Multiple Myeloma Clinical Trial
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
Summary
The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
ECOG Performance Status 0, 1, or 2
Laboratory values as outlined in the protocol
Exclusion Criteria:
Uncontrolled infection
Cytotoxic chemotherapy < 3 weeks, or biologic or targeted novel therapy < 2 weeks, or corticosteroids < 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
Pregnant women
Nursing women
Men or women of child-bearing potential who are unwilling to employ adequate contraception
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
Known to be HIV positive
Radiation therapy < 2 weeks prior to registration
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There are 5 Locations for this study
Boston Massachusetts, 02115, United States
Hyannis Massachusetts, 02601, United States
Milford Massachusetts, 01757, United States
Newton Massachusetts, 02462, United States
Philadelphia Pennsylvania, 19124, United States
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