This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
200 mg/m2/IV
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
University of Virginia
Charlottesville, Virginia, United States
Event Free Survival
Duration of time until patient experiences an event (recurrence, relapse or death)
Time frame: 3 years
Disease Response
Number of patients that have complete and very good partial responses.
Time frame: 2 years
Overall survival
Duration of time from Day 0 until death.
Time frame: 4 years
Grade > 2 toxicities
Percent of patients experiencing one or more toxicity greater than 2.
Time frame: 4 years
Incidence of infections
Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
Time frame: 4 years
Treatment related Mortality
Number of patients that experience a death from causes other relapse or progression.
Time frame: 4 years
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