NCT01372540

Filanesib and Carfilzomib in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

A Phase I Study of Arry-520 and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• 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 filanesib when given together with carfilzomib in treating patients with multiple myeloma or plasma cell leukemia that has returned or does not respond to treatment. Drugs used in chemotherapy, such as filanesib, 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. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filanesib together with carfilzomib may be a better treatment for multiple myeloma or plasma cell leukemia.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and the maximum-tolerated dose (MTD) of filanesib (ARRY-520) when combined with carfilzomib. SECONDARY OBJECTIVES: I. To obtain preliminary estimates of the efficacy of ARRY-520 when combined with carfilzomib. II. To explore potential markers for patient selection and obtain a preliminary assessment of the biological activity of ARRY-520 when combined with carfilzomib. OUTLINE: This is a dose-escalation study. Patients receive filanesib intravenously (IV) over 1 hour on days 1, 2, 15, and 16 and carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 8 courses of therapy, patients may continue with dosing of carfilzomib on days 1, 2, 15, and 16 and filanesib as tolerated. If patient progresses on carfilzomib maintenance with administration on days 1, 2, 15, and 16 they may increase the intensity and add in days 8 and 9 dosing. After completion of study treatment, patients are followed up within 30 days and then periodically thereafter.

Conditions

• Plasma Cell Leukemia
• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Given IV
DRUG	Filanesib	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-02-24
• Primary completion: 2019-05-16
• Completion: 2019-05-16
• First posted: 2011-06-14
• Last updated: 2019-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study