Phase I/II Trial of Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma
- Since we are looking for the highest dose of CCI-779 (Temsirolimus) given in
combination with bortezomib (Velcade) that can be given to people without causing the
most serious or unmanageable side effects, not everyone who participates in this study
will be receiving the same amount of either drug.
- During the study treatment, participants will be given some medications to decrease the
chance they they will have an allergic reaction to CCI-779 (Temsirolimus). After these
drugs are given, participants will be receive bortezomib (Velcade) by injection
followed by an injection of CCI-779 (Temsirolimus). These drugs wil be given once a
week for four weeks (on Days 1, 8, 15, and 22). On the fifth week (Day 29),
participants will be given only CCI-779 along with the drugs to decrease the chance of
an allergic reaction.
- The cycle will last 35 days and will occur twice before the doctor evaluates for
response. The cycles will be repeated for up to 8 cycles as long as the participant
does not have any severe or unmanageable side effects and the disease is responding to
- While receiving study treatment, participants will be seen at the clinic at the start
of each cycle for the following: complete physical examination, blood work, urine
collection, x-ray of bones (if study doctor deems necessary) and an electrocardiogram
(prior to treatment and at the end of treatment)
- A bone skeletal survey will be performed at the end of treatment to measure the size of
the participants tumors.
- After 8 cycles of treatment or if the participant has ended treatment, more tests will
be performed. A physical exam, blood work, urine collection, skeletal survey,
electrocardiogram, bone marrow biopsy and aspirate will be performed.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity. Number of Patients With Specific Toxicities Are Reported.
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
Irene Ghobrial, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Washington University in Saint Louis||St. Louis, Missouri|