A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma

June 7, 2006 updated by: Pharmacyclics LLC.

An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma

The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Relapsed or Refractory Multiple Myeloma
  • ≥ 18 years old
  • Able to provide consent for participation
  • ECOG status 0-2

Lab values:

  • ANC ≥ 1,000/µL
  • WBC count ≥ 2.0/µL
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 50,000/µL
  • AST and ALT ≤ 2 x ULN
  • Total Bilirubin ≤ 2 x ULN
  • Creatinine ≤ 2.0 mg/dL

and

  • Not pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of complete response, partial response and stable disease (clinical benefit rate)

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Safety and tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 16, 2004

First Submitted That Met QC Criteria

November 16, 2004

First Posted (Estimate)

November 17, 2004

Study Record Updates

Last Update Posted (Estimate)

June 8, 2006

Last Update Submitted That Met QC Criteria

June 7, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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