The United States Food and Drug Administration (FDA) has approved changes to the prescribing information for Velcade (bortezomib), including the addition of long-term data from the VISTA trial showing that Velcade extends survival of newly diagnosed multiple myeloma patients. New dose recommendations for patients with moderate to severe liver damage were also added. The changes were approved in response to a supplemental new drug application (sNDA) submitted by Velcade’s manufacturer, Millennium: The Takeda Oncology Company.

The VISTA trial, titled “Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment with

The results from a new study indicate that treatment of newly diagnosed multiple myeloma with novel therapeutic agents improves kidney function in most patients, in comparison to treatment with conventional chemotherapy and a high-dose regimen of dexamethasone (Decadron). The authors of the study presented the results of the clinical trial on December 8 at the 51^st American Society of Hematology (ASH) Annual Meeting and Exposition.

Multiple myeloma patients commonly experience complications with kidney function, and kidney impairment is associated with increased mortality rates. The Myeloma Beacon recently published a series …

A drug combination including Revlimid (lenalidomide) as both an induction and maintenance therapy increases progression-free survival in newly diagnosed multiple myeloma patients over the age of 65 years, new Phase 3 research suggests. Researchers presented the preliminary results of the MM-015 clinical trial on December 7 at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans.

Currently, Revlimid is only approved in combination with dexamethasone (Decadron) to treat relapsed multiple myeloma patients, according to the United States Food and Drug Administration. This trial’s findings …

Results from a new study indicate that, in elderly multiple myeloma patients, a combination drug regimen of Velcade (bortezomib), melphalan (Alkeran), prednisone, and thalidomide (Thalomid) (VMPT), followed by a maintenance regimen of Velcade and thalidomide, is superior to the current standard treatment of Velcade, melphalan, and prednisone (VMP) without a maintenance regimen. The authors of the study will be presenting the results of the Phase 3 clinical trial at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition.

In the study, scientists randomly assigned 511 myeloma …

Elderly people with multiple myeloma have better treatment options now than ten years ago. In the past decade, the introduction of thalidomide (Thalomid), Velcade (bortezomib), and Revlimid (lenalidomide) have improved patients’ response to treatment and increased survival time, even when used without stem cell transplants.

In the July issue of Current Opinion in Hematology, Dr. Donna E. Reece, a physician and researcher at the Princess Margaret Hospital in Toronto, reviewed the current approaches to treating newly diagnosed multiple myeloma patients. Dr. Reece discussed autologous and allogeneic stem cell transplants …

On September 2, Millennium: The Takeda Oncology Company reported that the company’s supplemental new drug application (sNDA) has been accepted for review by the U.S. Food and Drug Administration. The acceptance is based on the long-term overall survival data from the VISTA Phase 3 clinical trial that examined the use of Velcade (bortezomib) for treatment of previously-untreated multiple myeloma.

The VISTA trial compared a drug regimen of Velcade, melphalan (Alkeran), and prednisone with a drug regimen of melphalan and prednisone without Velcade in patients with previously untreated myeloma. …

Phase 2 trials will begin for a new form of melphalan (Alkeran), a form of low-dose chemotherapy for multiple myeloma patients, made by CyDex Pharmaceuticals, Inc. These studies will compare the effectiveness of CyDex’s new melphalan, Propylene Glycol-Free Melphalan HCL (CDX-353), and GlaxoSmithKline’s Alkeran in multiple myeloma patients who will be undergoing stem cell transplants.

According to CyDex’s press release, the advantages of the new treatment are its one-vial packaging, gentler formula, and increased stability at room temperature. “These advantages have the potential to enable doctors to safely achieve a higher …