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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Investigational drug
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036140

Locations
United States, California
Research Center
Los Angeles, California, United States, 90048
Research Center
Los Angeles, California, United States, 90033
Research Center
Rancho Mirage, California, United States, 92270
United States, Ohio
Research Center
Cleveland, Ohio, United States, 44106
United States, Wisconsin
Research Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00036140     History of Changes
Other Study ID Numbers: 196-ONC-0100-006
Study First Received: May 8, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014