Thalomid (thalidomide) for Treatment in Myeloma

Thalomid® is an oral immunomodulatory drug, an agent that can modify or regulate the immune system. It has both anti-inflammatory and anti-cancer activities. Thalidomide was first used to treat multiple myeloma in 1997. It was officially approved for use in treating myeloma in combination with the steroid dexamethasone in 2006. The first effective new drug to treat MM in decades, Thalomid launched a new era of "novel therapies." It gave rise to a next generation of immune modulators with increased efficacy and reduced side effects, or the drugs Revlimid® (lenalidomide) and Pomalyst® (pomalidomide).

Currently in the U.S., Thalomid is less commonly prescribed than its successor, Revlimid. However, Revlimid can cause low blood counts, and Thalomid has a smaller impact on the bone marrow's ability to make new blood cells. Thalomid may be a good alternative to Revlimid for patients with low blood cell counts.

How Does It Work?

Like the other immunomodulatory drugs (IMiD® compounds), Thalomid induces immune responses, enhances the ability of immune cells called T cells and NK (natural killer) cells to kill myeloma cells, and inhibits inflammation. It also inhibits the growth of blood vessels upon which cancer cells depend for sustenance and growth.

Possible Side Effects

Drowsiness

Thalidomide often causes feelings of drowsiness. These methods may help relieve this side effect:

• Taking thalidomide at bedtime,
• Avoiding use of other drugs that may cause drowsiness while taking thalidomide,
• Taking other drugs to help alleviate drowsiness at the discretion of your doctor,
• Avoiding alcohol.

Avoid situations in which drowsiness may be a problem. Mental and physical abilities needed to perform dangerous tasks, such as driving a car, may be impaired.

Peripheral neuropathy

Impairment of the nerves in the extremities (hands, arms, legs, feet) is known as peripheral neuropathy. This side effect can be mild, causing tingling in the hands and feet; more rarely, it can be severe and painful. It typically occurs after a long period of taking thalidomide, but it can sometimes occur sooner. These strategies may help alleviate symptoms of peripheral neuropathy:

• Walking and other forms of exercising,
• Avoiding tight shoes and socks with elastic,
• At the discretion of a doctor, reducing the dose of thalidomide,
• At the discretion of a doctor, taking additional medications.

A physician should be notified if any symptoms of peripheral neuropathy occur. If side effects are severe, thalidomide therapy may need to be stopped altogether.

Dizziness

Dizziness may occur during treatment with thalidomide. Sitting up and waiting a few minutes before standing or getting out of bed may help reduce dizziness.

Constipation

Constipation may occur during treatment with thalidomide; however, constipation is rarely severe. Prevention is the key to management.

These strategies may help alleviate constipation:

• Drinking at least 8 glasses of fluid daily,
• Adding plenty of dietary fiber every morning, such as prune juice, apple juice, and bran,
• Exercising,
• At the recommendation of a doctor or nurse, taking stool softeners and laxatives.

If constipation becomes severe, the dose of thalidomide may be lowered or temporarily discontinued.

Rash

In some cases, a rash may develop while taking thalidomide. A mild rash (red or discolored skin, with or without raised bumps) usually begins on the trunk and spreads to the arms and legs. Mild rashes may be relieved in the following ways:

• At the recommendation of a doctor or nurse, taking antihistamines and topical corticosteroids,
• To alleviate dry skin, use oatmeal soap, calendula cream, cocoa butter cream, Eucerin® cream, or Acid Mantle® cream.

Leukopenia

Thalidomide can sometimes cause a decrease in white blood cells. This condition is called leukopenia. Because of this possibility, blood tests need to be done regularly. If the white blood cell count becomes too low, the dose of thalidomide may have to be changed or the treatment may need to be interrupted.

Additional Information

Thalomid® website

Celgene's website for Thalomid® with information on clinical information, prescribing guidelines, benefits and risks, and so forth.

Patient Assistance

Celgene's Patient Support Coordinator Program

Celgene's Patient Support Coordinators assist patients and healthcare providers to navigate the challenges of reimbursement, provide information about co-pay assistance, and answer general questions about Thalomid.

Fast Track for First Prescription™

Celgene has developed a new program called Fast Track for First Prescription™ to help eligible patients receive their first prescriptions for a Celgene product quickly and efficiently. Fast Track is an optional service of Celgene Patient Support that facilitates communication between doctors, patients, insurance providers, risk management programs, pharmacies, and co-pay foundations. A Celgene Patient Support coordinator will ensure that “all the ducks are in a row” as quickly as possible, and remove the hurdles to accessing that first cycle of medication. To be eligible, patients must be receiving their first prescription of either Thalomid or Revlimid, must have documented proof of insurance, and must be registered in a Celgene risk management program and have a valid authorization number. For more information on the program, call the IMF InfoLine at 800-452-2873.

Clinical Trials

Open Thalomid® (thalidomide) Trials

Clinical trials list from clinicaltrials.gov.