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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

58

Study ID:

NCT00903968

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

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There are 5 Locations for this study

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Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Cape Cod Hospital
Hyannis Massachusetts, 02601, United States
Milford Hospital
Milford Massachusetts, 01757, United States
Newton-Wellesley Hospital
Newton Massachusetts, 02462, United States
Cancer Treatment Centers of America (Eastern Regional Medical Center)
Philadelphia Pennsylvania, 19124, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

58

Study ID:

NCT00903968

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

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