Abstract
We conducted a clinical trial of thalidomide as initial therapy for asymptomatic smoldering (SMM) or indolent multiple myeloma (IMM). Sixteen patients were studied. Thalidomide was given orally at a dose of 200 mg/day for 2 weeks, and then increased as tolerated by 200 mg/day every 2 weeks to a maximum dose of 800 mg/day. Bone marrow microvessel density (MVD) and angiogenesis grading were estimated using CD34 immunostaining. Six patients had a confirmed response to therapy with at least 50% or greater reduction in serum and urine monoclonal (M) protein. When minor responses (25–49%) decrease in M protein concentration) were included, 11 of 16 patients (69%) responded to therapy. Major grade 3–4 toxicities included two patients with somnolence, and one patient each with syncope and neutropenia. Pre-treatment MVD was not a significant predictor of response to therapy, median MVD 4 and 12 in responders and non-responders respectively, P = 0.09. We conclude that thalidomide has significant activity in the treatment of newly diagnosed SMM/IMM. However, we do not recommend treatment with thalidomide at this stage since some patients with SMM/IMM can be stable for several months or years without any therapy. Additional randomized trials are needed to determine if thalidomide will delay progression to active multiple myeloma.
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Acknowledgements
This work was supported by Grants CA85818 and CA62242 from the National Cancer Institute, Bethesda, MD. SVR and RF are supported in part by Leukemia and Lymphoma Society Translational Research Awards. SVR is also supported by the Judith and George Goldman Foundation Fighting Catastrophic Diseases, Lake Forest, Illinois, USA.
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Rajkumar, S., Dispenzieri, A., Fonseca, R. et al. Thalidomide for previously untreated indolent or smoldering multiple myeloma. Leukemia 15, 1274–1276 (2001). https://doi.org/10.1038/sj.leu.2402183
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DOI: https://doi.org/10.1038/sj.leu.2402183
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