Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03756896 |
Recruitment Status :
Active, not recruiting
First Posted : November 28, 2018
Last Update Posted : March 8, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | November 27, 2018 | ||||
First Posted Date ICMJE | November 28, 2018 | ||||
Last Update Posted Date | March 8, 2024 | ||||
Actual Study Start Date ICMJE | January 25, 2019 | ||||
Estimated Primary Completion Date | March 31, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
≥ Complete response (CR) rates [ Time Frame: Up to 2 years after study start ] Completed response (CR) rates will be determined for CPd maintenance.
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Original Primary Outcome Measures ICMJE |
≥ Complete response (CR) rates [ Time Frame: Up to 2 years after study start ] Completed response (CR) rates will be determined for CPD consolidation and maintenance.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma | ||||
Official Title ICMJE | Maintenance Therapy With Carfilzomib, Pomalidomide and Dexamethasone (CPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In | ||||
Brief Summary | This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma. | ||||
Detailed Description | PRIMARY OBJECTIVE: I. To determine the ≥ complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance. SECONDARY OBJECTIVES: I. To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients. II. To determine the best response rates (very good partial response rate [VGPR], stringent complete response [sCR] rate) with CPd maintenance. II. To evaluate the safety of the CPd combination as maintenance regimen. III. To characterize safety in subjects who receive CPd maintenance. IV. To evaluate the duration of response (DOR). V. To evaluate the overall survival (OS) in high-risk patients. VI. To evaluate the minimal residual disease (MRD) detection with CPd maintenance. OUTLINE: Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Plasma Cell Myeloma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Carfilzomib, pomalidomide, dexamethasone
Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
29 | ||||
Original Estimated Enrollment ICMJE |
34 | ||||
Estimated Study Completion Date ICMJE | March 31, 2026 | ||||
Estimated Primary Completion Date | March 31, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03756896 | ||||
Other Study ID Numbers ICMJE | IRB00097882 NCI-2017-02052 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) Winship4101-17 ( Other Identifier: Emory University Hospital/Winship Cancer Institute ) P30CA138292 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Ajay Nooka, Emory University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Emory University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Emory University | ||||
Verification Date | March 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |