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NCT00036140 Clinical Trial

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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036140
Other study ID # 196-ONC-0100-006
Secondary ID
Status Completed
Phase Phase 1
First received May 8, 2002
Last updated June 23, 2005

Study information
Verified date March 2004
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Investigational drug

Locations
Country Name City State
United States Research Center Cleveland Ohio
United States Research Center Los Angeles California
United States Research Center Los Angeles California
United States Research Center Marshfield Wisconsin
United States Research Center Rancho Mirage California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

See also
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