Pethema Multiple Myeloma 2000

PETHEMA Foundation

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Procedure: Autologous Transplantation; Drug: Maintenance; Procedure: ALOGENIC MINI TRASPLANTATION; Procedure: Second transplantation; Drug: Alternating chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00560053

PETHEMA MM-2000

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: Under 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)