Thalidomide: risk of second primary malignancies

Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide monitor for the occurrence of these conditions.

Article date: May 2013

Thalidomide (Thalidomide Celgene) is licensed for use in combination with melphalan and prednisone as first-line treatment for patients with untreated multiple myeloma who are age 65 years or older, or those who are ineligible for high-dose chemotherapy. Thalidomide is an immunomodulatory agent, which has antineoplastic, antiangiogenic, and proerythropoietic properties.

In November 2011, we published information about the risk of development of second primary malignancies with lenalidomide (a structural analogue of thalidomide) in patients treated for myeloma. The risk of second primary malignancies associated with thalidomide was investigated because of the similarities between thalidomide and lenalidomide.

The data show an increased risk of haematological second primary malignancies (acute myeloid leukaemia and myelodysplastic syndromes) in an ongoing study of patients with newly diagnosed multiple myeloma who were receiving melphalan, prednisone, and thalidomide, compared with patients treated with lenalidomide plus dexamethasone. The risk of acute myeloid leukaemia or myelodysplastic syndromes with thalidomide increased from approximately 2% after 2 years to 4% after 3 years.

Advice for healthcare professionals:

  • before starting thalidomide treatment in combination with melphalan and prednisone, take into account both the likely benefit expected from thalidomide and the risk of acute myeloid leukaemia and myelodysplastic syndromes
  • carefully evaluate patients before and during treatment using standard cancer screening and provide appropriate treatment

Further information

Letter sent to healthcare professionals, April 2013

BNF section 8.2.4 Other immunomodulating drugs


Article citation: Drug Safety Update May 2013 vol 6, issue 10: A2.

Published 11 December 2014