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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00096837
First received: November 16, 2004
Last updated: June 7, 2006
Last verified: June 2006
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096837

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Pharmacyclics
  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:
Myeloma
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

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

ClinicalTrials.gov processed this record on September 16, 2014