Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
NCT00036140
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
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.
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| 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 ICMJE | Phase 1 | ||
| Study Design ICMJE | Primary Purpose: Treatment | ||
| Condition ICMJE | Multiple Myeloma | ||
| Intervention ICMJE | Drug: Investigational drug | ||
| Study Arms ICMJE | 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 | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | 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:
Exclusion Criteria: Any of the following will exclude patients from study participation:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00036140 | ||
| Other Study ID Numbers ICMJE | 196-ONC-0100-006 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | March 2004 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||