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Completed Phase 1 Interventional

A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

ClinicalTrials.gov ID: NCT01248923

Public ClinicalTrials.gov record NCT01248923. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 5:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Study identification

NCT ID
NCT01248923
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
55 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2010
Primary completion
Feb 29, 2016
Completion
Not listed
Last update posted
Sep 29, 2020

Started 2010

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Clearview Cancer Institute Huntsville Alabama 35805
Arizona Clinical Research Center, Inc. Tucson Arizona 85715
City of Hope Duarte California 91010
Emory University, Winship Cancer Institute Atlanta Georgia 30322
Associates in Oncology/Hematology Rockville Maryland 20850
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109
Karmanos Cancer Institute Detroit Michigan 48201
NYU Cancer Center New York New York 10016
Mount Sinai Medical Center New York New York 10029
Charleston Hematology Oncology Associates Charleston South Carolina 29414
The Jones Clinic Germantown Tennessee 38138
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37212
Baylor Charles A. Sammons Cancer Center at Dallas Dallas Texas 75246

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01248923, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 29, 2020 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01248923 live on ClinicalTrials.gov.

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