- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00079456
Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779.
SECONDARY OBJECTIVES:
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 years
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (temsirolimus)
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.
|
Correlative studies
Correlative studies
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with objective overall response rate (PR+CR)
Time Frame: Up to 5 years
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of toxicities
Time Frame: Up to 5 years
|
Up to 5 years
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Progression-free survival
Time Frame: Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years
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Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Grever, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- NCI-2012-01448 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- N01CM62207 (U.S. NIH Grant/Contract)
- 6186 (CTEP)
- NCI-6186
- OSU-0347
- CDR0000355767
- OSU-2003C0090
- 0347 (Ohio State University Medical Center)
- R21CA112894 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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