Publication Date:
2004-11-16
Description:
High-dose melphalan (M) with autologous stem cell transplant (ASCT) is an effective therapy for AL, but treatment-related mortality (TRM) remains high, and hematologic complete responses (CR) occur in a minority of patients. In this study, we asked whether a risk-adapted approach to IV M dosing could decrease TRM, and whether adjuvant D +/− T could improve hematologic and amyloid-involved organ response rates. Other objectives of the trial are to study prospectively the prognostic significance of the serum free light chain (FLC), troponin I, and brain natriuretic peptide (BNP) assays. Newly diagnosed untreated AL patients are risk-stratified upon enrollment. Low-risk patients (1 or 2 major organs involved, no advanced cardiac disease) receive M 100, 140, or 200 mg/m2 with ASCT based on age, presence of cardiac involvement, and renal function. High-risk patients (≥3 organs involved or advanced cardiac disease) receive 2 cycles of M 40 mg/m2 without ASCT. Patients with persistent clonal plasma cell disease at 3 months receive 9 months of adjuvant D+T or D alone (if history of deep venous thrombosis or neuropathy). Since 9/02, 38 patients (median age=57.5 (range 34–73), 68% males) have enrolled. Median time from diagnosis to enrollment is 1.5 months (range 0.5 – 7). Organ involvement includes 13 (34%) cardiac, 24 (63%) renal (12 with renal only), 13 (34%) liver/GI tract, and 10 (26%) peripheral nervous system. Thirty-two (84%) had baseline elevated serum FLC with abnormal κ:λ ratio. Thirty-four patients have been treated--3 high-risk and 31 low-risk (5 at M 100, 16 at 140 and 10 at 200 mg/m2). Treatment-related mortality is 7.4% (2/27) with an additional 7 patients alive
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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