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

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00096837
• Lead Sponsor: Pharmacyclics LLC.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-11-16
• Study First Submitted QC: 2004-11-16
• Study First Posted: 2004-11-17
• Status Verified: 2006-06
• Last Update Submitted: 2006-06-07
• Last Update Posted: 2006-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of complete response, partial response and stable disease (clinical benefit rate)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Safety and tolerability

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States