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

If the FDA approves pomalidomide based on this application, Celgene could begin marketing pomalidomide in the United States as early as this fall.

Pomalidomide, which belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lenalidomide), is being developed by Celgene (NASDAQ: CELG) for the treatment of multiple myeloma and myelofibrosis.…

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The results of an Italian Phase 3 study show that consolidation therapy with a combination of Velcade, thalidomide, and dexamethasone is more effective in newly diagnosed multiple myeloma patients than treatment with thalidomide and dexamethasone alone.

Specifically, the three-drug regimen led to higher rates of complete responses, as well as longer progression-free survival, compared to the two-drug regimen.

“Analyses performed in our study demonstrate that VTD [Velcade-thalidomide-dexamethasone] consolidation therapy significantly contributed to improved clinical outcomes,” said lead study investigator Dr. Michele Cavo from the Seragnoli Institute of Hematology in Bologna,…

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We do not choose chronic illness – it chooses us. Being tapped on the shoulder by multiple myeloma is an invitation into a deeper experience of life, whether we like it or not.

Expressive writing is a useful practice for mining the depths of what is inside. Support groups frequently draw upon writing exercises, and studies have found that writing actually promotes true healing.

For those who want to use writing practice for self-discovery, I recommend a simple exercise beginning with the phrase “I remember.”

I remember pink and black…

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Progression From MGUS To Myeloma Is Similar Among Japanese And Westerners – A recent study found that Japanese people with monoclonal gammopathy of undetermined significance (MGUS) progressed to multiple myeloma at rates similar to those previously reported for Westerners.  Specifically, the results showed that 3 percent progressed within 5 years, 9 percent within 10 years, 11.4 percent within 15 years, and 32.1 percent within 20 years.  For more information, see the study in the journal Rinsho Ketsueki (abstract).

Pomalidomide May Be Effective In Patients With Amyloidosis – Results from a Phase 2 study show that pomalidomide plus dexamethasone (Decadron), a combination being studied for the treatment of multiple myeloma, may also be effective in previously treated patients with immunoglobulin light chain amyloidosis.  Amyloidosis is a blood disorder that results in the abnormal accumulation of proteins in tissues and organs throughout the body.  An estimated 10 percent to 15 percent of myeloma patients also develop symptoms associated with amyloidosis (see related Beacon news).  Among the 33 amyloidosis patients included in the study, 48 percent had improved blood cell counts and 15 percent had organ improvement after treatment with pomalidomide and dexamethasone.  The median progression-free survival was 14 months, and the median overall survival was 28 months.  For more information, see the study in the journal Blood (abstract).

Participants Needed For Myeloma Risk Association Study – The International Myeloma Foundation is conducting a study to determine why certain races and family members are at an increased risk of developing multiple myeloma.  The study is a brief survey that multiple myeloma patients can complete via the Internet.  To participate, see the study website.

Clinical Insights Education Program – The Multiple Myeloma Research Foundation (MMRF) is sponsoring an education program for myeloma patients and their families about multiple myeloma clinical insights. The event will be held on April 27 in New York City. Myeloma experts from leading cancer centers will speak about the latest advances in frontline therapy, stem cell transplants, relapsed and refractory myeloma, supportive care, and clinical trials. A question and answer session is included in the program. Registration will begin at 9 a.m., and the program will conclude at 2:30 p.m. For more information or to register, please see the MMRF website.

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

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A recent study suggests that Mozobil helps multiple myeloma patients with prior exposure to Revlimid collect enough stem cells for transplantation.

The study investigators conclude that stem cell mobilization with the aid of a growth factor plus Mozobil (plerixafor) is an effective upfront approach for multiple myeloma patients who plan to undergo a transplant, regardless of previous Revlimid (lenalidomide) exposure.

“With growth factor and preemptive Mozobil, virtually all patients with multiple myeloma can have successful stem cell collection,” said Dr. Luciano Jose Costa of the Medical University of South…