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U.S. Department of Health and Human Services

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Questions and Answers on Velcade

 

  1. What is Velcade and how does it work?
  2. What is Velcade used for?
  3. Are proteasomes found in only cancer cells?
  4. What is Multiple Myeloma?
  5. What are the symptoms of Multiple Myeloma?
  6. How many clinical studies were performed with Velcade and what did they show?
  7. If Velcade decreased tumor volume, why is it reserved for people who have failed at least two other types of treatment for multiple myeloma?
  8. Is Velcade a cure for multiple myeloma?
  9. What is accelerated approval?
  10. What are the side effects of Velcade?
  11. How is Velcade given?
  12. What if I am taking other drugs?
  13. Where can I find more information on Velcade? 
     

 1.  What is Velcade and how does it work?

Velcade is a new type of cancer drug called a proteasome inhibitor. Proteasomes are enzymes found in cells, and play a role in regulating cell function and growth. Velcade blocks the activity of proteasomes. This blockade can lead to death of cancer cells. The active ingredient in Velcade is bortezomib.

 2.  What is Velcade used for?

Velcade is used to treat a type of cancer called multiple myeloma. It should only be used in people who have already been treated with two other types of chemotherapy (drugs used to kill cancer cells), and whose cancer has still progressed on the most recent therapy.

 3.  Are proteasomes found in only cancer cells?

No, proteasomes are found in all cells, and are necessary for cells to survive and grow. Velcade may kill some good cells along with the cancer cells, which can lead to side effects.

 4.  What is Multiple Myeloma?

Multiple myeloma is a type of cancer. In multiple myeloma, cancerous plasma cells are found in the bone marrow. In multiple myeloma, plasma cells grow out of control in the bone marrow, causing bone and kidney damage and suppression of the normal bone marrow (which makes the red blood cells that carry oxygen, the white blood cells that fight infection, and the platelets that stop bleeding) and the immune system.

 5.  What are the symptoms of Multiple Myeloma?

In the earliest stage of the disease, there may be no symptoms. When symptoms do occur, patients commonly have bone pain, often in the back or ribs. Patients also may have broken bones, weakness, tiredness, weight loss, or repeated infections. In the later stages, symptoms may include nausea, vomiting, constipation, problems with urination, and weakness or numbness in the legs. These are not sure signs of multiple myeloma; they can be symptoms of other types of medical problems.

 6.  How many clinical studies were performed with Velcade and what did they show?

FDA based approval of Velcade on the results of two studies, both of which showed a decrease in the size of the tumors (tumor volume). The main study involved 202 people whose cancer had progressed even though they had received at least two previous types of chemotherapy. Twenty-eight percent of the patients showed an overall partial response rate to Velcade. Median duration of response was 365 days. In a smaller study involving 54 people, Velcade decreased tumor volume in 30-38% of people.

 7.  If Velcade decreased tumor volume, why is it reserved for people who have failed at least two other types of treatment for multiple myeloma?

Velcade is indicated as third-line treatment (i.e. after two previous treatments have failed) because there are other treatments for earlier stages of disease. It is not known whether Velcade is better, as good as, or worse than these other treatments.

 8.  Is Velcade a cure for multiple myeloma?

No, Velcade is not a cure for multiple myeloma.

 9.  What is accelerated approval?

Accelerated approval is a program the FDA developed to make new drug products available for life threatening diseases when they appeared to provide a benefit over available therapy (which could mean there was no existing effective treatment). Under this program, Velcade is approved on the basis of early clinical study evidence (such as tumor shrinkage) suggesting that the drug is reasonably likely to have a valuable effect on survival or symptoms. The approval is granted on the condition that the manufacturer must continue testing to demonstrate that the drug indeed provides therapeutic benefit to the patient. If it does not, the FDA can withdraw the product from the market more easily than usual.

 10.  What are the side effects of Velcade?

The most common side effects with Velcade are nausea, tiredness, diarrhea, constipation, decreased platelet blood count (causing easier bruising and bleeding), fever, vomiting, and decreased appetite. Velcade can cause peripheral neuropathy (loss of sensation in the arms and legs). The most commonly reported serious adverse effects with Velcade include fever, pneumonia, diarrhea, vomiting, dehydration, and nausea.

 11.  How is Velcade given?

Velcade is given by injection into the bloodstream twice a week for two weeks, followed by a 10 day rest period.

 12.  What if I am taking other drugs?

Velcade may interact with other medications, especially with those that share the same side effects. It is always best to tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

 13.  Where can I find more information on Velcade?