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A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis

NCT02545907 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-15

Study results available
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Summary

This study evaluates the safety and efficacy of carfilzomib used in combination with thalidomide and dexamethasone in patients with relapsed AL amyloidosis. The trial begins with a dose escalation phase, in which the maximum tolerated and recommended dose will be determined. The trial will then open into an expansion phase in which the combination efficacy is assessed.

Conditions

  • Amyloidosis

Interventions

DRUG

Carfilzomib

Lyophilized carfilzomib for injection reconstituted with water to a final concentration of 2 mg/mL.

DRUG

Thalidomide

50mg capsule.

DRUG

Dexamethasone

2mg tablet.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Ashutosh Wechalekar, Dr · University College London, National Amyloidosis Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2019-09-26
Completion
2019-10-21

Countries

  • United Kingdom

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 NCT02545907 on ClinicalTrials.gov