- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047203
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol.
II. Determine the disease-free survival and overall survival of patients treated with this drug.
III. Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation status, and BCRP expression in patients treated with this drug.
IV. Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 1 year.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment
Durie-Salmon stage I or greater at diagnosis
- Patients with non-secretory or oligo-secretory MM (defined as maximum urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less than 0.5 g/dL during entire disease course) must have at least 30% bone marrow plasma cells
- Patients with secretory MM must have measurable disease defined as serum monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200 mg/24 hours
Must have received at least 1, but no more than 5 prior therapy regimens
- Patients who have had 4 or 5 regimens are allowed provided corticosteroids and/or thalidomide are part of the regimens
- No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone or thalidomide)
- Prior autologous peripheral blood stem cell transplantation is considered 1 prior regimen
- Performance status - ECOG 0-2
- Performance status - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture)
- Absolute neutrophil count at least 750/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST no greater than 2.5 times ULN
- Creatinine no greater than 3 mg/dL
- No myocardial infarction within the past 6 months
- Peripheral neuropathy secondary to prior drug therapy or myeloma-associated neuropathy allowed
- No other uncontrolled serious medical condition
- No uncontrolled infection
- No other active malignancy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- See Disease Characteristics
- No prior allogeneic stem cell transplantation
- At least 10 days since prior thalidomide
- No concurrent biologic therapy
- See Disease Characteristics
- At least 2 weeks since prior myelosuppressive chemotherapy
- No other concurrent chemotherapy
- See Disease Characteristics
No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)
- Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone no more than 40 mg/day
- At least 10 days since prior bortezomib or tipifarnib
- Concurrent bisphosphonates allowed if on stable dose before study entry
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 (flavopiridol)
Patients receive flavopiridol IV over 1 hour on days 1-3.
Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity.
|
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed response (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart.
Time Frame: First 3 months of treatment
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Ninety percent confidence intervals for the true success proportion will be calculated assuming a binomial distribution.
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First 3 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival time
Time Frame: Time from registration to death due to any cause, assessed up to 1 year
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The distribution of survival time will be estimated using the method of Kaplan-Meier.
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Time from registration to death due to any cause, assessed up to 1 year
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Time to disease progression
Time Frame: Time from registration to documentation of disease progression, assessed up to 1 year
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The distribution of time to progression will be estimated using the method of Kaplan-Meier.
|
Time from registration to documentation of disease progression, assessed up to 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Angela Dispenzieri, Mayo Clinic
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
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Alvocidib
Other Study ID Numbers
- NCI-2012-02496
- N01CM17104 (U.S. NIH Grant/Contract)
- MC018B
- CDR0000257567 (Registry Identifier: PDQ (Physician Data Query))
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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