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 Blood, 15 October 2008, Vol. 112, No. 8, pp. 3122-3125.
Prepublished online as a Blood First Edition Paper on July 31, 2008; DOI 10.1182/blood-2008-06-164228.

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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

Seven-year median time to progression with thalidomide for smoldering myeloma: partial response identifies subset requiring earlier salvage therapy for symptomatic disease

Bart Barlogie1, Frits van Rhee1, John D. Shaughnessy, Jr1, Joshua Epstein1, Shmuel Yaccoby1, Mauricio Pineda-Roman1, Klaus Hollmig1, Yazan Alsayed1, Antje Hoering2, Jackie Szymonifka2, Elias Anaissie1, Nathan Petty1, Naveen S. Kumar1, Geetika Srivastava1, Bonnie Jenkins1, John Crowley2, and Jerome B. Zeldis3

1 Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock; 2 Cancer Research and Biostatistics, Seattle, WA; and 3 Celgene, Summit, NJ

Smoldering multiple myeloma (SMM) is usually followed expectantly without therapy. We conducted a phase 2 trial in 76 eligible patients with SMM, combining thalidomide (THAL, 200 mg/d) with monthly pamidronate. In the first 2 years, THAL dose reduction was required in 86% and drug was discontinued in 50%. Within 4 years, 63% improved, including 25% qualifying for partial response (PR); by then, 34 patients had progressed and 17 required salvage therapy. Unexpectedly, attaining PR status was associated with a shorter time to salvage therapy for disease progression (P < .001), perhaps reflecting greater drug sensitivity of more aggressive disease. Low beta-2-microglobulin levels less than 2 mg/L were independently associated with superior overall and event-free survival. Four-year survival and event-free survival estimates of 91% and 60%, respectively, together with a median postsalvage therapy survival of more than 5 years justify the conduct of a prospective randomized clinical trial to determine the clinical value of preemptive therapy in SMM. Trial registered at http://www.clinicaltrials.gov under identifier NCT00083382 [ClinicalTrials.gov] .


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