Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Mel100
|
Procedure: Autologous transplantation
Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
|
| Experimental: Mel200
|
Procedure: Autologous transplantation
Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
|
Outcome Measures
Primary Outcome Measures
- Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression. []
Secondary Outcome Measures
- Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression. []
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Azienda Ospedaliera San Giovanni Battista
Investigators
- Principal Investigator: Mario Boccadoro, MD, Division of Hematology - University of Torino - A.O.U. San Giovanni Battista
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GISMM2001