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Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed

NCT01194791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-25

No results posted yet for this study

Summary

Primary outcome measure:

\- Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and Dexamethasone.

Secondary outcome measures:

* Organ response rate.
* Predictors of response (cardiac biomarkers, serum free light chains).
* Toxicity
* Safety (type, frequency, severity and relationship of adverse events to the study drug).
* Duration of response.
* Time to progression.
* Overall survival

Conditions

  • Primary Systemic Amyloidosis

Interventions

DRUG

Lenalidomide

Lenalidomide 15 mg by mouth for 21 days followed by 7 days rest during 6 cycles

DRUG

Cyclophosphamide

Cyclophosphamide 300 mg/m2, on days 1 and 8 every 4 weeks during 6 cycles

DRUG

Dexamethasone

Oral dexamethasone 20 mg/day on days 1-4 and 9-12 given at 4-week intervals during 6 cycles

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Bladé Joan, Dr · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-09-30
Completion
2016-12-31

Countries

  • Spain

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 NCT01194791 on ClinicalTrials.gov