NCT00443235

GEM05 for Patients With Multiple Myeloma More Than 65 Years Old

A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 66 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments

Detailed description

A total of up to 260 patients \> 65 years old diagnosed of Multiple Myeloma with symptomatic disease and that have not received previous chemotherapy for MM will be included. Patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up. The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility and then Patients will be randomized one to one to receive Melphalan+Prednisone+Velcade (Group A) or Thalidomide+Prednisone+Velcade (Group B). All of them will received the induction treatment up to 30 weeks. After 4 weeks, without progression and unacceptable toxicity, Patients will be again randomized one to one to receive maintenance treatment: Thalidomide+Velcade (Group M1) or Prednisone+Velcade (Group M2) during three years. Once the treatment period has finished a follow up will be carry out. During this period we will evaluated response, progression-free survival and global survival every three months.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Melphalan/Prednisone/Velcade	One cycle: Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)
DRUG	Thalidomide/Prednisone/Velcade	One cycle: Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity \< grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-03-01
• Completion: 2009-12-01
• First posted: 2007-03-05
• Last updated: 2011-09-19

Locations

77 sites across 1 country: Spain