Dose Finding Pilot Study of Cabozantinib (XL184) Administered Orally as Monotherapy for the Treatment of Patients With Relapsed or Relapsed/Refractory Multiple Myeloma With Bone Disease
Since we are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants that have multiple myeloma, not
everyone who participates in this research study will receive the same dose of study drug.
The dose you get will depend on the number of participants who have been enrolled in the
study before you and how well they have tolerated their doses.
The study drug, cabozantinib, comes in the form of tablets which you will take by mouth. You
will take your dose of cabozantinib once a day during each 28 day cycle.
Detailed instructions on how to take the study drug and which foods and drinks you will be
prohibited from taking during the research study can be found in your study drug diary.
During Cycle 1, you will come into the clinic weekly (Day 1, 8, 15 and 22). For all other
cycles, you will come into the clinic on Day 1 and 15.
A visit will be scheduled 30 days after you have finished or stopped taking the study drug
so your doctor will be able to check your well being.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of Cabozantinib
To determine the safety of cabozantinib in patients with multiple myeloma with bone disease
Andrew Yee, MD
Massachusetts General Hospital, Boston
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|