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.
- Since we are looking for the highest doses of the combined study drugs that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma not everyone who participates will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been in the study before them and if they have tolerated their doses.
- Plerixafor will be given as an injection under the skin on days 1, 2, 4 and 5. Participants will receive plerixafor and bortezomib on days 3 and 6 and bortezomib alone on days 10 and 13. Bortezomib is administered intravenously. Each treatment cycle will last 21 days.
- The cycles will be repeated for up to 8 cycles as long as the participant does not have any severe or unmanageable side effects as the disease is responding to the study drug.
- While receiving study drugs and before the start of each study cycle, participants will come to the clinic and the following will be performed: physical exam, questions about current health and current medications, blood work, urine sample, x-rays (if deemed necessary) and EKG.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Plerixafor (AMD3100), bortezomib
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00903968
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Leukemia, Plasma Cell
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Bence Jones Protein
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.
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