The current standard of care in smoldering multiple myeloma is close follow-up every few months without any chemotherapy. This recommendation results from trials that found no significant improvement in overall survival in patients who received immediate treatment with melphalan plus prednisone for stage I or asymptomatic myeloma, compared with those who received treatment at progression. Hjorth and colleagues49 assigned 50 patients with asymptomatic stage I myeloma to observation versus melphalan plus prednisone chemotherapy. No differences were found in overall survival between the two groups. In another series of 44 patients with asymptomatic myeloma, survival times were similar with immediate or deferred therapy.50

Investigational approaches may be considered for selected patients in appropriate trials. Thalidomide is being studied as a single agent, and a partial response rate of approximately 35% has been noted. However, a phase III randomized study comparing no therapy with thalidomide or other agents such as bisphosphonates, IL-ip inhibitors, clarithromycin, or dehydroepiandrosterone is required before making any recommendations concerning therapy of smoldering multiple myeloma.

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