Authors: | Hassoun, H.; Reich, L.; Klimek, V. M.; Dhodapkar, M.; Cohen, A.; Kewalramani, T.; Zimman, R.; Drake, L.; Riedel, E. R.; Hedvat, C. V.; Teruya-Feldstein, J.; Filippa, D. A.; Fleisher, M.; Nimer, S. D.; Comenzo, R. L. |
Article Title: | Doxorubicin and dexamethasone followed by thalidomide and dexamethasone is an effective well tolerated initial therapy for multiple myeloma |
Abstract: | Among the drug combinations designed for the initial treatment of multiple myeloma, none has been unequivocally shown to be superior. However, a regimen leading to a high response rate and a low incidence of adverse events is highly desirable. We report the results of a phase II clinical trial involving 45 patients with Durie-Salmon stage II and III multiple myeloma. Doxorubicin and dexamethasone were given for 2 or 3 months followed by thalidomide and dexamethasone for 2 months (AD-TD regimen) with prophylactic antibiotics and daily aspirin (81 mg/d). Among the 42 patients whose response could be assessed, 38 responded to therapy (90.5%). The intent-to-treat response rate was 84.4% with seven complete responses (CR 15.5%), nine near complete responses (nCR 20.0%), and 22 partial responses (PR 48.9%). Two patients had stable disease (4.4%), and two progression of disease (4.4%). Normalization of the free light chain ratio after one or two cycles of treatment was highly predictive of achievement of CR or nCR. Patients tolerated the treatment well although five patients developed thromboembolic complications (11%). AD-TD administered with low dose aspirin for deep vein thrombosis prophylaxis was well tolerated and yielded a high response rate with minimal treatment-related morbidity. © 2005 Blackwell Publishing Ltd. |
Keywords: | adult; clinical article; controlled study; treatment response; aged; antibiotic agent; thalidomide; clinical trial; constipation; disease course; drug tolerability; neutropenia; doxorubicin; cancer combination chemotherapy; hypophosphatemia; side effect; neurotoxicity; outcome assessment; edema; low drug dose; controlled clinical trial; drug eruption; infection; multiple myeloma; phase 2 clinical trial; anemia; nausea; thrombocytopenia; dehydration; peripheral neuropathy; morbidity; dexamethasone; deep vein thrombosis; drug effect; prediction; hyperglycemia; lymphocytopenia; lung embolism; chemotherapy induced emesis; confusion; gastrointestinal toxicity; hyponatremia; cancer regression; acetylsalicylic acid; thromboembolism; prophylaxis; cotrimoxazole; antibiotic prophylaxis; ataxia; fluconazole; vitamin b complex; omeprazole; phlebitis; weight gain; bloating; mood change; free light chain |
Journal Title: | British Journal of Haematology |
Volume: | 132 |
Issue: | 2 |
ISSN: | 0007-1048 |
Publisher: | John Wiley & Sons |
Date Published: | 2006-01-01 |
Start Page: | 155 |
End Page: | 161 |
Language: | English |
DOI: | 10.1111/j.1365-2141.2005.05848.x |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | --- - "Cited By (since 1996): 29" - "Export Date: 4 June 2012" - "CODEN: BJHEA" - "Source: Scopus" |