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Report for Clinical Trial NCT00607581

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT00607581 Amyloidosis
MeSH:Immunoglobulin Light-chain Amyloidosis Amyloidosis

3 Interventions

Name: cyclophosphamide

Description: cyclophosphamide: 500 mg orally on days 1, 8, 15
Type: Drug
Group Labels: 1


Name: lenalidomide

Description: lenalidomide: 15 mg orally on days 1-21
Type: Drug
Group Labels: 1


Name: dexamethasone

Description: dexamethasone: 40 mg orally on days on days 1, 8, 15, 22
Type: Drug
Group Labels: 1


Primary Outcomes

Measure: hematologic response rate

Time: at 3 months

Secondary Outcomes

Measure: organ response rate

Time: at 3 months

Measure: time to response

Time: every 28 days

Measure: time to progression

Time: every 3 months for 3 years

Measure: survival

Time: up to 3 years after treatment discontinuation

Measure: toxicity

Time: continuous during treatment

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 G21210A

Prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency. --- G21210A ---

HPO Nodes