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GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study


Phase 3
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma, Diagnosis

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Trial Information

GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

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.

Principal Investigator

Mario Boccadoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Italy: Ministry of Health

Study ID:

GISMM2001

NCT ID:

NCT00950768

Start Date:

February 2002

Completion Date:

June 2009

Related Keywords:

  • Multiple Myeloma
  • Diagnosis
  • Myeloma
  • Melphalan
  • Autologous transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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