Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
- 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
- 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Irene Ghobrial, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Cape Cod Hospital||Hyannis, Massachusetts 02601|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Newton-Wellesley Hospital||Newton, Massachusetts 02462|
|Moffitt Cancer Center||Tampa, Florida 33612|
|Milford Hospital||Milford, Massachusetts 01757|