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

This study has been completed.

First Received: May 8, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00036140

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: Investigational drug	Phase I

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036140

Locations

United States, California
Research Center
Los Angeles, California, United States, 90048
Research Center
Los Angeles, California, United States, 90033
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

More Information

No publications provided

Study ID Numbers:	196-ONC-0100-006
Study First Received:	May 8, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00036140 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacia

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 09, 2009