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Thalidomide for previously untreated indolent or smoldering multiple myeloma
S V Rajkumar1, A Dispenzieri, R Fonseca
1Division of Hematology, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
Leukemia
|August 2, 2001
Summary
Thalidomide shows activity in treating smoldering or indolent multiple myeloma. However, it is not recommended for initial therapy due to potential toxicities and the possibility of long-term stability without treatment.
Area of Science:
- Hematology
- Clinical Oncology
- Pharmacology
Background:
- Smoldering multiple myeloma (SMM) and indolent multiple myeloma (IMM) are early stages of plasma cell disorders.
- Current treatment strategies for SMM/IMM focus on monitoring or intervention based on risk stratification.
Purpose of the Study:
- To evaluate the efficacy and safety of thalidomide as an initial therapy for patients with asymptomatic SMM or IMM.
- To assess the impact of baseline bone marrow microvessel density (MVD) on treatment response.
Main Methods:
- A clinical trial involving 16 patients with newly diagnosed SMM/IMM.
- Oral thalidomide administration, starting at 200 mg/day and escalating as tolerated to a maximum of 800 mg/day.
- Assessment of treatment response based on reduction in serum and urine monoclonal (M) protein levels; bone marrow MVD evaluated using CD34 immunostaining.
Main Results:
- Overall response rate was 69% (11 of 16 patients), with 6 patients achieving a major response (≥50% M protein reduction).
- Major toxicities included somnolence, syncope, and neutropenia.
- Pre-treatment MVD did not significantly predict response to thalidomide therapy (P=0.09).
Conclusions:
- Thalidomide demonstrates significant activity in newly diagnosed SMM/IMM.
- Due to potential toxicities and the natural course of the disease, thalidomide is not recommended as initial therapy.
- Further randomized trials are necessary to determine if thalidomide can delay progression to active multiple myeloma.