Levact Receives Positive Opinion In Europe For Myeloma – On March 19, Mundipharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Levact (bendamustine) for patients with multiple myeloma, indolent non-Hodgkin’s lymphoma (NHL), and chronic lymphocytic leukemia (CLL). The drug is currently approved in the United States for CCL and NHL under the brand name Treanda. For more information, please see the Mundipharma press release.

Millenium Holds Web Cast About mymultiplemyeloma.com – On March 24 at 1 p.m. EST, Millennium Pharmaceuticals, the manufacturer of Velcade (bortezomib), will be hosting a Web cast on its soon-to-be-launched educational Web site mymultiplemyeloma.com. The Web cast will include presentations by an advanced practice nurse, an oncology social worker, and a myeloma patient. Registration is requested by calling (866) 508-6181.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

Myeloma Awareness Month Teleconference Series – Each Friday during the month of March, the International Myeloma Foundation (IMF) will be hosting a teleconference to raise awareness and provide up-to-date information about multiple myeloma. The teleconferences are scheduled for 7 p.m. EST and will include a 60 minute presentation followed by a 30 minute Q&A. Patients, family members, caregivers, and health care professionals are welcome to join. Please see the IMF Web site for more information.

NCI Designs MGUS/Smoldering Myeloma Study – Researchers from the National Cancer Institute (NCI) are in the process of developing a prospective study with the goal of identifying causes of transformation from monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (both asymptomatic, pre-malignant disorders) to multiple myeloma. The study will enroll 350 patients with MGUS or smoldering myeloma in the United States and follow them for up to five years. For more information, please contact the research nurse for this study, Mary Ann Yancey, at (301) 435-9227 or yanceym@mail.nih.gov.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

MMRC Honors Dana-Farber Cancer Institute With 2009 Center Of The Year Award – The Multiple Myeloma Research Consortium (MMRC) awarded its 2009 Center of the Year Award to the Dana-Farber Cancer Institute for its excellence in the number of clinical trials launched, the speed at which they were opened, and the number of patients enrolled in the trials. The Award will be accompanied by a one-year grant to fund a multiple myeloma clinical trial project coordinator at Dana-Farber. For more information, please see the MMRC press release.

Volunteer At 2010 Walt Disney World Marathon Weekend – The 2010 Walt Disney World Marathon Weekend will take place January 7 through 10. Events include the Walt Disney World Marathon and Half Marathon, Goofy’s Race and a Half Challenge, Disney/Pixar UP & Away Family Fun Run 5K, Mickey’s Marathon Kids’ Fest and Mickey Mile, and Disney’s Health & Fitness Expo. The Marathon Weekend will benefit the Leukemia & Lymphoma Society. Registration to participate in the events is almost full, but volunteers are still needed to provide assistance during the weekend. For more information, please see the Disney World Sports Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

About The H1N1 Flu

The H1N1 flu, also referred to as “swine flu,” has caused thousands of hospitalizations and more than 600 deaths in the United States since it was first detected in April 2009.

It is spread through person-to-person contact, often by sneezing or coughing, similar to transmission of the seasonal flu virus. Symptoms of the H1N1 flu and the seasonal flu both include a cough, sore throat, runny nose, body aches, headache, chills, tiredness, and sometimes fever, vomiting, and diarrhea.

H1N1 Vaccine Recommendations

The H1N1 vaccine is recommended for the general population, but especially for those at high risk for flu complications. The Centers for Disease Control and Prevention (CDC) has issued a list of high-risk groups. Myeloma patients are included in two of the high-risk groups: those with blood disorders and those with cancer.

The H1N1 flu vaccine comes in two forms – flu shot and nasal spray. The flu shot is an inactivated vaccine, which means that it contains killed virus; it is given with a needle and is approved for healthy individuals as well as those with chronic medical conditions. The nasal spray is made with live, weakened viruses that do not cause the flu and is not recommended for immunocompromised individuals.

Multiple myeloma patients are generally advised to get the H1N1 and seasonal flu vaccine shots as soon as possible. The H1N1 shot and the seasonal flu shot can be administered on the same day, and vaccinations will be offered throughout the influenza season, which can extend as long as April or May.

The United States Food and Drug Administration has reported that one dose of the H1N1 vaccine is necessary to achieve immunity in adults. It takes two weeks for the vaccine to create immunity within the body, but protection lasts up to a year.

However, the vaccine may have lower effectiveness in people 65 and older, as well as those with chronic medical conditions.

Dr. William Bensinger, a myeloma specialist at the University of Washington and Fred Hutchinson Cancer Research Center in Seattle, said in an email to The Myeloma Beacon, “It should be recognized that some myeloma patients will not develop immunity to the vaccine due to impaired humoral [blood-related] responses associated with myeloma.”

Dr. Bensinger recommends that patients who have recently undergone stem cell transplantation should wait at least six months before getting the vaccine.

“I definitely recommend the killed vaccine to all family members; this will help prevent flu transmission to patients,” Bensinger added.

Myeloma patients and families who have experienced flu-like symptoms since the spring of 2009 should still be vaccinated against H1N1.

Myeloma patients and families who received the 1976 swine influenza vaccine are recommended to also receive the 2009 H1N1 vaccine. The difference between the two viruses is significant enough that the 1976 vaccine will not likely protect against H1N1.

October presented limited amounts of the H1N1 vaccine. However, 38 million doses are currently available, and 8 million more are expected next week.

Due to the limited availability of the H1N1 vaccine, certain groups have been given priority over others to receive it. Among those given priority are people ages 25 through 64 years of age with chronic health disorders or compromised immune systems, including multiple myeloma patients. So far, families of myeloma patients are not part of this priority group.

Safety And Side Effects Of The H1N1 Vaccine

Side effects for the flu shot include soreness, redness, or swelling around the area of the injection; low grade fever; and aches. Side effects for the nasal spray in adults include runny nose, headache, sore throat, and cough; children may experience runny nose, wheezing, headache, vomiting, muscle aches, and fever. There are no side effects that are specific to myeloma patients.

People who are allergic to eggs may be allergic to the influenza vaccines and should speak with a doctor or medical professional before considering whether to get the H1N1 or seasonal flu vaccines.

Independent health advisers recently began monitoring the safety of the 2009 H1N1 vaccine. As of yet, no concerns have been reported.

Government officials, including Health and Human Services Secretary Kathleen Sebelius, and the CDC have spoken out against rumors that the 2009 H1N1 vaccine was not adequately tested. Tom Skinner, spokesperson for the CDC, said that the H1N1 vaccine was created using the same process as the seasonal flu vaccine, which has a “very, very good track record as far as safety is concerned.” The World Health Organization has also spoken out against claims that skipping the seasonal flu virus decreases the risk of contracting the H1N1 virus.

Preventing H1N1 Infection

Even if a myeloma patient gets the H1N1 vaccine, he or she should continue taking all necessary precautions to prevent infection, since the vaccine may not be as effective in people with compromised immune systems.

Family members of all myeloma patients are advised to get the killed vaccine to prevent flu transmission to patients.

Everyone, but especially myeloma patients who are not recommended to get the H1N1 vaccine, should follow CDC precautions: wash hands thoroughly and often; cover mouth and nose with a tissue when coughing or sneezing; avoid touching eyes, nose, and mouth; stay home from work or school if sick; and avoid others who are experiencing H1N1 symptoms. Myeloma patients should also consider wearing a face mask when in crowded public places or while traveling.

Treating H1N1 Infection

A specific test is needed to determine H1N1 infection. If a myeloma patient develops H1N1 or the seasonal flu, their doctor may advise the patient to take an antiviral drug, either Relenza (zanamivir) or Tamiflu (oseltamivir).

Antiviral drugs are prescription medications that stop flu viruses from reproducing inside the body. These drugs can make illness milder, lead to quicker recovery, and may prevent serious flu complications. Antiviral drugs should be taken within 48 hours or as soon as possible after symptoms begin for maximum effectiveness.

For more information about the H1N1 vaccine, please see the CDC Web site and previous Myeloma Beacon coverage of the H1N1 vaccine.

Similar to Velcade (bortezomib), carfilzomib is a proteasome inhibitor that blocks the activity of these protein-destroying enzymes and induces cancer cell death. Carfilzomib is currently undergoing Phase 2 trials on patients with relapsed multiple myeloma, for which data will be reported in late 2010. Phase 3 trials combining carfilzomib with Revlimid (lenalidomide) and dexamethasone (Decadron) will begin next year. Carfilzomib is also undergoing early-stage clinical trials for solid tumor cancers.

“There is a tremendous need for new agents in multiple myeloma that can extend and improve the lives of patients and be used in combination with existing therapies,” said Todd Yancey, vice president of clinical development at Onyx.

Onyx could potentially pay up to an additional $535 million to cover development of carfilzomib, including $170 million for accelerated approval by the U.S. Food and Drug Administration. Onyx expects to expand its research and development budget to continue the development of carfilzomib.

For more information about Onyx’s purchase plan, please read the Onyx press release. For information about carfilzomib clinical trials, please see The Myeloma Beacon research summary about carfilzomib’s Phase 1 trial results or the National Institutes of Health’s directory of ongoing carfilzomib clinical trials.