Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03756896|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : December 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Drug: Carfilzomib Drug: Dexamethasone Drug: Pomalidomide||Phase 2|
I. To determine the ≥ complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Therapy With Carfilzomib, Pomalidomide and Dexamethasone (CPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In|
|Actual Study Start Date :||January 25, 2019|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
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.
- ≥ Complete response (CR) rates [ Time Frame: Up to 2 years after study start ]Completed response (CR) rates will be determined for CPd maintenance.
- Progression-free survival (PFS) [ Time Frame: From first dose until documented progression or death, assessed at 18 months ]Progression-free survival (PFS) is defined as the time from first dose until documented progression or death. A subject who neither progresses nor dies will be censored on the date of his or her last tumor assessments. PFS will be determined by using all enrolled patients in accordance with the intention to treat (ITT) principle.
- Best response on-study [ Time Frame: Up to 2 years after study start ]Best response on-study refers to the best response (very good partial response rate [VGPR], stringent complete response [sCR] rate) prior to discontinuation of all study therapy.
- Objective response rate (ORR) defined as the proportion of treated subjects who achieve a best response of CR, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR) [ Time Frame: Up to 2 years after study start ]The objective response rate (ORR) will be assessed using International Myeloma Working Group (IMWG) criteria.
- Duration of response (DOR) [ Time Frame: From first response (PR or better) until a progression event (documented progression or death), assessed up to 2 years ]Duration of response (DOR) is the time from first response (PR or better) until a progression event (documented progression or death). Only subjects who ever achieved a response of PR or better will be considered. Subjects who neither progress nor die will be censored on the date of their last tumor assessment.
- Overall survival (OS) [ Time Frame: Up to 2 years after study start ]Overall survival (OS) is defined as the time from first dose until documented death.
- Minimal residual disease (MRD) detection [ Time Frame: Up to 2 years after study start ]The achievement of minimal residual disease (MRD) will be evaluated and reported on patients that achieve a complete response. MRD testing will be performed by adaptive clonoSEQ testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756896
|Contact: Ajay Nooka, MD, MPHemail@example.com|
|Principal Investigator:||Ajay Nooka, MD, MPH||Emory University|