Treatment Options - Revlimid
What is Revlimid?
Revlimid (also called lenalidomide) is an oral cancer drug that is used for the treatment of multiple myeloma. It is part of a class of drugs called Immunomodulatory drugs or IMiDs®. IMIDs work against cancer cells partly by impacting the functioning of the immune system.
Revlimid is chemically related to Thalomid® (thalidomide), another IMID, but has been found to be more potent in the laboratory and has different side effects. For example, significant sleepiness, constipation and painful nerve problems (neuropathy), common side effects of Thalidomid, are seen much less frequently with Revlimid.
Revlimid is made by the Celgene Corporation.
How is Revlimid used in multiple myeloma?
Revlimid is a commonly used drug in all stages of multiple myeloma.
Although it can be used alone, it is usually used in combination with another anti-myeloma drug, dexamethasone (dex). This combination is called Revlimid-dex. The combination of Revlimid plus dexamethasone has been shown to be more effective than either drug taken alone.
Revlimid-dex is approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy. It is also commonly used for newly diagnosed or untreated patients.
In addition, the combination of melphalan and prednisone plus Revlimid followed by Revlimid maintenance has been shown to be effective in newly diagnosed/untreated patients over 65 years old who are ineligible for high-dose chemotherapy and stem cell transplantation.
Further, Revlimid is also being studied in combination with other myeloma drugs (eg, Velcade) as well as other new drugs in development.
How does Revlimid work?
Revlimid works in multiple ways to slow or kill myeloma cells, although the exact way in which it works is not completely understood. It directly affects the tumor cells. It is also known to affect the blood vessels and other substances surrounding a tumor (known as the tumor microenvironment) which help to feed the cancer cell's growth.
How is Revlimid-dex taken?
Revlimid is a capsule that is taken every day for 3 weeks with a 1 week rest period. It is available in several strengths (5mg, 10mg, 15mg and 25mg capsules). The typical starting dose is 25 mg once a day. The minimum dose is 5 mg daily.
Dexamethasone is a pill that is taken along with Revlimid. The dose of dexamethasone is usually 40mg and may be given in two different ways—on a high-dose schedule or on a low-dose schedule.
High-dose dexamethasone is typically taken only on certain days of the month, at a starting dose of 40mg (usually given as ten 40mg strength pills). For the first four months, it is taken on days 1-4, 9-12 and 17-20 of each month. Starting at month 5, dexamethasone is only taken on days 1-4 of each month. Each month or 28-days of therapy is known a treatment cycle (usually called a 28-day treatment cycle). LEARN MORE »
Low-dose dexamethasone is given once a week. The starting dose of dexamethasone is 40 mg. LEARN MORE »
It is important to take Revlimid-dex exactly as your doctor has prescribed. If you miss or forget to take a dose, do not double the dose the next day. Re-start your therapy at your regular dose.
In addition, a blood thinner such as aspirin is typically taken along with Revlimid-dex to reduce the chance of developing a blood clot.
Your dose may be changed depending upon your response to therapy and side effects.
How long is the treatment with Revlimid-dex?The length of treatment with Revlimid-dex is determined on an individual basis and may depend on a number of factors including:
Patients who expect to proceed to high-dose chemotherapy and stem cell transplant may only receive a few cycles of Revlimid-dex, until they achieve a response. Other patients may choose to continue Revlimid-dex indefinitely, as long as the treatment is working and side effects are manageable. You and your doctor will discuss the length of treatment that is right for you.
What are the possible side effects with Revlimid-dex?
It is important to remember that side effects of all treatments are based on the individual and vary from patient to patient. Most side effects of Revlimid-dex can be easily managed.
The most common side effects of Revlimid-dex seen in large clinical studies are:
Increased diarrhea in patients taking Revlimid-dex for an extended period of time (>8 months) has been seen.
The most serious side effects that may occur while taking Revlimid-dex are low blood counts, blood clots, rare rash or skin reactions and possible birth defects.
Your doctor will monitor your blood counts. Typically, blood counts will be checked every 2 weeks for the first 12 weeks of therapy and at least monthly thereafter.
If your blood counts drop significantly, your doctor may temporarily stop or reduce your dose of Revlimid. If your counts are very low, your doctor may add another drug to help increase your blood counts (eg, colony-stimulating factor known as G-CSF).
Although, it is not clear whether or not Revlimid actually causes these problems, it is important to be aware of them because they can be life-threatening. Call your doctor immediately if you notice any type of unusual rash or skin reaction.
Possible birth defects: Although, Revlimid does not appear to cause the type of severe birth defects seen in the past with Thalidomide. Women who are pregnant or who plan to become pregnant must not take Revlimid. This precaution is due to its similarity to Thalidomide, and some signs of birth defects in animals. A program called RevAssistSM has been created to prevent exposure to Revlimid during pregnancy.
In addition, dexamethasone by itself can cause side effects. Possible side effects of dexamethasone alone include: stomach problems, vomiting, headache, dizziness, insomnia, restlessness, depression, anxiety, acne, increased hair growth, and easy bruising.
Please tell your doctor or nurse if you experience any side effects.
How are side effects of Revlimid-dex managed?
Management of side effects depends on the type and severity of the problem. Some side effects such as mild or moderate diarrhea can be managed with additional medications.
More serious side effects may require you to stop Revlimid-dex either temporarily or permanently. In many cases, Revlimid-dex is stopped temporarily, until the side effect improves, and then re-started at a lower dose. Studies have shown that Revlimid-dex is still effective at lower doses. LEARN MORE »
Does Revlimid cause second cancers?
There have been reports of new second cancers (also called second primary malignancies or SPMs) developing in a small number of myeloma patients who received maintenance therapy, in 3 large clinical studies. In all of these studies Revlimid was used in combination with melphalan. The types of second cancers seen include MDS (myelodysplastic syndrome, a form of preleukemia) and AML (acute myelogenous leukemia). Two of the 3 trials evaluated the use of Revlimid following high-dose chemotherapy with melphalan and stem cell transplant, and one assessed the role of Revlimid following MPR (standard dose melphalan plus prednisone and Revlimid). Additionally, an analysis of 9 studies including nearly 2500 patients showed that patients who received melphalan in combination with Revlimid or Thalomid had approximately double the risk of a second malignancy compared to those who did not receive these drugs (2% versus 1%). While the risk of second cancer is higher among those receiving Revlimid, the total number of patients developing the cancer was still very small.
There have been no additional second cancers in other studies with Revlimid where melphalan was not part of the treatment. Overall, the information available to date indicates that therapy with Revlimid significantly decreases the risk of myeloma disease progression. Hence, some doctors believe that the benefits of Revlimid therapy may outweigh any potential risk of second cancers.
The MMRF urges patients not to make any changes to their treatment regimens without speaking to their doctor, and if you are a candidate for maintenance therapy, to discuss the options, including these emerging data on safety and effectiveness with your doctor before making any decisions.
What types of patients can benefit from Revlimid-dex?Although Revlimid in combination with dexamethasone has been FDA approved in myeloma only for patients who have received at least one prior therapy, this drug has also been shown to be effective in a wide range of patients including:
Is Revlimid-dex effective in treating relapsed or refractory myeloma?
Two large clinical trials showed that Revlimid-dex is significantly more effective than high-dose dexamethasone is typically taken, a standard myeloma treatment in treating relapsed or refractory myeloma. Over 700 patients throughout the world participated in these studies.
Revlimid-dex significantly delayed disease progression and extended survival. Response rates were superior with Revlimid-dex as well:
Besides dexamethasone, what other drugs are being studied in combination with Revlimid?
Revlimid and Velcade® (bortezomib) with or without dexamethasone (also known as VRD) appears to be one of the most promising new combinations. It is being studied in both relapsed/refractory myeloma and in newly diagnosed patients. VRD appeared to be very effective in a small study with patients who had received several prior therapies.
Other promising new cancer drugs that are being studied in combination with Revlimid are listed below.
Promising New Combinations with Revlimid
* Currently approved by the FDA for other cancers
For more information on Revlimid, visit www.revlimid.com.