NCT01536067

Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia

A Multicenter Phase II Study of Ofatumumab and Bortezomib (OB) in Previously Untreated Patients With Waldenstrom Macroglobulinemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving ofatumumab together with bortezomib may be a better way to block cancer growth

Detailed description

PRIMARY OBJECTIVES: I. Determine overall response rate (complete response \[CR\] + partial response \[PR\] + minor response \[MR\]) of ofatumumab in combination with bortezomib. SECONDARY OBJECTIVES: I. Determine complete remission (CR) rate, near (n)CR rate, very good partial response (VGPR) rate and PR rate per new criteria. II. Determine 5 year progression free survival (PFS). III. Determine time to progression and duration of response of ofatumumab in conjunction with bortezomib. IV. Determine safety of ofatumumab in combination with bortezomib. V. Conduct laboratory correlates. OUTLINE: INDUCTION PHASE: Patients receive ofatumumab intravenously (IV) on days 1, 8, and 15 and bortezomib subcutaneously (SC) on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 5 years.

Conditions

• Waldenström Macroglobulinemia

Interventions

Type	Name	Description
BIOLOGICAL	ofatumumab	Given IV
DRUG	bortezomib	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-04-01
• First posted: 2012-02-20
• Last updated: 2016-06-10
• Results posted: 2016-06-10

Locations

2 sites across 1 country: United States