None listed
Conditions
Interventions
Dexamethasone 40 mg / day days 1-4
17-20 every 4 weeks for 4 cycles.
Thalidomide / Dexamethasone Type of group
Thalidomide 200 mg / day for 4 weeks plus dexamethasone 40 mg / day between days 1-4
9-12
Dexametasone Type of group
Sponsors
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Eligibility
Inclusion criteria
Inclusion criteria: • Age> 18 years. Functional status ECOG O, 1 or 2. • Bone marrow obtained within 4 weeks prior to the randomization with plasmacytosis> 10% plasma cells or layers of Plasma cells or proven biopsy of plasmacytoma. • Patients will not enter the protocol with smoldering myeloma or monoclonal gammapathy of undetermined significance. • Neither who have had previous treatment for multiple myeloma or the previous use of spheroids or Dexamethasone. • No prior history of malignancy unless you are without evidence of disease and time required to be considered cured. • Neither that has active infection or past or present history of Deep venous thrombosis. • No current treatment with anticoagulants. • Women of reproductive age should use two contraceptive methods insurance from 4 weeks before, up to 4 weeks after finishing the treatment with Thalidomide. • Equally sexually active males (even with vasectomy) should use a condom during the use of the drug and up to 4 weeks after suspend the treatment.
Exclusion criteria
Exclusion criteria: not contemplated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:All patients will be followed to evaluate disease-free survival, until death. Measure:Response rate and toxicity to Thalidomide plus Dexamethasone and Dexamethasone alone in newly diagnosed patients with multiple myolema Timepoints:After 4 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Peru, United States
Outcome results
None listed