A Study to Test the Combination of Selinexor (KPT-330), Ixazomib, and Dexamethasone in Patients With Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02831686|
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Relapsed and/or Refractory Multiple Myeloma||Drug: Selinexor Drug: Ixazomib Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigator-Initiated Phase I Study of Selinexor (KPT-330), Ixazomib, and Low Dose Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Selinexor (KPT-330), Ixazomib, and Dexamethasone
Patients with relapsed and/or refractory MM will be treated with ixazomib, selinexor, and dexamethasone, all of which will be administered orally.Ixazomib will be given on Days 1, 8, and 15 on a 28 day cycle.
Selinexor will be given twice weekly for three weeks, then there will be 1 week off (Days 1,3, 8,10, 15, 17) This study will follow a 3-by-3 dose escalation design.
Dexamethasone will be given on all days of Selinexor but will also be given on the week off from Selinexor (Days 1, 3, 8, 10,15, 17, 22, 24).
Other Name: (KPT-330)
- maximum tolerated dose (MTD) [ Time Frame: 1 year ]This study will follow a 3-by-3 dose escalation design.
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): NCT02831686
|United States, New Jersey|
|Memoral Sloan Kettering Basking Ridge|
|Basking Ridge, New Jersey, United States|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Nassau|
|Uniondale, New York, United States, 11553|
|Principal Investigator:||Ola Landgren, MD, PhD||Memorial Sloan Kettering Cancer Center|