Pethema Multiple Myeloma 2000
Phase 3
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- NCT00560053
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Less 70 years
- ECOG 0-2
- Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl).
- No previous chemotherapy
Exclusion Criteria
- >70 years
- ECOG 3-4
- myeloma quiescent
- cardiopathy
- liver disfunction
- HIV+
- Hepatitis B-C +
- Previous chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method