Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Elderly patients
Brief summary
The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.
Interventions
Sponsors
Gruppo Italiano Studio Linfomi
Study design
Allocation
RANDOMIZED
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed of multiple myeloma. * Age \> 65 years * ECOG \<= 3 * Written informed consent given at the time of randomization * Patients with age \<= 65 but not eligible for high dose treatment with stem cells support
Exclusion criteria
* ECOG \> 3 * current neoplasm.. * contraindications to use thalidomide * peripheral neurophaty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy | from 8 to 12 months | To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment |
| To assess the toxicity | From 1 to 12 months | To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the Overall Survival (OS) in the 2 arms of treatment | From 1 to 60 months | OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause |
| To evaluate the Duration of Remission (DR) in the 2 arms of treatment | From 8 to 60 months | DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination |
Countries
Italy
Outcome results
None listed