Multiple Myeloma Clinical Trial
Official title:
GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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