Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
Study NCT ID:
NCT01706666
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2012-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase II Randomized Study of Three Subcutaneous Bortezomib-based Consolidation Treatments for Patients Completing Induction Therapy and Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2018-08
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:
This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.
Detailed Description:
PRIMARY OBJECTIVES:
I. To compare the stringent complete response (sCR) rate after 12 cycles among arms.
SECONDARY OBJECTIVES:
I. To compare progression-free and overall survival among arms. II. To describe the adverse event profile of each arm.
TERTIARY OBJECTIVES:
I. To compare sCR after 6 cycles and 24 cycles and quality of life among arms.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A: Patients receive bortezomib subcutaneously (SC) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally (PO) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
ARM C: Patients receive bortezomib SC as in Arm A and lenalidomide PO once daily (QD) on days 1-28.
In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years.
I. To compare the stringent complete response (sCR) rate after 12 cycles among arms.
SECONDARY OBJECTIVES:
I. To compare progression-free and overall survival among arms. II. To describe the adverse event profile of each arm.
TERTIARY OBJECTIVES:
I. To compare sCR after 6 cycles and 24 cycles and quality of life among arms.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A: Patients receive bortezomib subcutaneously (SC) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally (PO) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
ARM C: Patients receive bortezomib SC as in Arm A and lenalidomide PO once daily (QD) on days 1-28.
In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01579 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |