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Onyx Pharmaceuticals announced this morning that it has completed submission of its application to the U.S. Food and Drug Administration (FDA) for the approval of carfilzomib (Kyprolis) as a treat­ment for re­lapsed and refractory multiple myeloma.

Onyx began submitting the application in January after the FDA granted car­filz­o­mib "Fast Track" status, which expedites the review process by allowing the submission of application materials on a rolling basis.  The com­pany has requested priority review of the car­filz­o­mib application, which, if granted by the FDA, could allow the drug to be launched in the …

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Reduced-Dose Velcade-Thalidomide-Dexamethasone Is Effective For Newly Diagnosed Myeloma – Recently published results from a French study show that the com­bi­na­tion of reduced-dose Velcade (bor­tez­o­mib) and thalidomide (Thalomid) plus dexamethasone (Decadron) is safer and more effective than standard-dose Velcade plus dexa­meth­a­sone for the treat­ment of newly diagnosed multiple myeloma patients. The results were pre­vi­ously presented at the American Society of Clinical Oncology (ASCO) meeting in June 2010. Results showed that after four cycles of ther­apy, patients who received the reduced-dose three-drug com­bi­na­tion had a significantly higher response rate and experienced fewer side effects than patients receiving the standard-dose regi­men. The same group of patients con­tinued to have a higher response rate after stem cell trans­planta­tion. For a more detailed summary of the results, please see the Beacon’s coverage of the ASCO presentation or the study in the journal Blood (abstract).

Phase 3 Clinical Trial Investigating The Need For Stem Cell Transplantation Is Recruiting Myeloma Patients – Newly diagnosed multiple myeloma patients under the age of 65 years are being recruited at various cancer centers across the United States for a Phase 3 clinical trial that will in­ves­ti­gate whether stem cell trans­plants are necessary in the era of novel agents.  All participants will be treated with a com­bi­na­tion of Revlimid (lena­lido­mide), Velcade, and dexa­meth­a­sone.  Half of the patients will then also receive a stem cell trans­plant.  Based on the results, researchers will determine whether stem cell trans­planta­tion sig­nificantly extends pro­gres­sion-free survival. For more in­­for­ma­tion or to enroll, please see the clinical trial description.

Teleconference On Clinical Trial Participation – On Thursday, the Inter­na­tional Myeloma Foundation will sponsor a teleconference about the importance of participating in clinical trials.  Dr. Brian Durie, a myeloma specialist at Cedars-Sinai Cancer Center, will discuss the Phase 3 clinical trial comparing carfilzomib-Revlimid-dexamethasone and Revlimid-dexamethasone alone.  The call will be held from 4 p.m. to 5 p.m. PT.  For more in­­for­ma­tion, please see the International Myeloma Foundation website.

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

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Protein May Interfere With Revlimid Doses In The Body – Results of a recent small Phase 1 clinical trial investigating the efficacy and safety of Revlimid (lena­lido­mide) in com­bi­na­tion with Torisel (temsirolimus) suggest that P-glycoprotein, a protein that causes the removal of certain drugs from cells into the bloodstream, interferes with Revlimid dosing. High levels of P-glycoprotein in cancer cells may be the cause of drug resistance. The researchers observed higher than expected concentrations of Revlimid in the patients’ bloodstreams. Experiments in the lab showed that P-glycoprotein removed Revlimid from the cancer cells. The experiments also showed that the rate of removal was lower when Torisel was added to the experiments, which, according to the study authors, is evidence that the two drugs inter­act via P-glycoprotein. For more in­­for­ma­tion, please see the study in the Journal of Clinical Oncology (abstract) or the Ohio State University Medical Center press release.

Phase 2 Trial Of Carfilzomib For Multiple Myeloma Is Recruiting Patients – The Multiple Myeloma Clinical Research Section at the National Cancer Institute is recruiting participants for a Phase 2 trial to test the effectiveness of the investigational drug carfilzomib in com­bi­na­tion with Revlimid and dexamethasone (Decadron) in newly-diagnosed multiple myeloma patients. Patients will receive eight 28-day treat­ment cycles. Those who show at least stable disease after the treat­ment may con­tinue to receive 12 cycles of low-dose Revlimid main­te­nance ther­apy. In addi­tion to current standard, clinical methods for determining responses to the drugs, the researchers will use new molecular methods to assess response and to detect minimal residual disease. To par­tic­i­pate in the trial, please contact the research nurse, Mary Ann Yancey, at (301) 435-9227 or .

Chicago Area Workshop For Multiple Myeloma Patients – The Multiple Myeloma Research Foundation will hold a one-day educational workshop for myeloma patients and their family members on August 20 in Oak Brook, IL. The pro­gram will be led by Dr. Todd Zimmerman, a myeloma expert from the University of Chicago Medical Center. Throughout the day, myeloma experts will talk about treat­ments options for newly diagnosed and re­lapsed/refractory patients, including stem cell trans­plants, supportive care options, and clinical trials.  The specialists will also be available to answer questions.  Registration will begin at 9 a.m., and the pro­gram will last from 10 a.m. until 3:30 p.m. at the Hamburger University at the Hyatt Lodge. For more in­­for­ma­tion or to register, please see the Multiple Myeloma Research Foundation website. 

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

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Dr. Ken Shain Joins The Beacon's Medical Advisor Team – Dr. Ken Shain, an assistant professor of hema­to­logic malignancies at the H. Lee Moffitt Cancer Center in Tampa, FL, has joined The Myeloma Beacon's team of Medical Advisors.  Beacon Medical Advisors assist with answering medical questions posted in the Beacon’s multiple myeloma forums.  For more in­­for­ma­tion about getting medical questions answered in the forums, please see these instructions.

Onyx And MMRF Offer Carfilzomib Expanded Access Program For Myeloma Patients – Onyx Pharmaceuticals and the Multiple Myeloma Research Foundation (MMRF) announced last week that they have created the Carfilzomib Myeloma Access Program (C-MAP), which will make carfilzomib available to re­lapsed/refractory multiple myeloma patients in the United States who do not have any treat­ment alter­na­tives. Carfilzomib is cur­rently being in­ves­ti­gated as a treat­ment for multiple myeloma. The drug is not yet approved for use in the U.S.; however, under its expanded access pro­gram, the U.S. Food and Drug Administration allows ill patients who lack any other treat­ment options to try a promising drug that is still under devel­op­ment. For more in­­for­ma­tion, please see the Onyx C-MAP website.

Janssen Launches Physician Access Program For Doxil – Janssen Products, the manu­­fac­­turer of Doxil (doxorubicin liposomal), announced on Friday that, in response to a temporary shortage of Doxil, the com­pany has established the Doxil C.A.R.E.S. Physician Access Program.  This pro­gram will allocate any newly available Doxil supply to physicians who are treating patients cur­rently on the drug. The goal of the pro­gram is to ensure that patients cur­rently on Doxil receive their medication.  Janssen announced manu­fac­tur­ing delays last month that resulted in a temporary shortage of the drug. Doxil is cur­rently approved in com­bi­na­tion with Velcade (bor­tez­o­mib) for pre­vi­ously treated multiple myeloma patients. For more in­­for­ma­tion, please see the Doxil website.

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MDX-1097 Receives Orphan Drug Status For Multiple Myeloma – The Australian bio-therapeutic com­pany Immune System Therapeutics announced last week that it has received orphan drug designation from the United States Food and Drug Administration (FDA) for its investigational drug MDX-1097. MDX-1097 is an anti­body that binds to certain proteins on the surface of myeloma cells, triggering the immune system to kill the cancer cells. The FDA uses the orphan drug designation to promote the devel­op­ment of new treat­ments for rare diseases that affect fewer than 200,000 individuals in the United States. The orphan drug status provides the developer of the drug with several benefits, including funding for clinical trials and marketing exclusivity for up to seven years.  For more in­­for­ma­tion, please see the Immune System Therapeutics press release.

MD Anderson Cancer Center Announces Start Of Phase 1 Trial With Carfilzomib Plus Panobinostat In Myeloma – The MD Anderson Cancer Center announced last week that it will be starting a Phase 1 trial in early August to determine the highest tolerable dose levels of carfilzomib in com­bi­na­tion with panobinostat (Farydak) in re­lapsed and refractory multiple myeloma patients. The safety of the com­bi­na­tion treat­ment will also be assessed. Carfilzomib, which belongs to the same class of drugs as Velcade (bor­tez­o­mib), is a new drug from Onyx Pharmaceuticals that is cur­rently being in­ves­ti­gated as a potential treat­ment for multiple myeloma. Panobinostat is an oral experimental cancer drug that is being developed by Novartis. For more in­­for­ma­tion, please see the clinical trial description.

Music Against Myeloma – On Wednesday, July 13, several bands will play at Greenhouse in Manhattan to raise awareness and funds for multiple myeloma. The event starts at 8 p.m. and will feature live bands, drink specials, cupcakes, and more.  All proceeds will go to the Inter­na­tional Myeloma Foundation. For more in­­for­ma­tion and tickets, please see the Music Against Myeloma website.

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

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[ by Julie Shilane | Jun 8, 2011 6:13 pm | Comments Off ]

Monday was the fourth day of the American Society of Clinical Oncology (ASCO 2011) annual meeting in Chicago.  Although the meeting concluded yes­ter­day, Monday was the last day of the meeting that con­tained any myeloma-relevant ma­teri­al.

The morn­ing started with a session recapping highlights of the meeting from Sunday.  Dr. Ivan Borello from the Johns Hopkins Uni­ver­sity School of Medicine was invited to give a 15-minute pre­sen­ta­tion recapping the myeloma highlights (see Part 1 and Part 2 of The Beacon’s Day Three up­date for more in­­for­ma­tion).

The rest of the …

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[ by Julie Shilane | Jun 4, 2011 4:09 pm | 2 Comments ]

This year’s American Society of Clinical Oncology (ASCO) annual meeting, which began on Friday and goes through Tuesday, is being held in Chicago.

On the first day of the meeting, there was only one talk related to multiple myeloma.  During an afternoon education session, in which current practice and recent research results are reviewed, Dr. Raphael Fonseca from the Mayo Clinic in Scottsdale, Arizona, spoke about high-risk multiple myeloma.

The second day of the meeting included a morning and an afternoon session in which myeloma researchers presented their findings in the form …