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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 16, 2004
Last updated: June 7, 2006
Last verified: June 2006
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.

Condition Intervention Phase
Multiple Myeloma
Drug: Motexafin Gadolinium Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • Rate of complete response, partial response and stable disease (clinical benefit rate)

Secondary Outcome Measures:
  • Progression-free survival
  • Safety and tolerability

Estimated Enrollment: 25

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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


  • Not pregnant or lactating
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00096837

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00096837     History of Changes
Other Study ID Numbers: PCYC-0215
Study First Received: November 16, 2004
Last Updated: June 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Motexafin gadolinium
Antineoplastic Agents
Contrast Media
Dermatologic Agents
Diagnostic Uses of Chemicals
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on December 01, 2015