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Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00036140
First Posted: May 9, 2002
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
May 8, 2002
May 9, 2002
June 24, 2005
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No Changes Posted
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Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
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The primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma.
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Interventional
Phase 1
Primary Purpose: Treatment
Multiple Myeloma
Drug: Investigational drug
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

  • Eligible patients must be at least 18 years of age with a diagnosis of multiple myeloma including elevated M-blood/urine protein or a tumor that can be evaluated by the doctor during the investigational drug's treatment.
  • The patient's multiple myeloma must have gotten worse during/after previous chemotherapy was given.
  • Any side-effects from prior chemotherapy must have subsided
  • Blood and urine tests must show adequate bone marrow, liver, and kidney function.

Exclusion Criteria:

Any of the following will exclude patients from study participation:

  • indolent or smoldering myeloma or localized plasmacytoma
  • hyperviscosity syndrome
  • irradiation to 25% or more of bone marrow
  • prior high dose chemotherapy with bone marrow or stem cell support
  • current participation in other clinical trials
  • pregnant or breast-feeding women
  • known HIV-positive or AIDS-related illness
  • patients planning to have radiation therapy or surgery that would interrupt study therapy in the next 6 months.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00036140
196-ONC-0100-006
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Pfizer
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Pfizer
March 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP