NCT01273844

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Zhi-Hong Liu, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-05-12
• Completion: 2016-05-12
• First posted: 2011-01-11
• Last updated: 2017-04-07

Locations

1 site across 1 country: China