Thalidomide plus dexamethasone (thal/dex) and thalidomide alone (thal) as first line therapy for newly diagnosed myeloma (mm)

S. V. Rajkumar, S. Hayman, R. Fonseca, A. Dispenzieri, M. Q. Lacy, S. Geyer, L. Wellik, J. A. Lust, R. A. Kyle, P. R. Greipp, T. E. Witzig

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29 Scopus citations


Background: A phase II trial of Thal/Dex combination and Thai as first line therapy in new untreated MM with laboratory correlative studies (interim analysis). Methods: Patients (pts) with active MM were treated with the Thal/Dex combination. Pts with smoldering or indolent MM (SMM/IMM) were treated with Thai alone. Thai 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. Dex was given orally at a dose of 40 mg/day orally on days 1-4, 9-12, 17-20 (odd cycles) and 40 mg/day days 1-4 (even cycles) repeated monthly. Response was defined as a decrease in serum and urine monoclonal (M) protein by 50% or greater. Bone marrow (BM) microvessel density (MVD) using immunostaining for CD34 was estimated by determining the average number of vessels in 3 hot spots at 400x magnification. BM angiogenesis was also visually graded as low, intermediate and high. Results: 42 pts (26 with active MM and 16 with smoldering/indolent MM) were studied. In the Thal/Dex arm, 2 pts had grade 3-4 skin toxicity among the first 7 pts treated, at Thai dose of 400mg. The Thal/Dex arm was then amended to stop dose escalation, and keep Thai dose constant at 200mg. An objective response was seen in 20 pts (77%) with active MM treated with Thal/Dex. The response rate was 86% with Thai dose escalation (6 of 7 pts), and 74% with Thai dose constant at 200mg (14 of 19 pts). Major grade 3-4 toxicities were rash in 3 pts, and sedation, constipation and myalgias in 1 pt each. In the SMM/IMM arm, 6 pts (38%) achieved a response with Thai alone. Median pre-treatment MVD was 27 in the active MM arm, and 7 in the SMM/IMM arm (p<0.001). Angiogenesis grade was high in 64% of active MM and 8% of SMM/IMM, (p<0.001). The proportion of pts with a high(l) PCLI was 67%, 9%, 0% for high, intermediate, and low grade angiogenesis respectively (p<0.001 ). No significant changes were observed in MVD following treatment; pre-treatment MVD and angiogenesis grade did not appear to be associated with response to therapy. Conclusions: Thal/Dex is strikingly effective as first line therapy (and an oral alternative to infusional VAD) for new, active MM. SMM/IMM pts also appear to achieve significant responses with Thai alone. However, these results are preliminary and responses/toxicities are still being evaluated and need further confirmation in the final analysis of this trial.

Original languageEnglish (US)
Pages (from-to)167a
Issue number11 PART I
StatePublished - Dec 1 2000

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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