Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482261
Status:
UNKNOWN
Last Update Posted:
2013-01-10
First Post:
2007-06-03
Brief Title:
A Study of Low Dose Lenalidomide and Dexamethasone in RelapsedRefractory Myeloma in Patients at High Risk for Myelosuppression
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
Phase II Trial of Low Dose Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Rev-Lite in Patients at High Risk for Myelosuppression
Status:
UNKNOWN
Status Verified Date:
2013-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to see whether combination of low dose lenalidomide10mg dexamethasone is equally effective in treating relapsedrefractory myeloma in the group of elderly patients and other patients at risk of myelosuppression whilst producing less side effects especially myelosuppression compared to the higher dose of lenalidomide of 25mg used in the MM-009 and MM-010 trials
Detailed Description:
Lenalidomide has proven efficacy in myeloma In the Phase I studies with lenalidomide monotherapy responses were observed at doses of 5mg 10mg and 25mg The dose limiting toxicity of lenalidomide monotherapy was myelosuppression
In the International MM-010 and MM-009 studies lenalidomide was administered at 25mg d1-d21 with pulse dexamethasone of a 28 day cycle Although the overall response rate and time to progression were impressive a significant toxicity was myelosuppression The average age in these 2 studies was approximately 63 years some 7 years lower than the median age for myeloma The median number of prior therapies was 2 Thus if lenalidomide therapy is to be optimally applied in an older andor more heavily pre-treated population a simpler less toxic regimen would be valuable Low dose 15mg lenalidomide Rev-Lite with dexamethasone may achieve this goal
Based on analysis of the MM009 and MM010 data the patients at highest risk for myelosuppression and subsequent dose reduction were those over the age of 60 years approx 30 risk which increased to approx 50 by 70 yearsIt is hypothesized that patients with lower base-line platelets may also be at higher risk of lenalidomide-induced myelosuppression Little is known about lenalidomide tolerance in patients with impaired renal function consequently patients with relatively poorer renal function will also be enrolled into this study
In the International MM-010 and MM-009 studies lenalidomide was administered at 25mg d1-d21 with pulse dexamethasone of a 28 day cycle Although the overall response rate and time to progression were impressive a significant toxicity was myelosuppression The average age in these 2 studies was approximately 63 years some 7 years lower than the median age for myeloma The median number of prior therapies was 2 Thus if lenalidomide therapy is to be optimally applied in an older andor more heavily pre-treated population a simpler less toxic regimen would be valuable Low dose 15mg lenalidomide Rev-Lite with dexamethasone may achieve this goal
Based on analysis of the MM009 and MM010 data the patients at highest risk for myelosuppression and subsequent dose reduction were those over the age of 60 years approx 30 risk which increased to approx 50 by 70 yearsIt is hypothesized that patients with lower base-line platelets may also be at higher risk of lenalidomide-induced myelosuppression Little is known about lenalidomide tolerance in patients with impaired renal function consequently patients with relatively poorer renal function will also be enrolled into 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 |
|---|---|---|---|
| 0704 | None | None | None |