Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients

NCT ID: NCT00950768

Last Updated: 2009-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2009-06-30

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.

Conditions

Multiple Myeloma; Diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mel100

Group Type: ACTIVE_COMPARATOR

Autologous transplantation

Intervention Type: PROCEDURE

Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2

Mel200

Group Type: EXPERIMENTAL

Autologous transplantation

Intervention Type: PROCEDURE

Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2

Interventions

Autologous transplantation

Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• diagnosis of untreated Durie & Salmon stage IIA-IIIB measurable multiple myeloma;
• age < 65 years.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role: lead

Responsible Party

Division of Hematology - University of Torino - A.O.U. San Giovanni Battista

Principal Investigators

Mario Boccadoro, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Hematology - University of Torino - A.O.U. San Giovanni Battista

References

Palumbo A, Bringhen S, Bruno B, Falcone AP, Liberati AM, Grasso M, Ria R, Pisani F, Cangialosi C, Caravita T, Levi A, Meloni G, Nozza A, Pregno P, Gabbas A, Callea V, Rizzo M, Annino L, De Stefano V, Musto P, Baldi I, Cavallo F, Petrucci MT, Massaia M, Boccadoro M. Melphalan 200 mg/m(2) versus melphalan 100 mg/m(2) in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study. Blood. 2010 Mar 11;115(10):1873-9. doi: 10.1182/blood-2009-09-241737. Epub 2009 Dec 1.

Reference Type: DERIVED

PMID: 19965659 (View on PubMed)

Other Identifiers

GISMM2001

Identifier Type: -

Identifier Source: org_study_id