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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950768
• Other study ID #: GISMM2001
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2009
• Last updated: July 31, 2009
• Start date: February 2002
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diagnosis
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• Autologous transplantation
Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.