Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma - Full Text View

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

Genetics Home Reference related topics:

aceruloplasminemia hemophilia

MedlinePlus related topics:

Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

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

Keywords provided by Pfizer:

Pharmacia

Study placed in the following topic categories:

Immunoproliferative Disorders

Hemorrhagic Disorders

Multiple myeloma

Hematologic Diseases

Blood Protein Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Lymphoproliferative Disorders

Hemostatic Disorders

Neoplasms, Plasma Cell

Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008

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