Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00607581|
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : February 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyloidosis||Drug: cyclophosphamide Drug: lenalidomide Drug: dexamethasone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
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
- hematologic response rate [ Time Frame: at 3 months ]
- organ response rate [ Time Frame: at 3 months ]
- time to response [ Time Frame: every 28 days ]
- time to progression [ Time Frame: every 3 months for 3 years ]
- survival [ Time Frame: up to 3 years after treatment discontinuation ]
- toxicity [ Time Frame: continuous during treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607581
|Amyloidosis Research and Treatment Center - Fondazione IRCCS Policlinico San Matteo|
|Pavia, Italy, 27100|
|Principal Investigator:||Giampaolo Merlini, M.D.||Fondazione IRCCS Policlinico San Matteo|