NCT01646762

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel (Abraxane) (paclitaxel albumin-stabilized nanoparticle formulation) in patients with relapsed or refractory multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the adverse events associated with use of single agent nab-paclitaxel (Abraxane) in patients with relapsed or refractory multiple myeloma. II. To evaluate overall survival, time to progression, and duration of response among patients with relapsed or refractory multiple myeloma undergoing treatment with single agent nab-paclitaxel (Abraxane). OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for up to 3 years.

Conditions

• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Paclitaxel Albumin-Stabilized Nanoparticle Formulation	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-11-05
• Primary completion: 2015-01-15
• Completion: 2015-10-27
• First posted: 2012-07-20
• Last updated: 2017-10-16
• Results posted: 2017-09-01

Locations

1 site across 1 country: United States