Phase
Condition
Cancer/tumors
Multiple Myeloma
Red Blood Cell Disorders
Treatment
N/AClinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with symptomatic active multiple myeloma who have completed autotransplantare eligible for the study; patients should be assessed for eligibility within 35 daysof the transplant and treatment should commence within 10 weeks of the transplant
Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patientswith a poor performance status (3-4) are also eligible, if complications of the bonesuch as compression fracture, hyperviscosity or infection such as pneumonia have beenadequately treated
No significant co-morbid medical conditions; no uncontrolled life threateninginfection
Unsupported platelet count > 80,000/uL
Absolute neutrophil count (ANC) > 1000/uL
Signed informed consent should be obtained from all patients in accordance withinstitutional and federal guidelines
Exclusion
Exclusion Criteria:
Patients with a history of recent (< 6 months) myocardial infarction, unstable angina,difficult to control congestive heart failure, uncontrolled hypertension, difficult tocontrol significant cardiac arrhythmias, or arrhythmia associated with prolonged QTinterval
Pregnant or nursing women; women of child-bearing potential must have a negativepregnancy documented within one week of registration; women/men of reproductivepotential may not participate unless they have agreed to use two forms of effectivecontraceptive method
Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib,thalidomide, or other agents
Human immunodeficiency virus (HIV) positive patients
Transaminases > 2 x normal values
Bilirubin > 2 x normal values
Active uncontrolled infection
History of significant psychiatric illness; steroid induced psychosis
Study Design
Study Description
Connect with a study center
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available

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