Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

NCT02485613 | Completed

• 1 other identifier: NJCT-1501
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Hematologic response rate

  Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis

  3 months

Secondary Outcomes (3)

• organ response rate

  12 months

• Overall survival

  From date of the start of treatment to date of death,up to 3 months

• Progression free survival

  From date of the start of treatment to date of disease progression,up to 3 months

Study Arms (1)

bortezominb and dexamethasone group

Drug: bortezominb and dexamethasone

Interventions

bortezominb and dexamethasone DRUG

The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.

Also known as: Velcade

bortezominb and dexamethasone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.

You may qualify if:

• Female or male patients aged between 18 to 80 years
• Renal or other type biopsy was used to diagnose AL amyloidosis
• Understand and voluntarily sign an informed consent form
• ECOG score 0-3 points
• Adequate residual organ function

You may not qualify if:

• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Grade 3 sensory or grade 1 painful peripheral neuropathy
• Known hypersensitivity to bortezomib, boron or mannitol
• Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
• Clinically overt multiple myeloma
• Pregnant or nursing women.

Sponsors & Collaborators

• Zhi-Hong Liu, M.D.: lead

MeSH Terms

Conditions

Amyloidosis

Interventions

Dexamethasone; Bortezomib

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 30, 2015
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2015-06