Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	OSU-0347 NCI-6186, OSU-2003C0090, 6186, NCT00079456

Objectives

Primary

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

Secondary

1. Determine the progression-free survival of patients treated with this drug.
2. Determine the toxicity of this drug in these patients.
3. Determine the presence of PTEN mutation in patients treated with this drug.
4. Correlate the pharmacokinetics of this drug with response in these patients.
5. Correlate the pharmacodynamic effects of this drug with response in these patients.

Entry Criteria

Disease Characteristics:

• 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

   [Note: *Patients who receive only radiotherapy or bisphosphonates are not eligible]




• No solitary plasmacytoma

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• See Chemotherapy
• More than 4 weeks since prior thalidomide and recovered

Chemotherapy

• See Disease Characteristics
• Prior high-dose chemotherapy and stem cell transplantation allowed
• More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

• See Disease Characteristics
• More than 4 weeks since prior high-dose corticosteroids and recovered

Radiotherapy

• See Disease Characteristics

Other

• 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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count > 1,200/mm³
• Platelet count > 75,000/mm³

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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 years
• No psychiatric illness or social situation that would preclude study compliance

Expected Enrollment

A total of 16-25 patients will be accrued for this study within 8-12.5 months.

Outcomes

Overall response rate

Progression-free survival
Toxicity
Incidence of PTEN mutation
Pharmacodynamics

Outline

This is an open-label study.

Patients receive CCI-779 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.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Michael Grever, MD, Protocol chair		Ph: 614-293-8724 Email: michael.grever@osumc.edu

Registry Information
Official Title		A Phase II Trial Of CCI-779 In Patients With Relapsed Or Refractory Multiple Myeloma
Trial Start Date		2004-02-18
Trial Completion Date		2009-03-17
Registered in ClinicalTrials.gov		NCT00079456
Date Submitted to PDQ		2004-02-06
Information Last Verified		2006-08-24
NCI Grant/Contract Number		CA16058, CA76576, CA112894

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