Status:
COMPLETED
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Conditions:
Multiple Myeloma
Diagnosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 obtai...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00950768
Start Date
February 1 2002
End Date
June 1 2009
Last Update
August 3 2009
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