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

Amyloidosis Clinical Trial

Official title:

Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273844
• Other study ID #: NJCT-1006
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: April 5, 2017
• Start date: March 1, 2011
• Est. completion date: May 12, 2016

Study information

• Verified date: April 2017
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. After two cycles of vel / dex therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and platelet count> 50x109/L). Later patients won't need maintenance therapy.

The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 12, 2016
• Est. primary completion date: May 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female;

2. aged 18-65 years;

3. Patients with newly diagnosed AL;

4. Appropriate for autologous hematopoietic stem cell transplantation;

5. Abnormal M protein or free light chain detected in serum and / or urine

6. ECOG score 0-2 points;

7. 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.

Exclusion Criteria:

1. Subjects received systematic treatment with steroids

2. Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.

3. Pregnant and breastfeeding women;

4. Subjects suffering from multiple myeloma.

5. hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);

6. Subjects have severe cardiovascular disease,

7. Subjects have serious physical disease and mental illnesses which may interfere the study

Related Conditions & MeSH terms

• Amyloidosis

Intervention

Drug:
• Bortezomib
Bortezomib

Locations

Country	Name	City	State
China	Soochow University	Suzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.	Nanjing Medical University, Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	progression-free survival	progression-free survival (PFS) at 2 years post-transplantation	2 years
Primary	Complete response rate	Complete response rate at 12 months post-transplantation	12 months
Secondary	overall response rate	overall response rate(ie.,CR + PR) at 12 months post-transplantation	12 months