A combination of melphalan, prednisone, and 50 mg thalidomide treatment in non-transplant-candidate patients with newly diagnosed multiple myeloma.
OBJECTIVE
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 ≥ 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/m(2) melphalan and 40 mg/m(2) 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.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Hye Jung
HJ
Chang
Jae Hoon
JH
Lee
Young Rok
YR
Do
Sung-Hwa
SH
Bae
Jung-Lim
JL
Lee
Seung Hyun
SH
Nam
Sung-Soo
SS
Yoon
Soo-Mee
SM
Bang
D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D016001:Confidence Intervals; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007723:Korea; D008297:Male; D008558:Melphalan / Q000627:therapeutic use*; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000627:therapeutic use*; D012306:Risk; D013792:Thalidomide / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D020533:Angiogenesis Inhibitors; D018906:Antineoplastic Agents, Alkylating; D018931:Antineoplastic Agents, Hormonal; D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone