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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Investigational drug
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Pharmacia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Center
  • Research Center
  • Research Center
  • Research Center
  • Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00036140
Brief Title
Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Pharmacia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Investigational drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Research Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Research Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

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

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