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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273844

Enrollment

Registered

2011-01-11

Start date

2011-03-01

Completion date

2016-05-12

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis

Keywords

hematopoietic stem cell transplantation, amyloidosis, Bortezomib

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.

Interventions

DRUGBortezomib

Bortezomib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete response rate	12 months	Complete response rate at 12 months post-transplantation

Secondary

Measure	Time frame	Description
overall response rate	12 months	overall response rate(ie.,CR + PR) at 12 months post-transplantation

Other

Measure	Time frame	Description
progression-free survival	2 years	progression-free survival (PFS) at 2 years post-transplantation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026