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Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis

NCT04612582 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-11-03

No results posted yet for this study

Summary

Research Objective:At present, there is no standard therapeutic regimen for monoclonal immunoglobulin light chain (AL) amyloidosis in the world. To compare the efficacy and safety of the regimens between bortezomib-thalidomide-dexamethasone (BTD) and bortezomib-cyclophosphamide-dexamethasone (BCD) in the treatment of AL amyloidosis, so as to provide more clinical evidence for the standard treatment for the disease.

Research Design:This study was designed as a prospective, randomized and controlled clinical study. Patients who meet the inclusion criteria of this study will be randomized to the BTD scheme group or BCD scheme group.

Conditions

  • Immunoglobulin Light-Chain Amyloidosis

Interventions

DRUG

Thalidomide

Bortezomib (d 1, 8, 15, 22, 1.3mg /m2, subcutaneous injection); thalidomide (d 1-28 50-100mg, oral); dexamethason (d 1, 2, 8, 9, 15, 16, 22, 23, 20mg, oral/intravenous injection) as a course of treatment, the patients will complete six courses of treatment after entering the group, and the total observation time is one year after the end of treatment.

DRUG

Cyclophosphamide

Bortezomib (d 1, 8, 15, 22,1.3mg / m2, subcutaneous injection); cyclophosphamide (d 1, 2,900mg / m2, intravenous drip); dexamethason (d 1, 2, 8, 9,15, 16, 22, 23, 20mg, oral/intravenous injection) as a course of treatment, patients will complete six courses of treatment after entering the group, the overall observation time is one year after the end of treatment.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Wenjian Wang, PhD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-01-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT04612582 on ClinicalTrials.gov