Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis

Phase 2

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Drug: bortezomib; Drug: dexamethasone

• Registration Number: NCT00458822
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-01-04
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Results First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	bortezomib	All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
All Patients	dexamethasone	All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis

Primary Outcome Measures

Name	Time	Method
Hematologic and Organ Response	2-3 months post transplant	patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States