Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
In this study will be randomised before induction treatment either to receive two courses of
 melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent
 will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e
 Salmon stage IIA-IIIB measurable multiple myeloma; age < 65 years. Exclusion criteria
 included: prior treatment for myeloma; abnormal cardiac function, defined as systolic
 ejection fraction <50%; abnormal pulmonary spirometry test; serum bilirubins > 2.5 times
 normal and ALAT and/or ASAT > 2 times normal; seropositivity for HIV, HCV or HBV, active
 non-hematologic malignancies.

 Induction therapy, PBSC mobilization, and autografting Initial treatment plan included
 induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2
 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by
 peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of
 cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least
 one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan,
 100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5
 ug/kg, from days +3 until neutrophil count > 1000/ul were achieved.

 Supportive care and toxicity grading Following autografting, all patients received standard
 prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster
 virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored
 through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or
 foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0)
 were used for grading hematological and non-hematological toxicity.
Inclusion criteria included:

 -  diagnosis of untreated Durie & Salmon stage IIA-IIIB measurable multiple myeloma;

 -  age < 65 years.

 Exclusion criteria included:

 -  prior treatment for myeloma;

 -  abnormal cardiac function, defined as systolic ejection fraction <50%;

 -  abnormal pulmonary spirometry test;

 -  serum bilirubins > 2.5 times normal and ALAT and/or ASAT > 2 times normal;

 -  seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.