Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2017 |
| Start Date: | May 2009 |
| End Date: | October 2016 |
Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
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.
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.
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
We found this trial at
5
sites
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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Philadelphia, Pennsylvania 19124
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