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Panobinostat/Velcade in Multiple Myeloma

NCT00891033 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-02-23

No results posted yet for this study

Summary

Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of hematological tumors, representing the second most frequently occurring hematological malignancy in the United States. At any one time, 50,000 people suffer from MM, and approximately 15,000 are diagnosed each year. The median age is approximately 65 years, although occasionally MM occurs in the second decade of life.

Bortezomib and panobinostat intravenous (IV) are active agents in multiple myeloma and appear to work through different biochemical pathways, suggesting that there may be a synergistic effect using the combination. Both compounds have shown anabolic bone effect, which has been associated to significant anti-myeloma activity.

Primary objectives:

* To assess the toxicity of bortezomib combined with one of 4 doses of panobinostat IV in patients with relapsed/refractory multiple myeloma, and
* To find the most appropriate doses of bortezomib and panobinostat IV in the combination.

Secondary objective:

* To assess the effect of bortezomib in combination with panobinostat IV on inducing osteoblast activation in patients with relapsed/refractory myeloma.

Conditions

Interventions

DRUG

Bortezomib (Velcade)

During the study Bortezomib will be administered intravenously as a 3-5 second bolus IV injection, at a dose of 1.0 mg/m2 on days 1, 4, 8, and 11 of each 21-day treatment cycle.

DRUG

Panobinostat

During the study, panobinostat IV will be administered intravenously as once daily on (day 1 and 8 of the 21 day cycle 2 and beyond). Patients enrolled on first group will receive 5 mg/m2 panobinostat IV, second group 10 mg/m2 panobinostat IV, third group 15 mg/m2 panobinostat IV and the fourth group 20 mg/m2 panobinostat IV. Each infusion of panobinostat will be administered over 30 minutes.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Mauizio Zangari, MD · University of Utah

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT00891033 on ClinicalTrials.gov