NCT01198067

Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia

Phase I Study of Pomalidomide in Relapsed or Refractory Waldenstrom Macroglobulinemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Waldenstrom Macroglobulinemia
• Refractory Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2010-10-06
• Primary completion: 2025-05-02
• Completion: 2025-05-02
• First posted: 2010-09-09
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study