NCT Number: NCT00036140
Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Research Center, Los Angeles, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Pfizer
Industry
Registry information
Important dates
- First posted
- May 9, 2002
- Registry last updated
- Jun 24, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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