Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305812
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2006-03-21
Brief Title:
Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase II Dose Finding Study of Revlimid and Melphalan in Patients With Previously Untreated Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2020-03
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 Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer It may also stimulate the immune system in different ways and stop cancer cells from growing Drugs used in chemotherapy such as melphalan work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving lenalidomide together with melphalan may kill more cancer cells
PURPOSE This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma
PURPOSE This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation
Secondary
Characterize the toxicity profile of lenalidomide in combination with melphalan
Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone
Determine progression-free and overall survival of these patients
Determine time to dose modification and time to dose discontinuation in these patients
Tertiary
Examine wnt pathway inhibition in response to lenalidomide on pre- and post-treatment bone marrow and blood samples using enzyme-linked immunosorbent assay ELISA gene expression profiling drosophila-based chemical genetics and surface-enhanced laser desorptionionization mass spectrometry SELDI MS proteomics
OUTLINE This is a multicenter randomized open-label dose-finding study of lenalidomide
Prior to randomization 6 patients receive oral lenalidomide at a lower dose same dose to be used in arm I once daily on days 1-21 and oral melphalan once daily on days 1-4 Treatment repeats every 28 days for 3 courses If no unacceptable toxicity occurs the trial will proceed and randomization will occur
Induction therapy Patients are randomized to 1 of 2 dose levels of lenalidomide
Arm I Patients receive oral lenalidomide once daily on days 1-21 and oral melphalan once daily on days 1-4
Arm II Patients receive oral lenalidomide as in arm I but at a lower dose and melphalan as in arm I but at a higher dose
Treatment in both arms repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity After 12 courses of induction therapy patients in both arms without progressive disease proceed to maintenance therapy
Maintenance therapy Patients receive oral dexamethasone once daily on days 1-4 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A total of 92 patients will be accrued for this study
Primary
Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation
Secondary
Characterize the toxicity profile of lenalidomide in combination with melphalan
Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone
Determine progression-free and overall survival of these patients
Determine time to dose modification and time to dose discontinuation in these patients
Tertiary
Examine wnt pathway inhibition in response to lenalidomide on pre- and post-treatment bone marrow and blood samples using enzyme-linked immunosorbent assay ELISA gene expression profiling drosophila-based chemical genetics and surface-enhanced laser desorptionionization mass spectrometry SELDI MS proteomics
OUTLINE This is a multicenter randomized open-label dose-finding study of lenalidomide
Prior to randomization 6 patients receive oral lenalidomide at a lower dose same dose to be used in arm I once daily on days 1-21 and oral melphalan once daily on days 1-4 Treatment repeats every 28 days for 3 courses If no unacceptable toxicity occurs the trial will proceed and randomization will occur
Induction therapy Patients are randomized to 1 of 2 dose levels of lenalidomide
Arm I Patients receive oral lenalidomide once daily on days 1-21 and oral melphalan once daily on days 1-4
Arm II Patients receive oral lenalidomide as in arm I but at a lower dose and melphalan as in arm I but at a higher dose
Treatment in both arms repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity After 12 courses of induction therapy patients in both arms without progressive disease proceed to maintenance therapy
Maintenance therapy Patients receive oral dexamethasone once daily on days 1-4 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A total of 92 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000466184 | OTHER | PDQ | None |
| CAN-NCIC-MY11 | OTHER | None | None |
| CELGENE-CAN-NCIC-MY11 | OTHER | None | None |