Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114101
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2005-06-13
Brief Title:
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Double-Blind Study of Maintenance Therapy With CC-5013 NSC 703813 or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patients bone marrow for new blood-forming cells stem cells to grow After treatment stem cells are collected from the patients blood and stored More chemotherapy is then given to prepare the bone marrow for the stem cell transplant The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy Biological therapies such as lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of CC-5013 lenalidomide in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant ASCT
SECONDARY OBJECTIVES
I To determine if CC-5013 will increase the complete response CR rate in patients with multiple myeloma following ASCT
II To compare the progression-free survival PFS and overall survival OS in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo
III To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT
OUTLINE
PERIPHERAL BLOOD STEM CELL PBSC MOBILIZATION Mobilization of autologous PBSC will be performed according to institutional guidelines
AUTOLOGOUS PBSC TRANSPLANTATION PBSCT Patients receive melphalan intravenously IV over 30-60 minutes on day -2 or -1 or over 2 days on days -3 and -2 or -2 and -1 Patients undergo autologous PBSCT on day 0
Patients are then randomized to 1 of 2 maintenance treatment arms Note As of 121709 no more patients will be randomized between lenalidomide and placebo Patients who have not been randomized as of 121709 will be assigned to lenalidomide
ARM I Beginning between day 100-110 patients receive lenalidomide orally PO once daily
ARM II Beginning between day 100-110 patients receive placebo PO once daily
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year and then every 6 months thereafter
I To determine the efficacy of CC-5013 lenalidomide in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant ASCT
SECONDARY OBJECTIVES
I To determine if CC-5013 will increase the complete response CR rate in patients with multiple myeloma following ASCT
II To compare the progression-free survival PFS and overall survival OS in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo
III To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT
OUTLINE
PERIPHERAL BLOOD STEM CELL PBSC MOBILIZATION Mobilization of autologous PBSC will be performed according to institutional guidelines
AUTOLOGOUS PBSC TRANSPLANTATION PBSCT Patients receive melphalan intravenously IV over 30-60 minutes on day -2 or -1 or over 2 days on days -3 and -2 or -2 and -1 Patients undergo autologous PBSCT on day 0
Patients are then randomized to 1 of 2 maintenance treatment arms Note As of 121709 no more patients will be randomized between lenalidomide and placebo Patients who have not been randomized as of 121709 will be assigned to lenalidomide
ARM I Beginning between day 100-110 patients receive lenalidomide orally PO once daily
ARM II Beginning between day 100-110 patients receive placebo PO once daily
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year and then every 6 months thereafter
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 |
|---|---|---|---|
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |
| NCI-2009-00439 | REGISTRY | None | None |
| CALGB 100104ECOG 100104 | None | None | None |
| CDR0000434845 | None | None | None |
| CALGB-100104 | OTHER | None | None |
| CALGB-100104 | OTHER | None | None |
| U10CA180821 | NIH | None | None |