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

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. Identifier: NCT00036140
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : June 24, 2005
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Investigational drug Phase 1

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036140

United States, California
Research Center
Los Angeles, California, United States, 90033
Research Center
Los Angeles, California, United States, 90048
Research Center
Rancho Mirage, California, United States, 92270
United States, Ohio
Research Center
Cleveland, Ohio, United States, 44106
United States, Wisconsin
Research Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Pfizer Identifier: NCT00036140     History of Changes
Other Study ID Numbers: 196-ONC-0100-006
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2004

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases