Patients with primary systemic amyloidosis will be treated with CC-5013 (lenalidomide; Revlimid) as a single agent for 3 months. If their disease worsens or does not improve during that time frame dexamethasone will be added to the treatment program.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle
Mayo Clinic
Rochester, Minnesota, United States
To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis
Time frame: 12 months
Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone
Time frame: 12 months
Hematologic response rate of CC-5013 and dexamethasone
Time frame: 12 months
Organ response of CC-5013 and the CC-5013 dexamethasone combination
Time frame: 12 months
Time to progression
Time frame: 5 years
Survival
Time frame: 5 years
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