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

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NCT00036140

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Study Location
Research Center
Los Angeles, California, 90033, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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