Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Primary Purpose
Multiple Myeloma, Diagnosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Autologous transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Melphalan, Autologous transplantation
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mel100
Mel200
Arm Description
Outcomes
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.
Full Information
NCT ID
NCT00950768
First Posted
July 31, 2009
Last Updated
July 31, 2009
Sponsor
Azienda Ospedaliera San Giovanni Battista
1. Study Identification
Unique Protocol Identification Number
NCT00950768
Brief Title
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Official Title
GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Diagnosis
Keywords
Myeloma, Melphalan, Autologous transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mel100
Arm Type
Active Comparator
Arm Title
Mel200
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous transplantation
Intervention Description
Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Boccadoro, MD
Organizational Affiliation
Division of Hematology - University of Torino - A.O.U. San Giovanni Battista
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19965659
Citation
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. Erratum In: Blood. 2010 Sep 23;116(12):2195.
Results Reference
derived
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Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
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