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

NCT ID: NCT00036140

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Keywords

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Pharmacia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Investigational drug

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Locations

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Research Center

Los Angeles, California, United States

Site Status

Research Center

Los Angeles, California, United States

Site Status

Research Center

Rancho Mirage, California, United States

Site Status

Research Center

Cleveland, Ohio, United States

Site Status

Research Center

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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196-ONC-0100-006

Identifier Type: -

Identifier Source: org_study_id