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Phase I/II Trial of Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma

Phase 1/Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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.

Inclusion Criteria:

- 18 years of age or older

- Must have received prior therapy for their myeloma and have relapsed and/or
relapsed/refractory multiple myeloma

- Monoclonal protein in the serum of greater than or equal to 1 gm/dL or monoclonal
light chain in the urine protein electrophoresis of greater than or equal to 200mg/24
hours, or measurable light chains by free light chain assay of greater than or equal
to 10mg/dl, or measurable plasmacytoma

- ECOG Performance Status 0, 1 or 2

- Laboratory values as outlined in the protocol

Exclusion Criteria:

- Uncontrolled infection

- Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or
corticosteroids less than 2 weeks prior to registration. Patients may be receiving
chronic corticosteroids if they are being given for disorders other than myeloma.

- Pregnant or nursing women

- Men or women of childbearing potential who are unwilling to employ adequate

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational within 14 days before enrollment

- Known to be HIV positive

- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV
hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
electrocardiographic evidence of acute ischemia or active conduction system

- Hypersensitivity to bortezomib, boron or mannitol

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical trial

- Patients who may need or are receiving live vaccines for immunization

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity. Number of Patients With Specific Toxicities Are Reported.

Outcome Description:

Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.

Outcome Time Frame:

10 months

Safety Issue:


Principal Investigator

Irene Ghobrial, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

February 2012

Related Keywords:

  • Multiple Myeloma
  • Temsirolimus
  • Bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of MichiganAnn Arbor, Michigan  48109-0624
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Washington University in Saint LouisSt. Louis, Missouri