NCT02944565

Daratumumab in Treating Patients With Multiple Myeloma

Daratumumab Infusion Acceleration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well daratumumab works in treating patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and tolerability of decreasing the infusion time of daratumumab in patients that have already received 2+ doses of daratumumab and are continuing on daratumumab. II. Estimate the time savings versus (vs) predicted infusion time. OUTLINE: Patients receive daratumumab intravenously (IV) over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Daratumumab	Given IV

Timeline

• Start date: 2017-02-22
• Primary completion: 2017-07-20
• Completion: 2017-07-20
• First posted: 2016-10-26
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study