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

Not Applicable

Completed

• Conditions: Amyloidosis
• Interventions: Drug: Bortezomib

• Registration Number: NCT01273844
• Lead Sponsor: Zhi-Hong Liu, M.D.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Study Start: 2011-03-01
• Primary Completion: 2016-05-12
• Study Completion: 2016-05-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bortezomib	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.

Primary Outcome Measures

Name	Time	Method
Complete response rate	12 months	Complete response rate at 12 months post-transplantation

Secondary Outcome Measures

Name	Time	Method
overall response rate	12 months	overall response rate(ie.,CR + PR) at 12 months post-transplantation

Trial Locations

Locations (1)

Soochow University; 🇨🇳 Suzhou, Jiangsu, China