A multicenter randomized trial has determined that a regimen Thalomid (thalidomide) and dexamethasone is superior to dexamethasone alone for the initial treatment of patients with multiple myeloma. The details of this large randomized trial were presented at the 2006 meeting of the American Society of Clinical Oncology in Atlanta.

Thalomid was approved by the U.S. Food and Drug Administration (FDA) in May 2006 for the initial treatment of patients with multiple myeloma. The study presented at ASCO 2006 presumably comprised much of the data leading to FDA approval. However, even prior to FDA approval the majority of newly diagnosed patients with multiple myeloma received regimens containing Thalomid. At the present time the optimal use of Thalomid for the treatment of myeloma is still being investigated. In, addition the recent approval of the thalidomide analog, Revlimid®, will further complicate treatment decisions.

In this study 470 newly diagnose patients with multiple myeloma were randomly allocated to 28 day cycles of dexamethasone plus placebo or dexamethasone plus Thalomid. The median age of the study population was 65 years. The median follow-up of this study was 25 months. Time to tumor progression was 17.5 months in the Thalomid group and 6.4 months in the control group. Deep vein thromboses occurred in 15% of the Thalomid group and 4.3% of the control group. Toxicities of any type occurred in 25% of the Thalomid group and 17% of the control group.

Comments: These data led to the approval of Thalomid for first-line treatment of patients with multiple myeloma. The Thalomid/Dexamethasone regimen is likely to be used only in older patients or those with significant co-morbidities as more aggressive therapy will be used for most patients. FDA approval of Revlimid for treatment of myeloma may also change current treatment patterns.

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Reference: Rajkumar SV, Hussein M, Catalono J, et al. A multicenter, randomized, double-blind, placebo-controlled trial of thalidomide plus dexamethasone versus dexamethasone alone as initial therapy for newly diagnosed multiple myeloma. Journal of Clinical Oncology. 2006;24:Abstract # 7517.