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Study of DOXIL/CAELYX and VELCADE or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 and over
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Pharmaceutical / Industry
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DOXIL MMY 3001 NCT00103506
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Trial Description
Summary This is a randomized, parallel-group, open-label, multicenter study in 18 countries. Approximately 630 subjects with multiple myeloma whose disease has progressed after an initial response to at least 1 line of prior therapy or was refractory to initial treatment will be enrolled. Eligibility Criteria Inclusion Criteria: - Male or female and at least 18 years-of-age
- Confirmed diagnosis of multiple myeloma with evaluable disease parameters
- Progression of disease after an initial response (complete, partial, or minimal) to at least 1 line of therapy
- Life expectancy of at least 3 months
- At randomization specific hematologic and biochemical values
- Acceptable cardiovascular function
- Recovered from the acute toxicity of any prior treatment
- Female subjects, or the female partners of male subjects, practicing an effective method of birth control
- Negative serum or urine b-hCG pregnancy test at screening for subjects of child-bearing potential
- Able to respond to health outcomes questionnaire
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria: - History of treatment with VELCADE
- Progressive disease while receiving an anthracycline-containing regimen
- No change (NC) in disease status during initial therapy
- Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 240 mg/m2
- Myocardial infarct within 6 months before enrollment
- Treatment with nitrosoureas within 42 days before randomization
- Treatment with chemotherapy (other than nitrosoureas), clarithromycin, or immunotherapy (e.g.—interferon) within 21 days before randomization
- Treatment with antibody therapy within 60 days before randomization
- Treatment with plasmapheresis within 30 days before randomization
- Major surgery within 30 days before randomization
- Radiation therapy within 30 days before randomization
- Allergic reactions to compounds containing boron, mannitol or doxorubicin, or other components of DOXIL/CAELYX or VELCADE
- Treatment for a malignant condition, other than multiple myeloma, within the 5 years prior to enrollment; except for basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or cervical cancer in situ within the past 5 years
- Known to be seropositive for HIV, or active hepatitis A, B, or C infection
- Poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study
- Pregnant or breast-feeding
- Use of an investigational drug or medical device within 30 days before randomization
Trial Contact Information
Trial Lead Organizations/Sponsors Johnson & Johnson Pharmaceutical Research & Development, LLC Johnson & Johnson Pharmaceutical Research & Development, L.L.C | | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00103506 Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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