Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT01198067
Status:
TERMINATED
Last Update Posted:
2025-09-04
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study of Pomalidomide in Relapsed or Refractory Waldenstrom Macroglobulinemia
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
\<75% participant accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of pomalidomide in treating patients with Waldenstrom macroglobulinemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Pomalidomide may stimulate the immune system in different ways and stop cancer cells from growing.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of pomalidomide in patients with relapsed or refractory Waldenstrom macroglobulinemia.
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity profile of pomalidomide in patients with relapsed or refractory Waldenstrom macroglobulinemia.
II. To evaluate the efficacy of pomalidomide in patients with relapsed or refractory Waldenstrom macroglobulinemia.
OUTLINE: This is a dose-escalation study.
Patients receive pomalidomide orally (PO) on days 1-28 or 1-21. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
I. To determine the maximum tolerated dose (MTD) of pomalidomide in patients with relapsed or refractory Waldenstrom macroglobulinemia.
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity profile of pomalidomide in patients with relapsed or refractory Waldenstrom macroglobulinemia.
II. To evaluate the efficacy of pomalidomide in patients with relapsed or refractory Waldenstrom macroglobulinemia.
OUTLINE: This is a dose-escalation study.
Patients receive pomalidomide orally (PO) on days 1-28 or 1-21. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: