Amyloidosis Clinical Trial
Official title:
An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that
produce the light-chain forming the amyloid deposits. The plasma cells can be killed and
their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide,
steroids, such as dexamethasone, and drugs that stimulate the immune system, such as
lenalidomide.
The present trial studies the efficacy and safety of the combination of cyclophosphamide,
lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated
and need further therapy.
This study will include previously treated patients with AL amyloidosis.
Primary objectives to determine the hematologic and organ response rate to the association
of cyclophosphamide, lenalidomide and dexamethasone (CLD).
Secondary objectives
- to determine the safety of CLD,
- to determine time to response to CLD,
- to determine the duration of response to CLD,
- to assess survival of AL amyloidosis patients treated with CLD.
Patients receive 28-day cycles cyclophosphamide on days 1, 8 and 15, oral lenalidomide on
days 1-21 and oral dexamethasone on days 1, 8, 15, and 22.
Up to 9 courses can be performed until one of the following endpoints is met:
- completion of cycle 9,
- complete hematologic remission observed after cycle 3 or 6,
- partial hematologic response associated with organ response after cycle 6.
- no response at cycle 3 or 6. After completion of study treatment, patients are followed
every 3 months for up to 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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