/Adresse postale:
PO Box / CP 326
Kirkland, QC
H9H 0A4

(514) 570-9769
Email/Courriel: info@myelomacanada.ca
Web: www.myelomacanada.ca

Ottawa seizing Mexican Thalidomide

First the medical isotope fiasco, now this!?

Canadian patients 'starting to die,' drug firm says

Cancer patients desperate enough to order cheaper, unlicensed versions of the drug thalidomide from Mexico now face another challenge to getting treatment: Federal authorities have reportedly begun seizing supplies of the life-extending medicine at the border.

"Health Canada is stopping every single box of thalidomide," said an official with a Mexican company that makes the pills, who asked not to be named. "Patients are starting to die because of this."

Patient advocates said they had also heard reports that Health Canada and the Canada Border Services Agency have instituted a crackdown on shipments of thalidomide from Mexico and other developing countries.

Health Canada officials would not comment directly on whether they had stepped up seizures, but said their policy has always been to bar unsanctioned imports of such drugs into the country.

The development has nevertheless heightened calls on provincial governments to reimburse the steep costs of the one permitted brand of thalidomide and a similar, newer drug, both of which can add years to the lives of people with multiple myeloma, a rare blood cancer.

Some Ontario patients are even thinking of moving to British Columbia, the one province that covers the newer medicine, said Lori Borsos, a myeloma sufferer in Hamilton.

"If you need this drug to stay alive and you can't afford it, what's your choice?: move to B. C. or move six feet under," she said.

"We all live in Canada and some of us have better health care than others. It's not right."

Thalidomide -- infamous as a morning-sickness remedy that caused widespread birth defects in the 1950s and 1960s -- has proven to be one of the most effective myeloma treatments, but its cost is not officially picked up by any province.

Revlimid, a new drug that acts in a similar way and can cost $100,000 a year, is covered only in British Columbia. Velcade, the other medication widely used by myeloma patients, is financed to at least some extent by most provinces, but is not suitable for all patients.

Private insurance and manufacturers provide some funding, too.

The "core" issue is that provincial governments should pay for all three drugs, said John Lemieux, president of the Myeloma Canada support group. "The patients ... are the sole victims" of the current patchwork of funding policies, he said.

The North American-patented version of thalidomide, made by Celgene Corp. of New Jersey, can cost $40,000 a year, though the firm says it provides it free to about 60% of patients prescribed the medicine. Myeloma Canada says it has been unable to confirm that figure.

Regardless, the rest must either pay out of their own pockets, go without and face shortened lifespans or order versions made in Mexico, Brazil or elsewhere in the developing world.

The cost of one Mexican brand is about one-twentieth of Celgene's. The firm says approximately 100 Canadians have bought thalidomide from it, while other patients have sought supplies from as far afield as India.

Days after a National Post article revealed patients were importing the medicine from overseas, however, Canadian authorities began seizing Mexican shipments of the drug, the pharmaceutical company official said.

Mr. Lemieux said in an e-mailed response that his group has heard reports of as many as 20 patients having their shipments seized, but could not confirm them.

"If they don't have this drug, they will die," said the Mexican company official of her customers.

Some doctors have warned that patients risk consuming substandard product if they order thalidomide from such manufacturers, whichcurrently face no scrutiny from regulators here. Others physicians, though, say the Mexican drug seems to be just as effective and safe as the Celgene product, called Thalomid.

Thalomid is not licensed in Canada, but can be legally ordered by doctors under Health Canada's special-access program, designed to make treatments not yet approved here available on an emergency basis.

It was allowed under the program partly because Celgene, the manufacturer, has an extensive program for dealing with the drug's infamous side effects, Health Canada said in an e-mailed statement. Celgene only provides a month's supply at a time, and requires doctors to submit negative pregnancy tests for female patients of child-bearing age before dispensing more pills, the regulator said.

"Health Canada believes that this care and caution is both necessary and appropriate and is commensurate with the risks associated with the drug," the statement said.

A request for the Mexican thalidomide was made under the special-access program a few years ago, but its maker had no such program in place, the department said.

Source: http://www.nationalpost.com/news/story.html?id=1696051

Proteolix Clinical Data from Two Clinical Studies of Carfilzomib in Multiple Myeloma

Proteolix, Inc. announced data from ongoing Phase 2 and Phase 1b clinical trials of carfilzomib for the treatment of multiple myeloma at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany. Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors being developed by Proteolix for the treatment of hematologic malignancies and solid tumors.

Relapsed Multiple Myeloma Patients Achieve Responses with Single-Agent Carfilzomib

Keith Stewart, M.B., Ch.B., Professor, Division of Hematology/Oncology at the Mayo Clinic, Arizona presented positive data from an ongoing Phase 2 clinical trial of single-agent carfilzomib in relapsed multiple myeloma patients. Patients in the study have relapsed after receiving one to three prior therapies and are stratified according to prior exposure to bortezomib.

A total of 31 patients have been enrolled in the Phase 2 clinical trial to date, of which 45 percent had no prior bortezomib experience and 55 percent relapsed following bortezomib treatment. In both arms, substantial response rates were achieved and sustained. Bortezomib-naive patients achieved an overall response rate of 57 percent with a median duration of response of 8.5 months. The median time to progression in this cohort has not been reached.

Among patients with prior bortezomib exposure, 18 percent achieved partial responses and the median duration of response has not yet been reached in this population. The median time to progression for patients in this cohort was 8.9 months. Ten additional patients achieved stable disease.

"Carfilzomib monotherapy achieves durable responses in relapsed multiple myeloma patients regardless of their prior exposure to bortezomib, and notably, a number of patients remain progression free after twelve cycles," said Dr. Stewart. "Further, carfilzomib has been generally well tolerated, and the compound's selectivity appears to avoid the off-target effects, such as peripheral neuropathy, associated with currently available proteasome inhibitors."

Adverse events were generally mild and manageable and carfilzomib has been well tolerated for up to one year. Of 31 patients treated, 29 percent have received 12 full cycles of treatment.

These data were reported by Dr. Stewart in an oral presentation, titled "# 0474: Safety and Efficacy Update of PX-171-004, an Open-label Phase II Trial of Carfilzomib in Relapsed Multiple Myeloma," on Saturday, June 6, 2009.

Carfilzomib Combination with Lenalidomide is Well-Tolerated; Achieves Responses in Heavily Pre-treated Patients at Low Doses

Positive preliminary data from an ongoing Phase 1b dose-escalating trial of carfilzomib in combination with lenalidomide
and low-dose dexamethasone in relapsed and refractory patients was presented by Michael Wang, M.D., of the University of Texas MD Anderson Cancer Center on Sunday, June 7, 2009. The Phase 1b clinical trial is designed to evaluate safety and to establish a maximum-tolerated dose of carfilzomib in combination with lenalidomide and dexamethasone administered on a 28-day treatment cycle. Lenalidomide in combination with dexamethasone is currently indicated for use in patients with multiple myeloma who have had at least one prior therapy.

To date, the combination of carfilzomib and lenalidomide was well tolerated in heavily pre-treated patients and adverse events were manageable. The most common adverse events reported include anemia and fatigue. No cases of peripheral neuropathy, a common adverse event associated with approved proteasome inhibitors, have been reported. A maximum-tolerated dose has not yet been established and dose-escalation in this trial continues.

Sixty-one percent of the 18 patients evaluable for efficacy achieved very good partial, partial or minor responses. Responses occurred in the first 28-day cycle of treatment at doses well below the maximum-tolerated dose for either lenalidomide or carfilzomib alone. Initial responses improved with continued therapy. Potent inhibition of the proteasome has been observed and the lenalidomide/dexamethasone combination does not appear to interfere with carfilzomib's activity.

"Results observed to date in our Phase 1b combination study of carfilzomib are very promising," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer of Proteolix. "We believe that carfilzomib in combination with lenalidomide and dexamethasone should provide superior activity to lenalidomide and dexamethasone alone. In addition, the lack of overlapping toxicities and absence of peripheral neuropathy may allow for long-term dosing - and ultimately, sustained clinical benefit."

Dr. Wang presented interim data from the Phase 1b clinical trial during the Novel Therapeutics and Drug Resistance session in an oral talk, titled "#1070: PX-171-006: Phase IB Multicenter Dose Escalation Study of Carfilzomib (CFZ) plus Lenalidomide (LEN) and Low Dose Dexamethasone (LODEX) in Relapsed and Refractory Multiple Myeloma (MM) - Preliminary Results."

About Carfilzomib

Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors. Carfilzomib produces specific and sustained inhibition of the proteasome, leading to apoptosis in cancer cells with minimal off-target effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated single-agent activity in hematologic malignancies and solid tumors, including multiple myeloma, Waldenstrom's macroglobulinemia, mantle cell lymphoma and renal cell carcinoma.

Proteolix is conducting a comprehensive clinical development program evaluating carfilzomib for the treatment of multiple myeloma, including an ongoing accelerated approval study in heavily pre-treated relapsed/refractory patients and a Phase 2 clinical trial in relapsed patients stratified by prior treatment with bortezomib. Both Phase 2 clinical trials are being conducted by Proteolix in collaboration with the Multiple Myeloma Research Consortium (MMRC). A Phase Ib clinical trial of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma is also ongoing. In addition, Proteolix is conducting a single-agent Phase 2 clinical trial of carfilzomib in patients with recurrent or advanced solid tumors. For the latest information regarding ongoing carfilzomib clinical trials, please visit www.clinicaltrials.gov.

About Proteolix

Founded in December 2003, Proteolix, Inc. is a privately-held biotechnology company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing novel therapeutics that target protein degradation pathways for cancer and autoimmune diseases. Proteolix's lead product, carfilzomib, is the first in a new class of selective, irreversible proteasome inhibitors. Proteolix is also developing a pipeline of novel proteasome inhibitors, including a selective, oral proteasome inhibitor and a selective immunoproteasome inhibitor. For additional information on Proteolix, please visit www.proteolix.com.

Revlamid Presentations at the 14th Congress of the European Hematology Association

Celgene announced that data from multiple studies presented at the 14th Congress of the European Society of Hematology demonstrate that REVLIMID provides powerful and sustained responses in patients with multiple myeloma. These key presentations support the advantage of active long-term disease control along with manageable safety profiles, leading to unprecedented survival times.

"Together, the studies presented at this congress demonstrate that the use of REVLIMID early on in the course of the disease allows for rapid and durable responses that lead to the best survival benefits we've seen yet for this patient population," said Jean-Pierre Bizzari, Senior Vice President and Group Head of Global Oncology/Hematology for Celgene. "We are excited that the dual mode of action of REVLIMID, which includes both a direct killing effect against myeloma cells and a unique immune-enhancing effect, controls and manages the disease over the long-term."

Speed of response with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma: First results of the MM-019 German compassionate use protocol

Treatment time required for patients with multiple myeloma to respond to therapy with REVLIMID plus dexamethasone was examined in a phase IIIb, open-label, non-comparative trial. Patients had received at least one previous therapy and were treated in 28-day courses that were repeated until disease progression, toxicity or withdrawal by the physician or patient.
Patients' previous therapies, including transplantations, bortezomib and thalidomide, did not influence response rates. Fifteen patients (12%) had been previously treated with all three regimens, 43 (35%) with two and 42 (34%) with one.
Best response information, measured by levels of M protein and free light chains (FLC), was available for 113 patients, including four patients with a complete response, 80 with a partial response, 28 with stable disease and one with disease progression.

Time to a 50 percent reduction in M-protein or FLC was analysed for 122 patients. For responding patients, median time to response was 28 days, with 39 percent of patients seeing a response in two weeks.

"These data demonstrate that nearly three-quarters of patients achieved a partial response or better, despite having been heavily pretreated," said Dr. Katja Weisel of University Hospital in Tubingen, Germany. "The responses were rapid, with half of the patients responding well within the first treatment course."

Longer duration of treatment and maintenance of best response with lenalidomide plus dexamethasone increases overall survival (OS) in patients with relapsed/refractory multiple myeloma

A subset analysis of updated, pooled data from the MM-009/MM-010 international phase III trials demonstrated a survival benefit upon continued treatment with REVLIMID(R) plus dexamethasone after achieving best clinical response in patients with relapsed or refractory multiple myeloma.

Survival estimates for patients achieving a partial response or better were compared between patients on continuous treatment (those still undergoing treatment or who discontinued due to disease progression) and patients who discontinued treatment early due to adverse events, consent withdrawal or other reasons. Median follow-up time for surviving patients was 48 months.

The estimated median survival time for patients continuing treatment after achieving a partial response or better (N=174) was 50.9 months [95% confidence interval: 43.0-NR], while the median survival time for those who discontinued treatment early (N=38) was 34.95 months [26.4-55.7; P=0.0594].

When differences in the groups' patient characteristics (such as age, number of prior treatments, etc.) were also taken into account, the group that continued treatment had significantly better survival outcomes than did the group that discontinued therapy.

The number of patients who discontinued early due to adverse events was low (N=22, 10%).

"This study suggests that therapy with REVLIMID plus dexamethasone should be prolonged even after the patient achieves an initial response," concluded Dr. Jesus San Miguel of the University Hospital of Salamanca in Salamanca, Spain. "The lasting effects gained by additional rounds of treatment may significantly prolong survival for these patients."

Lenalidomide-based therapy leads to improvement in humoral immune system in relapsed or refractory multiple myeloma patients who respond to the therapy

Dr. Rachid Baz of the Moffitt Cancer Center & Research Institute, in Tampa, FL, USA presented another analysis of MM-009/MM-010, as well as of a large phase II study of REVLIMID(R) as a single agent therapy in patients with relapsed or refractory multiple myeloma, demonstrated that REVLIMID therapy improves patient immunity by boosting immunoglobulin A (IgA) levels.

Levels of IgA, an important antibody for fighting infections, are commonly reduced in patients with multiple myeloma. These low levels are associated with recurrent bacterial infections - the most common cause of death for patients in advanced stages of the disease.

The study measured baseline levels of the antibodies and evaluated antibody responses to therapy on a monthly basis. Improvement was defined as an increase in antibody levels to at least the lower limit of normal and a 25 percent increase in value.

Only patients who responded to therapy showed significant improvement and normalisation of residual IgA levels. At baseline, residual IgA levels were normal in 30 and 17 percent of responders in MM-009/MM-010 and MM-014, respectively. With treatment, normalised IgA levels were found in 56 percent of responders in MM-009/MM-010 by cycle seven and in 50 percent of responders in MM-014 by cycle five.

Patients whose IgA levels normalised had significantly longer progression-free (29-77 weeks) and overall (121-220 weeks) survival times compared to those whose IgA levels did not improve (P=0.0001).

Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma

Also of note is a study that was recently published in the European Journal of Hematology. This subset analysis of MM-009/MM-010 demonstrated the benefit of initiating REVLIMID plus dexamethasone at first relapse compared to later salvage therapy.

The study showed that, with REVLIMID plus dexamethasone, patients who had received one prior therapy demonstrated significant improvements compared to those who had received two or more prior therapies in outcomes such as median time to disease progression (17.1 vs. 10.6 months; P=0.026), median progression-free survival (14.2 vs. 9.5 months; P=0.047), complete or very good partial responses (39.8% vs. 27.7%; P=0.025) and median overall survival (42.0 vs. 35.8 months; P=0.041).

"These results suggest that it may be beneficial to patients to be treated with REVLIMID plus dexamethasone earlier on in the treatment course," said Dr. Edward A. Staudtmauer of the Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. "Based on the findings, the combination of REVLIMID and dexamethasone should be considered as a second-line therapy for patients with multiple myeloma."

REVLIMID is approved in the United States, the European Union, Canada, Argentina, Peru, Bolivia, Columbia, Guatemala, Switzerland, Malaysia, Israel, Singapore and Russia in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia and New Zealand in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy.

Prunes Promote Bone and Heart Health

Better Heart and Bones with This Sweet Snack

Looking to satisfy your candy cravings with something tasty and good for you? Try a handful of nature’s guilt-free treats: dried plums. Research shows that they promote both heart and bone health.

Buff Bones

A laboratory study of the polyphenols in prunes showed that they boosted bone formation, density, and strength. How? By affecting the way certain bone-regulating gene cells are expressed.

A Plum Choice for Your Heart

Results from animal studies suggest that dried plums can help keep arteries clear. Researchers suspect that prune flavonoids help reduce the inflammation that plays a big role in artery disease.

Big Benefits, Little Package

If that isn’t enough motivation to pick up a pack of prunes, consider this: Just 10 prunes delivers 20 percent of your daily potassium and copper requirements, 14 percent of your iron requirements, and 10 percent of your manganese and zinc requirements. Prunes also provide a whopping dose of the essential vitamins A, C, E, and B-complex, including folate. And we all know that prunes are a super source of fiber.

Do prunes conjure up a vision of your grandma saying something about regularity? Meet today’s marketing replacement the dried plum! Full of antioxidants, dried plums (okay . . . prunes) are a delicious and sweet treat.

Source: http://www.realage.com/ct/eat-smart/food-and-nutrition/tip/8787