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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis|
- hematologic response rate [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
- organ response rate [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
- time to response [ Time Frame: every 28 days ] [ Designated as safety issue: No ]
- time to progression [ Time Frame: every 3 months for 3 years ] [ Designated as safety issue: No ]
- survival [ Time Frame: up to 3 years after treatment discontinuation ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: continuous during treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
The participants receive up to 9 28-day cycles of
cyclophosphamide: 500 mg orally on days 1, 8, 15
Other Names:Drug: lenalidomide
lenalidomide: 15 mg orally on days 1-21
Other Names:Drug: dexamethasone
dexamethasone: 40 mg orally on days on days 1, 8, 15, 22
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).
- 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.
|Amyloidosis Research and Treatment Center - Fondazione IRCCS Policlinico San Matteo|
|Pavia, Italy, 27100|
|Principal Investigator:||Giampaolo Merlini, M.D.||Fondazione IRCCS Policlinico San Matteo|