Liposomal daunorubicin and dexamethasone as a treatment for multiple myeloma--the DD Protocol.
OBJECTIVE
Liposomal daunorubicin has been used to treat hematological malignancies, including multiple myeloma (MM). The goal was to evaluate efficacy, side-effects and toxicity of liposomal daunorubicin and dexamethasone ("DD Protocol").


METHODS
Prospective study at Sírio-Libanês, São Camilo, Brasil and Alemão Oswaldo Cruz hospitals.


METHODS
Twenty consecutive patients with active MM received four cycles of liposomal daunorubicin intravenously for two hours (25-30 mg/m(2)/day) on three consecutive days per month, with oral dexamethasone (10 mg every six hours) on four consecutive days three times a month.


RESULTS
The male/female ratio was 1:1 and median age 60. Nine patients were stage IIA, ten IIIA and one IIIB. The median from diagnosis to starting DD was 13 months. All patients received four cycles, except one. Fifteen had already received chemotherapy before DD. Responses of > 50% reduction in serum monoclonal paraprotein were observed in six patients after first cycle (30%), six after second (30%) and four after third (20%), while four (20%) did not obtain this. Initially, 17 patients (85%) had anemia: 12 (70%) achieved correction. Progressive disease was observed in three patients (15%), while one had minimal response, four (20%) partial and 12 (60%) complete. Hematological toxicity was acceptable: three patients (15%) had neutrophils < 1,000/mm(3); none had thrombocytopenia. Gastrointestinal toxicity was mild: nausea (10%), anorexia (15%) and no vomiting.


CONCLUSIONS
This treatment has mild toxicity and good response rate. It may therefore be feasible before autologous bone marrow transplantation.
Dulley
Frederico Luiz
FL
Hospital Sírio-Libanês, São Paulo, Brazil. fldulley@usp.br
Saboya
Rosaura
R
Hungria
Vânia Tietsche de Moraes
VT
Bueno
Nadjanara Dorna
ND
Mello
Fernando Gomes de
FG
Frota
Maria Tereza
MT
Chiattone
Carlos Sergio
CS
Barros
José Carlos
JC
Mori
Nair Sumie
NS
Sturaro
Daniel
D
Macedo
Maria Cristina Martins de Almeida
MC
Silva
Roberto Luiz da
RL
Melo
Leila Maria Magalhães Pessoa de
LM
Souza
Cármino Antonio
CA
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003630:Daunorubicin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D010266:Paraproteins / Q000032:analysis; D011446:Prospective Studies; D016896:Treatment Outcome
D008081:Liposomes; D010266:Paraproteins; D003907:Dexamethasone; D003630:Daunorubicin