- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036140
Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
June 23, 2005 updated by: Pfizer
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.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Research Center
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Los Angeles, California, United States, 90033
- Research Center
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Rancho Mirage, California, United States, 92270
- Research Center
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Ohio
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Cleveland, Ohio, United States, 44106
- Research Center
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
May 8, 2002
First Submitted That Met QC Criteria
May 8, 2002
First Posted (Estimate)
May 9, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 2004
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 196-ONC-0100-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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GlaxoSmithKlineCompleted
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Avelas Biosciences, Inc.Clinipace Worldwide; RRD International, Inc.CompletedStage I Breast Cancer | Stage II Breast Cancer | Carcinoma, Ductal, Breast | Breast Cancer Female | Stage III Breast Cancer | Carcinoma Breast | Primary Invasive Malignant Neoplasm of Female BreastUnited States
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GlaxoSmithKlineCompleted
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NovartisCompleted
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AmgenCompletedSystemic Lupus ErythematosusUnited States
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Cancer Intelligence Care Systems, Inc.Stella Pharma CorporationCompletedAngiosarcoma | Malignant MelanomaJapan