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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. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS Access through
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Read our FAQs * Contact customer support SIMILAR CONTENT BEING VIEWED BY OTHERS SMOLDERING MULTIPLE MYELOMA CURRENT TREATMENT ALGORITHMS Article Open access 05 September 2022 DEEPER RESPONSE
PREDICTS BETTER OUTCOMES IN HIGH-RISK-SMOLDERING-MYELOMA: RESULTS OF THE I-PRISM PHASE II CLINICAL TRIAL Article Open access 03 January 2025 OBSERVATION OR TREATMENT FOR SMOLDERING MULTIPLE
MYELOMA? A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED STUDIES Article Open access 26 May 2025 REFERENCES * Greenlee RT, Murray T, Bolden S, Wingo PA . Cancer statistics,
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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. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Division of Hematology, Mayo
Clinic and Mayo Foundation, Rochester, MN, USA SV Rajkumar, A Dispenzieri, R Fonseca, MQ Lacy, S Geyer, JA Lust, RA Kyle, PR Greipp, MA Gertz & TE Witzig Authors * SV Rajkumar View
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Fonseca View author publications You can also search for this author inPubMed Google Scholar * MQ Lacy View author publications You can also search for this author inPubMed Google Scholar *
S Geyer View author publications You can also search for this author inPubMed Google Scholar * JA Lust View author publications You can also search for this author inPubMed Google Scholar *
RA Kyle View author publications You can also search for this author inPubMed Google Scholar * PR Greipp View author publications You can also search for this author inPubMed Google Scholar
* MA Gertz View author publications You can also search for this author inPubMed Google Scholar * TE Witzig View author publications You can also search for this author inPubMed Google
Scholar RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE 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 Download citation * Received: 27 February 2001 * Accepted: 26 April 2001 * Published:
26 July 2001 * Issue Date: 01 August 2001 * DOI: https://doi.org/10.1038/sj.leu.2402183 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get
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thalidomide * angiogenesis * smoldering multiple myeloma * indolent myeloma