Celgene Corporation's German subsidiary last week issued a “Dear Health Care Professional” letter warning that thalidomide increases the risk of blood clots in arteries, which can lead to heart attacks and strokes. According to Celgene’s letter, the prescribing information for thalidomide in Europe has been updated to include a warning about this risk.

In Europe, thalidomide (Thalomid) is approved for use in combination with melphalan (Alkeran) and prednisone in newly diagnosed multiple myeloma patients over the age of 65 and newly diagnosed patients who are not candidates for stem cell transplantation. 

In the United …

In a recent literature review, Canadian researchers confirmed that the use of aspirin, warfarin, and heparin decreases the risk for blood clots in multiple myeloma patients receiving thalidomide treatment.

However, the authors of the review pointed out that they were unable to recommend a specific strategy for blood clot prevention due to inconsistent reporting of blood clotting events among the trials. 

They pointed out that randomized, controlled trials directly comparing the different medications are needed in order to determine the true efficacy of the preventative medications.

In addition, the authors of the …

The U.S. Food and Drug Administration (FDA) announced last week that it is investigating the safety of the multiple myeloma drugs Revlimid and thalidomide.  The Beacon covered this development in an earlier article.  More details are provided here about why the FDA is conducting the investigation and the possible outcomes of that investigation.  These questions and answers have been developed in consultation with the FDA.

Why is the FDA investigating the safety of Revlimid and thalidomide?

In December, intermediate results from three clinical trials studying long-term use of Revlimid …

The U.S. Food and Drug Administration (FDA) earlier today issued a formal announcement that it is investigating the safety of  the multiple myeloma treatments Revlimid and thalidomide. 

The investigation is being carried out due to clinical trial results that suggest Revlimid may increase the risk of secondary cancer in patients taking the drug for extended periods of time.

The announcement confirms a Beacon news update last week that reported evidence that an investigation of Revlimid was underway (see related Beacon news).

Today's FDA statement says that the agency is "aware of results from clinical trials ... that have found that patients treated with

A group of Italian researchers found that elevated monoclonal protein levels and decreased platelet counts are associated with an increased risk of severe infection in multiple myeloma patients treated with thalidomide-based combination therapies.

The researchers also showed that patients who were at a low or intermediate risk for severe infections did not benefit from preventative treatment with antibiotics.

“I think it is reasonable to stop taking prophylaxis in low-intermediate risk patients,” said Dr. Massimo Offidani, lead author of the study. “If a patient is at a high risk of infection, thalidomide and …

Results of an Italian study show that patients taking Revlimid who progressed on thalidomide had similar overall response and survival rates as patients taking Revlimid who discontinued thalidomide after achieving at least a partial response.

Based on these results, the study authors concluded that Revlimid (lenalidomide) may be equally effective in myeloma patients who previously progressed on thalidomide and myeloma patients who previously responded to thalidomide.

Revlimid and thalidomide (Thalomid) belong to the same class of drugs called immunomodulatory agents; however, they produce different side effects. Compared to thalidomide, Revlimid …

An international group of myeloma researchers has recently identified five genetic variations that may be associated with an increased risk of developing thalidomide-related peripheral neuropathy.  Several of these genes are involved in repairing nerves or controlling inflammation in the peripheral nervous system.

The researchers indicated that these genetic variations may be a tool to help identify patients who are at a greater risk of developing thalidomide-related peripheral neuropathy.

However, the researchers pointed out that their findings were based on data from patients who received intermediate doses of thalidomide and who developed the …