Viewing Study NCT00417911



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Study NCT ID: NCT00417911
Status: COMPLETED
Last Update Posted: 2010-06-22
First Post: 2007-01-03

Brief Title: Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients
Sponsor: Nordic Myeloma Study Group
Organization: Nordic Myeloma Study Group

Study Overview

Official Title: Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support A Randomised NMSG Trial 1505
Status: COMPLETED
Status Verified Date: 2010-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support ASCT in younger patients However the disease will eventually relapse and new treatment is demanded Bortezomib is a newly approved drug for treating relapsing multiple myeloma It has a different biological effect and response even in patients refractory to conventional chemotherapy The purpose of the study is in a randomized design to investigate if addition of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can prolong the time to progression compared to patients receiving no consolidation or maintenance therapy
Detailed Description: Rationale

ASCT prolongs EFS and OS for myeloma patients 65 years of age During the period from ASCT to progression most myeloma patients experience few symptoms and have a good quality of life11 A further prolongation of EFS would be a big step forward in myeloma treatment Bortezomib is a new promising agent which has shown clear anti-myeloma effect in heavily pre-treated patients After ASCT the tumour cell burden is low and it is the hypothesis of this clinical trial that the unique mechanism of action of bortezomib may reduce the number of tumour cells even further and by doing so prolong EFS

Primary objective

Evaluate the effect on EFS an event is defined as either progression or death of any cause without preceding progression of consolidation treatment with bortezomib after ASCT compared to no consolidation

Secondary objectives

Overall survival from ASCT
Overall survival from start of relapse treatment
Time to need for relapse treatment
Response rate in patients not in CR following ASCT
Toxicity from consolidation treatment
Quality of life
Cost utility
Planned subgroup analysis comparison of primary and secondary endpoint in patients receiving one vs two high dose treatments

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
EudraCT No 2005-002756-18 None None None