Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179647
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
2005-09-13
Brief Title:
Expanded Access ProgramLenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Single-Arm Open-Label Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma
Detailed Description:
This was a multicenter non-randomized open-label uncontrolled single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma with measurable myeloma paraprotein in serum andor urine Subjects who met all of the eligibility criteria were enrolled into the study Screening procedures took place within 28 days of first dose Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days
Subjects had the following options for dexamethasone treatment at the discretion of the treating physician
Option A No dexamethasone
Option B Oral pulse dexamethasone administered at a dose of 40 mg daily on Days 1-4 9-12 and 17-20 for each 28-day cycle
Option C Oral pulse dexamethasone administered at a dose of 20 mg daily on Days 1-4 9-12 and 17-20 for each 28-day cycle
Option D Oral dexamethasone administered at a dose of 40 mg weekly on Days 1 8 15 and 22 for each 28-day cycle for all cycles Treatment was to be continued as tolerated until disease progression developed
Doses of lenalidomide were allowed to be reduced first from 25 mg to 15 mg and then in 5-mg decrements due to lenalidomide toxicity Subjects who could not tolerate a daily dose of 5 mg for 21 days every 28 days were discontinued from treatment At the discretion of the investigator doses of dexamethasone were modified due to dexamethasone toxicity Dose reduction and discontinuation schemes for dexamethasone varied according to the treatment option administered
Study visits occurred every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression was documented study drug was discontinued for another reason or lenalidomide became commercially available for this indication
Subjects had the following options for dexamethasone treatment at the discretion of the treating physician
Option A No dexamethasone
Option B Oral pulse dexamethasone administered at a dose of 40 mg daily on Days 1-4 9-12 and 17-20 for each 28-day cycle
Option C Oral pulse dexamethasone administered at a dose of 20 mg daily on Days 1-4 9-12 and 17-20 for each 28-day cycle
Option D Oral dexamethasone administered at a dose of 40 mg weekly on Days 1 8 15 and 22 for each 28-day cycle for all cycles Treatment was to be continued as tolerated until disease progression developed
Doses of lenalidomide were allowed to be reduced first from 25 mg to 15 mg and then in 5-mg decrements due to lenalidomide toxicity Subjects who could not tolerate a daily dose of 5 mg for 21 days every 28 days were discontinued from treatment At the discretion of the investigator doses of dexamethasone were modified due to dexamethasone toxicity Dose reduction and discontinuation schemes for dexamethasone varied according to the treatment option administered
Study visits occurred every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression was documented study drug was discontinued for another reason or lenalidomide became commercially available for this indication
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