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

NCT ID: NCT01273844

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-01
• Study Completion Date: 2016-05-12

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.

Detailed 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.

Conditions

Amyloidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bortezomib

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.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib

Interventions

Bortezomib

Bortezomib

Intervention Type: DRUG

Other Intervention Names

autologous hematopoietic stem cell transplantation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soochow University

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Zhi-Hong Liu, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Zhi-Hong Liu, M.D.

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

zhihong Liu, Master

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

NJCT-1006

Identifier Type: -

Identifier Source: org_study_id