Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098475
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2004-12-07
Brief Title:
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone given with or without thalidomide in treating patients with multiple myeloma Biological therapies such as lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer Drugs used in chemotherapy such as dexamethasone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving lenalidomide thalidomide and dexamethasone together may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the response rate and toxicity of lenalidomide CC-5013 plus dexamethasone standard dose versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity First Phase
SECONDARY OBJECTIVES
I To evaluate the response rate of thalidomide plus dexamethasone ThalDex in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms First Phase
II To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade on plasma cell labeling index PCLI and on the expression of vascular endothelial growth factor VEGF and basic fibroblast growth factor bFGF in the marrow First Phase
III To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells MPCs First Phase
IV To evaluate in a separate expansion phase the efficacy of aspirin 325 mgday versus Coumadin dose adjusted to maintain a target international normalized ratio INR of 2-3 in preventing deep vein thrombosis DVT in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive lenalidomide orally PO once daily QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4 9-12 and 17-20
Arm II Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1 8 15 and 22
In both arms cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively
Arm III patients with no response after treatment on Arm I Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4 9-12 and 17-20
Arm IV patients with no response after treatment on Arm II Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1 8 15 and 22
In both salvage therapy arms cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression After completion of 4 cycles of therapy patients may undergo stem cell harvest using growth factors only for cryopreservation
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually for 2 years
I To evaluate the response rate and toxicity of lenalidomide CC-5013 plus dexamethasone standard dose versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity First Phase
SECONDARY OBJECTIVES
I To evaluate the response rate of thalidomide plus dexamethasone ThalDex in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms First Phase
II To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade on plasma cell labeling index PCLI and on the expression of vascular endothelial growth factor VEGF and basic fibroblast growth factor bFGF in the marrow First Phase
III To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells MPCs First Phase
IV To evaluate in a separate expansion phase the efficacy of aspirin 325 mgday versus Coumadin dose adjusted to maintain a target international normalized ratio INR of 2-3 in preventing deep vein thrombosis DVT in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive lenalidomide orally PO once daily QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4 9-12 and 17-20
Arm II Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1 8 15 and 22
In both arms cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively
Arm III patients with no response after treatment on Arm I Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4 9-12 and 17-20
Arm IV patients with no response after treatment on Arm II Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1 8 15 and 22
In both salvage therapy arms cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression After completion of 4 cycles of therapy patients may undergo stem cell harvest using growth factors only for cryopreservation
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually for 2 years
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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-03150 | REGISTRY | None | None |
| E4A03 | None | None | None |
| CDR0000404161 | None | None | None |
| E4A03 | OTHER | None | None |
| E4A03 | OTHER | None | None |
| U10CA180820 | NIH | None | None |