Velcade is part of a class of cancer drugs called proteasome inhibitors. When Velcade was introduced in 2003, it was the first treatment in more than a decade approved for patients with multiple myeloma.

In the United States, Velcade is approved for the treatment of patients with relapsed or refractory multiple myeloma and is being studied as a treatment for newly diagnosed or untreated patients. Velcade is also approved for use in myeloma in over 85 countries worldwide.

Velcade is made by Millennium Pharmaceuticals. It is also called bortezomib. Velcade is also approved for use in the United States for the treatment of another type of cancer known as mantle cell lymphoma.

In the United States, Velcade is approved for the treatment of patients with relapsed and refractory multiple myeloma who have received one prior therapy. Data from a number of clinical trials have demonstrated Velcade's efficacy in delaying disease progression, achieving high response rates, and improving overall survival in patients with relapsed and refractory myeloma. Velcade has also been show to be highly effective in heavily pretreated patients, in retreating patients, and at a lower dose of 1.0 mg/m² (versus 1.3 mg/m²).

Based on its success in treating patients with relapsed and refractory myeloma, Velcade is now being studied in several clinical trials as a treatment option for newly diagnosed or untreated patients. Data from some of these studies show consistently high response rates, including some of the highest recorded response rates for upfront treatment of myeloma.

In the European Union and many other countries, Velcade is approved for the treatment of patients who have already been treated with one other therapy and who have already had a stem cell transplant or patients who are not eligible for stem cell transplants.

Velcade is a type of cancer drug called a proteasome inhibitor. Proteasomes are enzymes found in cells and play an important role in regulating cell function and growth. Velcade blocks the activity of proteasomes. By blocking the proteasome, Velcade disrupts processes related to the growth and survival of cancer cells.

New data also suggest that Velcade may improve bone disease in myeloma patients. Velcade's beneficial effect on bone disease appears to be independent of whether or not a patient's myeloma responds to Velcade.

Velcade is given by injection (1.3 mg/m²/dose administered) into the bloodstream twice a week for 2 weeks, followed by a 10-day rest period. This is called a treatment cycle. Typically, a total of eight cycles of Velcade therapy are administered. Doses are typically given on Monday and Thursday or Tuesday and Friday.

For more than eight cycles, Velcade may be given on this same schedule as mentioned above or on a maintenance schedule. If you are being given Velcade on a maintenance schedule, you will receive one injection a week for 4 weeks, followed by a 13-day rest period. If you are taking Velcade as part of a clinical trial, you may receive a different dose and follow a different schedule.

The length of treatment with Velcade may be different from patient to patient and is based on how well the drug is working and if the side effects are manageable. In clinical trials, patients were able to receive Velcade for up to eight cycles; patients who were still benefiting were allowed to continue for additional cycles, including maintenance treatment.

If you develop serious side effects, your doctor will most likely reduce your dose or temporarily stop treatment with Velcade. Once the side effects are resolved or treated, Velcade can usually then be started again at a 25% reduced dose (i.e., if a patient had been receiving Velcade at 1.3 mg/m² it should be restarted at 1.0 mg/m²; if receiving 1.0 mg/m², Velcade should be restarted at 0.7 mg/m².) Specific recommendations for management of peripheral neuropathy can be found in the next section.

In the largest study of Velcade to date, known as the Phase III APEX (Assessment of Proteasome Inhibition for Extending Remissions), most of the side effects seen were mild (Grade 1) or moderate (Grade 2) in severity. (Click here to view details.) These side effects can often be managed with other medications, increasing the amount of fluid you drink, reducing the dose of Velcade, or stopping Velcade treatment temporarily until symptoms resolve. The most common side effects seen with Velcade therapy include:

• Tiredness or weakness
• Nausea, vomiting, diarrhea, constipation
• Trouble sleeping or anxiety
• Fever
• Burning or tingling in the hands or feet, a condition known as peripheral neuropathy

Sometimes these symptoms worsen and become serious, so it is important to talk with your doctor if you are having any side effects.

In the APEX study, 75% of patients had serious (Grade 3) or very serious (Grade 4) side effects. If you experience any of the following, tell your doctor immediately:

• Unusual bruising or bleeding, nosebleeds, tiny red spots on the skin, or black, bloody or tarry stools. These may be signs of thrombocytopenia, a serious condition caused by a decrease in the number of platelets
• New or worsening nerve problems, such as a burning sensation, numbness, increased or decreased sensation, pain, or discomfort. These may be signs of neuropathic pain or peripheral neuropathy
• Fever, chills, sore throat, painful or difficult urination, or other symptoms of a cold or flu. These may be a signs of an infection or neutropenia, a serious condition caused by a decrease in the number of white blood cells
• Constipation, nausea, vomiting, confusion or difficulty thinking clearly, lack of appetite, pain, frequent urination, increased thirst. These may be signs of hypercalcemia, a serious condition caused by increased bone destruction

If you have any these serious side effects or any other severe side effects, your doctor will stop treating you with Velcade until the symptoms improve. Velcade can then be started again at a lower dose.

Patients who experience neuropathic pain and/or peripheral neuropathy on Velcade therapy should have their dose and/or schedule adjusted as indicated here. In most patients who experience these side effects, they appear to be reversible.

Learn more about Velcade:

• Velcade and Relapsed and Refractory Myeloma
• Velcade and Upfront Therapy