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A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma

NCT01989325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-09-16

No results posted yet for this study

Summary

This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.

Conditions

  • Advanced Multiple Myeloma

Interventions

DRUG

Carfilzomib, proteasome inhibitor; intravenous

multiple dose, single schedule

DRUG

Filanesib, KSP(Eg5) inhibitor; intravenous

multiple dose, single schedule

DRUG

Dexamethasone, steroid; oral or intravenous

as indicated, per the carfilzomib prescribing information

DRUG

Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

standard of care

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-02-29
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01989325 on ClinicalTrials.gov