Articles tagged with: Velcade
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A new retrospective study by Emory University researchers may stir debate about the best way to treat high-risk myeloma patients.
The researchers investigated treating high-risk myeloma patients for up to three years with a combination of Revlimid, Velcade, and dexamethasone.
The extended three-drug therapy, which the authors describe as a combined consolidation/maintenance regimen, was initiated after the patients had received a stem cell transplant. The patients' transplants were carried out soon after completion of the first (induction) treatment regimen following diagnosis.
Some, but not all, of the patients also received the Revlimid-Velcade-dexamethasone …
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Researchers from the U.S. National Cancer Institute recently initiated a Phase 1 clinical trial that will test whether dinaciclib in combination with Velcade and dexamethasone is safe and effective as an anti-myeloma therapy.
The clinical trial is taking place at a several locations across the United States, and is open to multiple myeloma patients who have relapsed after at least one previous myeloma treatment regimen.
Dinaciclib (SCH727965) is currently being developed by Merck (NYSE: MRK). It is a small molecule that inhibits enzymes called cyclin-dependent kinases, which regulate the cell cycle and are often overactive in cancer cells. Dinaciclib interrupts the cell cycle by inhibiting these kinases, ultimately causing the cell to die.
Preclinical studies have shown that Velcade (bortezomib) is more effective when cyclin-dependent kinases are inhibited, and a previous Phase 1/2 study showed that dinaciclib is safe and active as a monotherapy for relapsed/refractory myeloma (see related Beacon news).
Therefore, this study is being conducted to determine the efficacy and safety of dinaciclib in combination with Velcade and dexamethasone (Decadron).
For more information about the trial, see the trial description at the U.S. clinical trial registry.
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Results of a recent international Phase 3 study demonstrate that the addition of Zolinza to Velcade increases response rates and slightly improves progression-free survival in relapsed and refractory myeloma patients compared to treatment with Velcade alone.
Specifically, 56 percent of patients responded to treatment with Zolinza (vorinostat) plus Velcade (bortezomib) compared to 41 percent of patients treated with Velcade plus placebo.
However, despite improvements in responses, the difference in progression-free survival between the two treatment groups was small. Treatment with Zolinza plus Velcade was associated with a 25-day …
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Patients With Periodontitis May Be At Increased Risk For Developing Osteonecrosis Of The Jaw – Results from a small Australian trial suggest that multiple myeloma patients who receive bisphosphonates and experience periodontitis (inflammation or bleeding in their gums) may be at an increased risk for developing osteonecrosis of the jaw. Osteonecrosis of the jaw is a condition that is associated with a loss of blood supply to the jaw, causing the jawbone tissue to die. It can occur in multiple myeloma patients during treatment with bisphosphonates, such as Aredia (pamidronate) and Zometa (zoledronic acid). Specifically, the researchers found that patients with at least one spot in their gums with periodontitis with a depth greater than 4 mm were at a particularly high risk of developing jawbone disease. For more information, please refer to the study in the Journal of Oral and Maxillofacial Surgery (abstract).
Blood Test May Predict Velcade-Induced Peripheral Neuropathy – Findings from a prospective Japanese trial involving more than 60 patients indicate that a blood test may be able to predict whether a multiple myeloma patient will develop peripheral neuropathy (pain, tingling, and loss of sensation in the extremities) when treated with Velcade (bortezomib). The Japanese researchers took samples of each trial participant's blood before the patients started treatment with Velcade. The cells in the blood samples were then stimulated to see how much they started to produce certain immune system proteins. The investigators found that, when stimulated, the blood from patients who did not develop peripheral neuropathy during Velcade treatment was significantly more likely to start producing the protein interleukin 2 (IL-2) than the blood from patients who developed peripheral neuropathy. IL-2 stimulates the production of certain types of white blood cells, known as lymphocytes, which defend the body against infections and other threats. Based on their results, the researchers recommend that the blood test they used be validated in additional studies with larger numbers of patients. For more information, please refer to the article in the Blood Cancer Journal (full text, open access).
Phase 2 Trial To Study LCL161 In Relapsed and Refractory Multiple Myeloma Patients – The Mayo Clinic will soon be opening for enrollment a Phase 2 trial of the investigational compound LCL161, alone or in combination with cyclophosphamide (Cytoxan), in relapsed and refractory multiple myeloma patients. LCL161, which is being developed by the pharmaceutical company Novartis, works by binding to, and thereby neutralizing, inhibitor apoptosis proteins (IAPs), which shield cancer cells from cell death. The compound is also being investigated as a treatment for a number of different solid-tumor cancers. For more information on the trial, please see the clinical trial description.
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Results from a recent retrospective analysis conducted in Germany indicate that the combination of Velcade plus Treanda and prednisone is effective for relapsed and refractory multiple myeloma patients with kidney impairment.
Specifically, 67 percent of patients responded to the treatment, and kidney function improved in 86 percent of patients. The study investigators point out that the responses were rapid, with a median time to response of three weeks. With a median progression-free survival of 10 months, some patients experienced a long-term treatment-free interval.
Most of the severe side effects of the combination …
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Anti-Cancer Virus May Enhance Efficacy Of Velcade Against Myeloma – Results from a recent preclinical study in myeloma cells show that Velcade (bortezomib) inhibits replication and spread of the anti-cancer vesicular stomatitis virus (VSV). However, when both were administered to mice with multiple myeloma, the combination more effectively killed myeloma cells than either the virus or Velcade alone. The researchers conclude that these latter findings support clinical study of VSV in combination with Velcade for the treatment of myeloma. VSV, which belongs to the same family of viruses as the rabies virus, can infect insects, animals, and humans, causing flu-like illness in humans. VSV also attacks and kills cancer cells. It is currently being studied in a clinical trial for the treatment of liver cancer and in preclinical studies for melanoma, lung cancer, colon cancer, and certain brain tumors. The VSV used in the recent preclinical study was genetically modified to specifically target myeloma cells and to reduce side effects. In addition, a component was added to the virus so that spread of the virus could be monitored. For more information, see the study in Experimental Hematology (abstract).
Preclinical Study Shows BAY80-6946 May Be Effective Against Myeloma – Results from a recent preclinical study show that the compound BAY80-6946 kills multiple myeloma cells. Specifically, BAY80-6946 reduced growth of myeloma cells grown in the laboratory and cells isolated from myeloma patients by up to 50 percent. It also killed 70 percent to 87 percent of myeloma cells in mice with multiple myeloma, without observed side effects. BAY80-6946 is an investigational myeloma treatment being developed by the German pharmaceutical company Bayer. It belong to a class of drugs that block an enzyme in cancer cells known as phosphoinositide 3-kinase (PI3K). By inhibiting PI3K, BAY80-6946 disrupts the cell division cycle and causes cancer cell death. BAY80-6946 is in Phase 1 trials as a potential treatment for a variety of different solid tumors, and it is also in a Phase 2 trial for non-Hodgkin's lymphomas. Perifosine is another investigational drug that belongs to the same class of drugs as BAY80-6946. Perifosine was also being developed for the treatment of multiple myeloma; however, it lacked significant efficacy in a Phase 3 myeloma clinical trial and is no longer being studied. For more information about the BAY80-6946 study, see the related article in Blood Cancer Journal.
More Doxil Shortages Expected – Janssen Products, the manufacturer of Doxil (doxorubicin liposomal), announced in a letter to health care providers at the end of September that the supply of Doxil will be interrupted due to difficulties at their external manufacturer. Janssen expects the shortages to take effect the middle or end of October. Doxil is currently approved in combination with Velcade for previously treated multiple myeloma patients. The company asked physicians not to start any new patients on Doxil until further notice. In the meantime, Janssen is working closely with the U.S. Food and Drug Administration (FDA) to establish other ways to ensure a reliable drug supply. However, a generic version of Doxil is available since receiving FDA approval in February (see related Beacon news). The current Doxil shortage is the second in two years. Doxil was in limited supply from August 2011 to October 2012 due to manufacturing problems (see related Beacon news). For more information about the current shortage, see the Janssen Products announcement (pdf) and a related FDA announcement. Updates on the situation will be available on the Doxil website.
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Final results from a recent Phase 2 clinical trial continue to indicate that panobinostat in combination with Velcade and dexamethasone is effective for heavily pretreated multiple myeloma.
In the study, known as “PANORAMA 2,” patients who had previously relapsed and were no longer responsive to Velcade (bortezomib)-based treatment received panobinostat in combination with Velcade and dexamethasone (Decadron).
The results show that one-third (35 percent) of the patients responded to the treatment, and the median progression-free survival was 5.4 months.
In comparison, myeloma experts found during a prior review of the …