Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2006-09-18
Brief Title:
Bortezomib Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
An Open-Label Phase III Study of the Safety and Efficacy of Bortezomib Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
The purpose of this study is to determine the safety and efficacy of the bortezomib lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients
Detailed Description:
The safe dose of dexamethasone is already known The dose of bortezomib and lenalidomide will be increased during the study until the best and safest amount or dose is identified The participants dose of the study drugs will depend on when they enter the study
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1 Lenalidomide capsules will be taken daily for the first 2 weeks only Day 1-14 Dexamethasone tablets will be taken on Day 1 2 4 5 8 9 11 and 12 Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1 4 8 and 11 The third week is a rest period and no study medication will be given
During the course of the study treatment tests and procedures will be performed at designated time periods This includes medical history updates physicalneurological examinations skeletal survey x-rays or scan blood samples optional bone marrow aspirationtissue biopsy urine samples 12-lead ECG and MRICT scan if needed
It is expected that study participants will receive study treatment for 8 cycles 168 days If the participant completes the first 8 cycles of the study has stable or responding disease and has not experienced bad side effects they will be allowed to continue treatment on a maintenance schedule detailed in the protocol at the study doctors discretion
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1 Lenalidomide capsules will be taken daily for the first 2 weeks only Day 1-14 Dexamethasone tablets will be taken on Day 1 2 4 5 8 9 11 and 12 Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1 4 8 and 11 The third week is a rest period and no study medication will be given
During the course of the study treatment tests and procedures will be performed at designated time periods This includes medical history updates physicalneurological examinations skeletal survey x-rays or scan blood samples optional bone marrow aspirationtissue biopsy urine samples 12-lead ECG and MRICT scan if needed
It is expected that study participants will receive study treatment for 8 cycles 168 days If the participant completes the first 8 cycles of the study has stable or responding disease and has not experienced bad side effects they will be allowed to continue treatment on a maintenance schedule detailed in the protocol at the study doctors discretion
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