Back to resultsA Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motexafin Gadolinium Injection
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Rate of complete response, partial response and stable disease (clinical benefit rate)
Secondary Outcome Measures
Progression-free survival
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00096837
Brief Title
A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma
Official Title
An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium Injection
Primary Outcome Measure Information:
Title
Rate of complete response, partial response and stable disease (clinical benefit rate)
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Safety and tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma
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