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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00036140

First received: May 8, 2002

Last updated: June 23, 2005

Last verified: March 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: Investigational drug
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00036140
Other Study ID Numbers ^ICMJE	196-ONC-0100-006
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pfizer
Verification Date	March 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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