Selinexor, Carfilzomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (SINE)
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|ClinicalTrials.gov Identifier: NCT02199665|
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma||Drug: selinexor Drug: carfilzomib Drug: dexamethasone||Phase 1|
I. Determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of the combination of selinexor, carfilzomib, and dexamethasone in relapsed and relapsed/refractory multiple myeloma.
I. Determine safety and tolerability.
II. Determine the efficacy, as measured by the rates of stable disease or better (including minimal response, partial response, very good partial response, complete response, and stringent complete response).
OUTLINE: This is a dose-escalation study of selinexor and carfilzomib.
Patients receive selinexor orally (PO), carfilzomib intravenously (IV), and dexamethasone PO QD or IV. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Combination of a Selective Inhibitor of Nuclear Export (SINE), Selinexor With Carfilzomib and Dexamethasone in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||June 12, 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Selinexor, carfilzomib, dexamethasone
Patients receive selinexor PO, carfilzomib IV, and dexamethasone PO QD or IV. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given PO or IV
- Maximum Tolerated Dose (MTD) of selinexor, carfilzomib, and dexamethasone [ Time Frame: 28 days ]Defined as the dose level below the dose in which greater than or equal to 2 out of 6 patients experience dose limiting toxicity. Will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Incidence of toxicities related to the combination of selinexor and carfilzomib assessed using NCI CTCAE version 4.0 [ Time Frame: Up to 28 days after completion of study treatment ]
- Efficacy as measured by stable disease or better (including MR, partial response, very good partial response, complete response and stringent complete response) according to IMWG criteria [ Time Frame: Up to 2 years ]The number of patients with stable disease or better will be summarized by dose level; 90% confidence intervals will be generated for the RP2D cohort.
- Incidence of toxicities assessed using NCI CTCAE version 4.0 [ Time Frame: Up to 28 days after completion of study treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199665
|United States, Arizona|
|Mayo Clinic (AZ)||Active, not recruiting|
|Scottsdale, Arizona, United States, 85259|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Andrzej J. Jakubowiak 773-702-1345 email@example.com|
|Principal Investigator: Andrzej J. Jakubowiak|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Active, not recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Wayne State University Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Michael Marano firstname.lastname@example.org|
|Contact: Carol Muzyk 313 576 9690 email@example.com|
|United States, New York|
|Mount Sinai Medical Center||Recruiting|
|New York, New York, United States, 10029|
|Contact: Ajai Chari, MD firstname.lastname@example.org|
|Principal Investigator:||Andrzej Jakubowiak||University of Chicago|