Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)

NCT01273844 | Completed DMC

• 1 other identifier: NJCT-1006
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.

Conditions

Amyloidosis

Keywords

hematopoietic stem cell transplantation; amyloidosis; Bortezomib

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate at 12 months post-transplantation

  12 months

Secondary Outcomes (1)

• overall response rate

  12 months

Other Outcomes (1)

• progression-free survival

  2 years

Study Arms (1)

Bortezomib

EXPERIMENTAL

Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4.

Drug: Bortezomib

Interventions

Bortezomib DRUG

Bortezomib

Also known as: autologous hematopoietic stem cell transplantation

Bortezomib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female;
• aged 18-65 years;
• Patients with newly diagnosed AL;
• Appropriate for autologous hematopoietic stem cell transplantation;
• Abnormal M protein or free light chain detected in serum and / or urine
• ECOG score 0-2 points;
• Subjects (or their legal representatives) must signed an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

You may not qualify if:

• Subjects received systematic treatment with steroids
• Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.
• Pregnant and breastfeeding women;
• Subjects suffering from multiple myeloma.
• hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);
• Subjects have severe cardiovascular disease,
• Subjects have serious physical disease and mental illnesses which may interfere the study

Sponsors & Collaborators

• Zhi-Hong Liu, M.D.: lead
• Soochow University: collaborator
• Nanjing Medical University: collaborator

Study Sites (1)

Soochow University

Suzhou, Jiangsu, 215325, China

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• zhihong Liu, Master

  Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 11, 2011
• Study Start: March 1, 2011
• Primary Completion: May 12, 2016
• Study Completion: May 12, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

CN (1)