MedTrace Logo

Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients

NCT00983346 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-07-11

Study results available
· View outcomes & findings →

Summary

OBJECTIVES

* Primary: To evaluate the bone anabolic effect of bortezomib in patients with smoldering myeloma.
* Secondary: To evaluate the effect of bortezomib on the natural history of smoldering myeloma.

Conditions

Interventions

DRUG

Bortezomib

Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle. Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.

Sponsors & Collaborators

Principal Investigators

  • Maurizio Zangari, MD · University of Utah

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00983346 on ClinicalTrials.gov