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

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00950768
First received: July 31, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 31, 2009
July 31, 2009
February 2002
May 2009   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.
Same as current
Not Provided
Not Provided
 
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Diagnosis
Procedure: Autologous transplantation
Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
  • Active Comparator: Mel100
    Intervention: Procedure: Autologous transplantation
  • Experimental: Mel200
    Intervention: Procedure: Autologous transplantation
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. Epub 2009 Dec 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
June 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00950768
GISMM2001
Not Provided
Mario Boccadoro, Division of Hematology - University of Torino - A.O.U. San Giovanni Battista
Azienda Ospedaliera San Giovanni Battista
Not Provided
Principal Investigator: Mario Boccadoro, MD Division of Hematology - University of Torino - A.O.U. San Giovanni Battista
Azienda Ospedaliera San Giovanni Battista
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP