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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
HPO: Amyloidosis

3 Interventions

Name: cyclophosphamide

Description: cyclophosphamide: 500 mg orally on days 1, 8, 15

Type: Drug

1

Name: lenalidomide

Description: lenalidomide: 15 mg orally on days 1-21

Type: Drug

1

Name: dexamethasone

Description: dexamethasone: 40 mg orally on days on days 1, 8, 15, 22

Type: Drug

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

Single Group Assignment


There is one SNP

SNPs


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


HPO:
Amyloidosis
Genes 30
LIG4 TNFRSF1A APOA1 NLRP1 SLC7A7 CST3 MEFV GSN SAA1 OSMR PSEN2 TTR B2M RET ITM2B MEFV NLRP3 NLRP3 IL31RA LYZ ITM2B CCND1 APP PRNP POLA1 CST3 APP APOE FGA NLRP3