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

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. …

On May 31 at the 45th meeting of the American Society for Clinical Oncology (ASCO), researchers from Italy will report the results for a Phase 3 study currently comparing the combination Velcade (bortezomib)–melphalan (Alkeran)–prednisone–thalidomide (Thalomid) (VMPT) to Velcade-melphalan-prednisone (VMP) for the treatment of elderly, newly diagnosed myeloma patients.

Overall, the very good partial response rate for patients treated with VMPT was 55 percent, compared to 45 percent for those treated with VMP. After a median follow-up time of 14.5 months, the three-year progression-free survival was 74 percent in the …

A recent study in the April issue of Blood compared combination treatment regimens for elderly myeloma patients.

The study found that elderly multiple myeloma patients undergoing treatment with melphalan (Alkeran) and prednisone , known as an MP regimen, enjoyed higher 1-year and overall survival rates than those undergoing treatment with thalidomide (Thalomid) and dexamethasone (Decadron), known as a TD regimen. The combination of thalidomide and dexamethasone resulted in greater tumor reduction, but it did not ultimately translate to better outcome, due to the high rate of fatal toxicities. …