Velcade, also known as bortezomib, is the first approved cancer therapy in a class of drugs known as proteasome inhibitors. In the U.S., Velcade is approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma and also for the treatment of mantle cell lymphoma, another type of blood cancer. Velcade is manufactured by Takeda Oncology.
Please visit the sponsor’s official patient site for up-to-date information on Velcade.
In 2022, a generic version of Velcade—available in both intravenous and subcutaneous forms—was approved by the FDA. This generic drug is manufactured by several companies, including Baxter, Zydus Lifesciences, and Fresenius Kabi. In terms of safety, quality, performance characteristics, and intended use, generic Velcade is the same as the marketed brand-name drug manufactured by Takeda Oncology. Generic Velcade can be used as a substitute for Velcade.
Be sure to talk to your myeloma doctor about how you might receive the generic version of Velcade. For more information on generic drugs, please visit the FDA website.
Velcade is used in all stages of multiple myeloma.
Velcade is used as initial therapy in patients, regardless of whether they are candidates for high dose chemotherapy and stem-cell transplant.
Velcade is used alone or in combination with a variety of anti-myeloma drugs for the treatment of relapsed and/or refractory myeloma. It may be used in patients who had previously responded to treatment with Velcade and who have relapsed at least 6 months after completing prior Velcade treatment.
Velcade continues to be studied in combination with other approved myeloma drugs and in combination with new drugs in development.
Velcade has been shown to be effective in a wide range of patients, including:
Velcade is given as an injection, either into the bloodstream (intravenously, IV) or under the skin (subcutaneously, SC or SQ), usually in the thigh or abdomen. SC administration is more frequently used because it is better tolerated than IV administration, and there is reduced risk of peripheral neuropathy, a nerve disorder affecting the hands and feet.
Velcade is given for nine 6-week treatment cycles. In cycles 1–4, Velcade is administered twice a week (days 1, 4, 8, 11, 22, 25, 29, and 32) and in cycles 5–9, Velcade is administered once weekly (days 1, 8, 22, and 29). Different schedules may be used for patients who are receiving treatment for the first time, those receiving treatment for relapsed disease, and those receiving Velcade in combination with other drugs. A typical starting dose is 1.3 mg/m2, but lower IV doses or higher SC doses may also be used. When used as maintenance therapy, Velcade may be administered weekly or less frequently, such as once every 2 weeks, with similar or longer treatment periods.
Dosing adjustments are not necessary for patients with reduced kidney function (renal impairment). However, patients with moderately or severely reduced liver function (hepatic impairment) typically start with a reduced dose of Velcade (0.7 mg/m2). Depending on how this dose is tolerated, subsequent doses may be increased or decreased.
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 any side effects that develop are manageable. You and your doctor can discuss the length of treatment that may be right for you.
If you are being treated with Velcade, your doctor may also give you medication to prevent shingles, a viral infection that causes a painful rash and is due to a reactivation of the herpes zoster virus (the virus that causes chickenpox).
Velcade side effects vary from patient to patient and may be influenced by the current stage of a patient’s myeloma.
The most common possible side effects of Velcade include:
Serious side effects that have been reported with Velcade include:
Note that if you are taking Velcade in combination with other anti-myeloma agents you may experience different side effects.
Also, let your doctor know if you are taking medication for diabetes, as Velcade can affect your blood glucose levels. Your doctor may ask you to closely monitor your blood glucose levels and may adjust the dose of your diabetes medicine while you are being treated with Velcade.
Side effects of Velcade can often be managed with other medications, increasing the amount of fluids, reducing the dose of Velcade, or stopping Velcade treatment temporarily until symptoms resolve.
Patients that develop peripheral neuropathy may be given certain medications that decrease neuropathic pain (such as Neurontin [gabapentin, Pfizer], amitriptyline, Cymbalta [duloxetine, Lilly], or Lyrica [pregabalin, Pfizer]). In addition, certain soothing creams, such as cocoa butter, may be helpful. A number of centers have developed approaches for managing neuropathy.
Always consult with your doctor before taking any supplements or medications. Also, the use of supplements on the day of Velcade administration is not recommended as studies have suggested that there may be a blunting of Velcade effects, though clinically this has not been shown.
Prompt dose reduction and a change in the schedule of Velcade administration are essential in managing peripheral neuropathy.
Preventing the development of side effects, when possible, is an important goal of therapy. For example, once-weekly Velcade dosing is used more frequently because it has been associated with fewer side effects.
SC administration of Velcade may also lessen the development of peripheral neuropathy.
Clinical studies have shown that Velcade is effective as initial therapy in myeloma, as maintenance therapy, and as therapy for previously treated myeloma.
Velcade clinical studies suggest that Velcade-dexamethasone is an effective initial therapy for patients with myeloma, including patients who are eligible for high-dose chemotherapy and stem cell transplant and those who are not.
Revlimid is thought to make myeloma cells more sensitive to Velcade and dexamethasone. The combination of Velcade, Revlimid, and dexamethasone (VRD or RVD) has been shown to be very effective as frontline therapy, with unprecedented activity seen, even in patients with high-risk features. In some cases, a lower dose of dexamethasone is used and the combination is referred to as VRd or RVd
VRD is included in myeloma treatment guidelines as one of several preferred options for initial therapy for transplant candidates, and is one of the most commonly used regimens in transplant candidates in the U. S. VRD is also one of several preferred options for treating myeloma in patients who are not transplant candidates.
The addition of cyclophosphamide to Velcade-dexamethasone has been shown to improve response rates. Velcade-cyclophosphamide-dexamethasone (CyBorD or VCD) is one of several preferred options for frontline therapy in transplant candidates listed in current treatment guidelines. This recommendation is based on the high response rates and rapid responses seen in three phase 2 trials:
CyBorD is also used as initial treatment in patients who are not eligible for transplant.
Velcade is sometimes used as maintenance therapy following stem cell transplantation or other therapy as a way to reduce the risk of relapse and extend survival. Results of several phase 3 trials show that maintenance therapy with weekly Velcade can improve outcome. For example:
Velcade maintenance given every other week for up to 2 years following stem cell transplantation has also been shown to be well tolerated and associated with improvement in response rates and survival, including in patients with poor-risk genetic features, according to results of a phase 3 trial conducted in Europe.
The potential benefits of Velcade maintenance therapy must be balanced with the potential toxicity associated with long-term use of Velcade.
Velcade is used in the treatment of relapsed and/or refractory myeloma.
Data from a large phase 3 clinical trial showed that Velcade was more effective than high-dose dexamethasone (a standard of care at that time). Compared with patients treated with high-dose dexamethasone, patients treated with Velcade had:
Velcade retreatment remains a highly effective therapeutic option for previously treated myeloma. According to an analysis of 23 studies that included a total of 1,051 patients, retreatment with Velcade-based therapy was effective and well tolerated in patients with relapsed/refractory myeloma. The overall response rate to Velcade retreatment across all studies was 39%.
There are many other Velcade combination therapies being evaluated in ongoing clinical trials in myeloma. Some combinations include conventional chemotherapy agents, whereas others include new novel therapies. The following combinations are being tested in phase 3 trials in untreated myeloma:
The following combinations are being tested in phase 3 trials in relapsed and/or refractory myeloma: