A Combination of Melphalan, Prednisone, and 50 mg Thalidomide Treatment in Non-Transplant-Candidate Patients with Newly Diagnosed Multiple Myeloma.
10.3904/kjim.2011.26.4.403
- Author:
Hye Jung CHANG
1
;
Jae Hoon LEE
;
Young Rok DO
;
Sung Hwa BAE
;
Jung Lim LEE
;
Seung Hyun NAM
;
Sung Soo YOON
;
Soo Mee BANG
Author Information
1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. smbang7@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Multiple myeloma;
Thalidomide;
Melphalan;
Prednisone
- MeSH:
Aged;
Angiogenesis Inhibitors/*therapeutic use;
Antineoplastic Agents, Alkylating/*therapeutic use;
Antineoplastic Agents, Hormonal/*therapeutic use;
Confidence Intervals;
Disease Progression;
Drug Therapy, Combination;
Female;
Humans;
Kaplan-Meier Estimate;
Korea;
Male;
Melphalan/*therapeutic use;
Middle Aged;
Multiple Myeloma/*drug therapy/mortality;
Prednisone/*therapeutic use;
Risk;
Thalidomide/*therapeutic use;
Time Factors;
Treatment Outcome
- From:The Korean Journal of Internal Medicine
2011;26(4):403-409
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: The clinical efficacy and safety of a three-drug combination of melphalan, prednisone, and thalidomide were assessed in patients with multiple myeloma who were not candidates for high-dose therapy as a first-line treatment. Because the side effects of thalidomide at a dose of > or = 100 mg daily can be a barrier to effective treatment for these patients, we evaluated the efficacy and safety of a reduced dose of thalidomide, 50 mg, for non-transplant candidates. METHODS: Twenty-one patients were treated in 4-week cycles, receiving 4 mg/m2 melphalan and 40 mg/m2 prednisone on days 1-7 and 50 mg thalidomide daily. The primary efficacy outcome was the overall response rate. Aspirin (100 mg daily) was also provided as prophylactic treatment for thromboembolism. RESULTS: The overall response rate was 57.1%; a complete response was seen in 23.8% of patients, a partial response in 33.3%, and stable disease in 9.5%. After a median follow-up time of 16.1 months, the median time to progression was 11.4 months (95% confidence interval, 2.1 to 20.6); the median overall survival was not reached. Grades 3 and 4 adverse events included infection (10%), peripheral neuropathy (5%), diarrhea (5%), thrombosis (10%), and loss of consciousness (10%). Two patients discontinued treatment due to loss of consciousness and neuropathy. CONCLUSIONS: Low-dose thalidomide (50 mg) plus melphalan and prednisone is an effective combination drug therapy option for newly diagnosed myeloma patients who are ineligible for high-dose chemotherapy.
