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Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis

NCT00607581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Amyloidosis

Interventions

DRUG

cyclophosphamide

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

DRUG

lenalidomide

lenalidomide: 15 mg orally on days 1-21

DRUG

dexamethasone

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

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Giampaolo Merlini, M.D. · Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00607581 on ClinicalTrials.gov