Ignite Creation Date:
2024-05-05 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00734149
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2007-12-26
Brief Title:
Bortezomib With Melphalan and Prednisone for Multiple Myeloma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Prospective Study of Bortezomib in Combination With Melphalan and Prednisone for Patients With Previously Untreated Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-03
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:
MVP
Brief Summary:
The purpose of this study is to assess the efficacy of bortezomib in combination with melphalan and prednisone to achieve complete responses for patients with previously untreated multiple myeloma compared to an historical control group This trial will also evaluate the safety and toxicity of this regimen as well as evaluate the duration of response of this regimen
Detailed Description:
Based on the need to improve front-line therapy for patients less likely to undergo transplant the promising recent in vitro and clinical work on melphalan and bortezomib we propose a prospective trial with bortezomib added to standard melphalan and prednisone therapy for previously untreated patients with multiple myeloma Bortezomib 13 mgm2 will be given twice weekly for two weeks and will be added to standard melphalan and prednisone on a 4-week cycle This three-drug combination will be compared to historical data We have treated 2 patients with relapsed disease following 2 prior regimens including high-dose therapy with autologous stem cell support Each patient received melphalan prednisone and bortezomib as described below and both had marked declines in M-protein within 2 cycles These responses have been sustained for at least 3 months and treatment was well tolerated
Eligible patients will have histologically confirmed Multiple Myeloma MM having not received prior systemic therapy given with the intent to induce remission be adults have life expectancy greater than 3 months adequate performance status organ and marrow function as described in the protocol not be pregnant HIV positive or taking any investigational agents Patients must not have history of allergic reactions to study drugs or similar compounds or have uncontrolled intercurrent illness or social situation that would limit compliance with study requirements Patients must also have the ability to give informed consent
Study drugs will be administered on an inpatient or outpatient basis Bortezomib 13 mgm2 is administered intravenously in a 3-5 second bolus on days 1 4 8 and 11 of a 28 day cycle Six cycles are planned On days when both melphalan and bortezomib are given melphalan is given at least one hour prior to bortezomib Melphalan 6 mgm2 is administered orally on an empty stomach daily on days 1-7 of each cycle Prednisone 60 mgm2 is administered orally daily on days 1-7 of each cycle Supportive care measures such as antiemetics and growth factors may be given
Eligible patients will have histologically confirmed Multiple Myeloma MM having not received prior systemic therapy given with the intent to induce remission be adults have life expectancy greater than 3 months adequate performance status organ and marrow function as described in the protocol not be pregnant HIV positive or taking any investigational agents Patients must not have history of allergic reactions to study drugs or similar compounds or have uncontrolled intercurrent illness or social situation that would limit compliance with study requirements Patients must also have the ability to give informed consent
Study drugs will be administered on an inpatient or outpatient basis Bortezomib 13 mgm2 is administered intravenously in a 3-5 second bolus on days 1 4 8 and 11 of a 28 day cycle Six cycles are planned On days when both melphalan and bortezomib are given melphalan is given at least one hour prior to bortezomib Melphalan 6 mgm2 is administered orally on an empty stomach daily on days 1-7 of each cycle Prednisone 60 mgm2 is administered orally daily on days 1-7 of each cycle Supportive care measures such as antiemetics and growth factors may be given
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 |
|---|---|---|---|
| 6019 | OTHER | old IRB number | None |