A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis
* Assess the hematologic response rate in patients with primary systemic amyloidosis treated
with lenalidomide, cyclophosphamide, and dexamethasone.
- Determine the organ response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide* on days 1,
8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
NOTE: *Patients may receive cyclophosphamide for up to 1 year. After completion of study
treatment, patients are followed every 6 months for up to 3 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
Duration on study (up to 3 years)
Shaji K. Kumar, MD
United States: Food and Drug Administration
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