Ignite Creation Date:
2024-05-05 @ 10:43 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01177683
Status:
TERMINATED
Last Update Posted:
2023-10-06
First Post:
2010-08-05
Brief Title:
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
Sponsor:
Sherif Farag MB BS
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase III Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma Hoosier Cancer Research Network MM08-141
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label phase III trial to determine the safety and the biologic activity of the bendamustine bortezomib and pegylated liposomal doxorubicin combination
Detailed Description:
Phase I component Bortezomib 13 mgm2 IV bolus Days 1 4 8 and 11 Doxorubicin 30 mgm2 IV over 1 hour Day 4 Bendamustine escalating cohorts IV over 1 hour Days 1 and 4 1 Cycle 28 days
Phase II component Bortezomib 13 mgm2 IV bolus Days 1 4 8 and 11 Doxorubicin 30 mgm2 IV over 1 hour Day 4 Bendamustine at MTD IV over 1 hour Days 1 and 4 Filgrastim if defined in MTD 5 µgkgday SC Starting day 6 until neutrophil recovery to ANC 1000
1 Cycle 28 days Patients will continue treatment for a total of up to 8 cycles
ECOG Performance Status 0-2
Hematopoietic
Absolute neutrophil count ANC 12 x Kmm3
Platelets 75 x Kmm3
Hepatic
Total bilirubin 15 x upper limit of normal ULN
AST 25 x ULN
ALT 25 x ULN
Renal
Serum creatinine 30 mgdL
Cardiovascular
LVEF 45 corrected by MUGA scan or echocardiogram
No unstable angina pectoris or recent myocardial infarction within 6 months
Phase II component Bortezomib 13 mgm2 IV bolus Days 1 4 8 and 11 Doxorubicin 30 mgm2 IV over 1 hour Day 4 Bendamustine at MTD IV over 1 hour Days 1 and 4 Filgrastim if defined in MTD 5 µgkgday SC Starting day 6 until neutrophil recovery to ANC 1000
1 Cycle 28 days Patients will continue treatment for a total of up to 8 cycles
ECOG Performance Status 0-2
Hematopoietic
Absolute neutrophil count ANC 12 x Kmm3
Platelets 75 x Kmm3
Hepatic
Total bilirubin 15 x upper limit of normal ULN
AST 25 x ULN
ALT 25 x ULN
Renal
Serum creatinine 30 mgdL
Cardiovascular
LVEF 45 corrected by MUGA scan or echocardiogram
No unstable angina pectoris or recent myocardial infarction within 6 months
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