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OpenTrials
Completed

NCT Number: NCT00096837

A Study of Motexafin Gadolinium for the Treatment of 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motexafin Gadolinium Injection

Drug

Primary outcomes

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

Secondary outcomes

  1. Progression-free survival

  2. Safety and tolerability

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study title

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

Important dates

First posted
Nov 17, 2004
Registry last updated
Jun 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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