Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432458
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2007-02-05
Brief Title:
Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase III Randomized Trial of Thalidomide Plus Zoledronic Acid Versus Zoledronic Acid Alone in Patients With Early Stage Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Zoledronate may prevent bone loss and stop the growth of cancer cells in bone Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma
PURPOSE This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma
PURPOSE This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Compare time to progression in patients with early stage multiple myeloma treated with zoledronate with or without thalidomide
Secondary
Compare the response rate 1-year progression-free survival rate duration of response and time to next therapy in patients treated with these regimens
Assess differences in toxicity of these regimens in these patients
OUTLINE This is a multicenter randomized study Patients are stratified according to the presence of lytic lesions on metastatic bone survey yes vs no beta-2 microglobulin level high vs normal and bone marrow labeling index high 10 vs low 10 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral thalidomide on days 1-28 Treatment with thalidomide repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive zoledronate IV over 15 minutes on day 1 Treatment with zoledronate repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity
Arm II Patients receive zoledronate IV over 15 minutes on day 1 Treatment repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity
Blood samples are collected for research studies at baseline and after courses 3 6 9 and 12 Bone marrow aspirates are performed at baseline and after courses 6 and 12 Samples are evaluated for bone marrow angiogenesis vascular endothelial growth factor VEGF VEGF receptor 1 VEGFR-1 and VEGFR-2 expression bone marrow angiogenesis-VEGF relationship bone marrow angiogenesisapoptosis rate relationship bone marrow angiogenesisplasma cell PC proliferation rate relationship VEGF expressionapoptosis rate relationship and VEGFR expressionPC proliferation rate relationship
After completion of study treatment patients are followed every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
Primary
Compare time to progression in patients with early stage multiple myeloma treated with zoledronate with or without thalidomide
Secondary
Compare the response rate 1-year progression-free survival rate duration of response and time to next therapy in patients treated with these regimens
Assess differences in toxicity of these regimens in these patients
OUTLINE This is a multicenter randomized study Patients are stratified according to the presence of lytic lesions on metastatic bone survey yes vs no beta-2 microglobulin level high vs normal and bone marrow labeling index high 10 vs low 10 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral thalidomide on days 1-28 Treatment with thalidomide repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive zoledronate IV over 15 minutes on day 1 Treatment with zoledronate repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity
Arm II Patients receive zoledronate IV over 15 minutes on day 1 Treatment repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity
Blood samples are collected for research studies at baseline and after courses 3 6 9 and 12 Bone marrow aspirates are performed at baseline and after courses 6 and 12 Samples are evaluated for bone marrow angiogenesis vascular endothelial growth factor VEGF VEGF receptor 1 VEGFR-1 and VEGFR-2 expression bone marrow angiogenesis-VEGF relationship bone marrow angiogenesisapoptosis rate relationship bone marrow angiogenesisplasma cell PC proliferation rate relationship VEGF expressionapoptosis rate relationship and VEGFR expressionPC proliferation rate relationship
After completion of study treatment patients are followed every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
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 |
|---|---|---|---|
| 421-03 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC0289 | OTHER | None | None |