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.
Drug: Plerixafor (AMD3100)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma|
- To evaluate the safety of plerixafor and bortezomib, to identify the maximum tolerated dose of plerixafor and bortezomib and to assess the response rate of plerixafor and bortezomib in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To assess time to progression. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To assess duration of response. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To assess mobilization of MM cells and other BM microenvironment cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To determine the degree of apoptosis in mobilized MM cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Plerixafor (AMD3100)and Bortezomib
Plerixafor (AMD3100)and Bortezomib
Drug: Plerixafor (AMD3100)
Given subcutaneously on days 1 through 6.
Other Name: AMD3100Drug: bortezomib
Given intravenously on days 3, 6, 10 and 13 (90 minutes after AMD3100)
Other Name: velcade
- 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.
|Contact: Irene Ghobrial, MDemail@example.com|
|Contact: Stacey Chuma, RNfirstname.lastname@example.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Kenneth H Shain, M.D., Ph.D. 813-745-6841 Ken.Shain@moffitt.org|
|Principal Investigator: Kenneth H Shain, M.D., Ph.D.|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Irene Ghobrial, MD|
|Cape Cod Hospital||Recruiting|
|Hyannis, Massachusetts, United States, 02601|
|Contact: Frank Basile, MD 508-862-7575 email@example.com|
|Principal Investigator: Frank Basile, MD|
|Milford, Massachusetts, United States, 01757|
|Contact: Michael Constantine, MD 508-488-3700 Michael_Constantine@dfci.harvard.edu|
|Principal Investigator: Michael Constantine, MD|
|Newton, Massachusetts, United States, 02462|
|Contact: Caroline Block, MD 617-658-6000 firstname.lastname@example.org|
|Principal Investigator: Caroline Block, MD|
|Principal Investigator:||Irene Ghobrial, MD||Dana-Farber Cancer Institute|