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A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma


I. Determine the overall response rate in patients with relapsed or refractory multiple
myeloma treated with CCI-779.


I. Determine the progression-free survival of patients treated with this drug. II. Determine
the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in
patients treated with this drug.

IV. Correlate the pharmacokinetics of this drug with response in these patients.

V. Correlate the pharmacodynamic effects of this drug with response in these patients.

OUTLINE: This is an open-label study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- Diagnosis of multiple myeloma (MM)

- Salmon-Durie stage IIA or IIIA OR progressive stage IA disease

- Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria

- The following are considered major criteria:

- Plasmacytoma on tissue biopsy

- Bone marrow plasmacytosis with >= 30% plasma cells

- Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5
g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the
presence of Bence-Jones protein of >= 1 g/24 hour-urine collection

- The following are considered minor criteria:

- Bone marrow plasmacytosis 10-29%

- Monoclonal globulin spike present, but less than the levels defined for a
major criterion

- Lytic bone lesion

- Decrease in normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

- No non-secretory MM (absent serum or urinary M-protein)

- Failed at least 1 prior systemic therapy* (e.g., chemotherapy, high-dose
corticosteroids, thalidomide, or bortezomib) for the treatment of MM

- No solitary plasmacytoma

- Performance status - ECOG 0-2

- More than 6 months

- Absolute neutrophil count > 1,200/mm^3

- Platelet count > 75,000/mm^3

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Bilirubin =< 1.5 times ULN

- Creatinine =< 1.5 times ULN

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Fasting cholesterol =< 350 mg/dL

- Triglycerides =< 400 mg/dL

- No other concurrent uncontrolled illness

- No active or ongoing infection requiring oral or IV antibiotics

- No prior allergic reaction to compounds of similar chemical or biological composition
to CCI-779

- No other prior or concurrent malignancy or myelodysplasia except for the following:

- Basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Localized cancer treated with surgery only with no evidence of disease for > 5

- No psychiatric illness or social situation that would preclude study compliance

- More than 4 weeks since prior thalidomide and recovered

- Prior high-dose chemotherapy and stem cell transplantation allowed

- More than 4 weeks since prior chemotherapy and recovered

- More than 4 weeks since prior high-dose corticosteroids and recovered

- More than 4 weeks since prior bortezomib and recovered

- More than 4 weeks since other prior anti-myeloma systemic therapy and recovered

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:


Study Design:

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

Outcome Measure:

Proportion of patients with objective overall response rate (PR+CR)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Michael Grever

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Ohio State University Medical Center Columbus, Ohio  43210