NCT00096837

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2004

Completed
Last Updated

June 8, 2006

Status Verified

June 1, 2006

First QC Date

November 16, 2004

Last Update Submit

June 7, 2006

Conditions

Multiple Myeloma

Keywords

MyelomaMultiple MyelomaRelapsed Multiple MyelomaRefractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Progression-free survival

  • Safety and tolerability

Interventions

Motexafin Gadolinium InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2004

First Posted

November 17, 2004

Last Updated

June 8, 2006

Record last verified: 2006-06

Locations

US(1)