Selinexor Treatment for Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy.
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04519476|
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma||Drug: Selinexor Drug: Lenalidomide Drug: Methylprednisolone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A pilot study examining selinexor's ability to overcome resistance in multiple myeloma patients who are refractory to lenalidomide-containing therapy.|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Examining Selinexor's Ability to Overcome Resistance in Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy.|
|Estimated Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||January 5, 2023|
|Estimated Study Completion Date :||January 5, 2023|
All subjects enrolled will receive: 1) selinexor, PO, at 60 mg once weekly on days 1-28 of a 28-day cycle, 2) lenalidomide, PO, 10 mg daily on days 1-21 of 28-days cycle and 3) methylprednisolone at the same dose and schedule as the last lenalidomide-containing regimen if it contained steroids. If patient's qualifying lenalidomide-containing regimen contained different type of steroid (e.g. prednisone, dexamethasone, etc.) then patient on this study will receive methylprednisolone at the equivalent dose and schedule.
Selinexor (KPT-330) is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
Other Name: KPT-330
Other Name: Revlimid
Other Name: Medrol
- Overall Response [ Time Frame: 30 months ]Overall Response Rate ([ORR]=CR +VGPR+ PR)
- Clinical Benefit Rate [ Time Frame: 30 months ]Clinical Benefit Rate ([CBR]= CR+VGPR+PR+MR)
- Adverse Events Occurrences [ Time Frame: 30 months ]Occurrence of adverse events throughout the study, graded via CTCAE v.5.0
- Time to progression (TTP) [ Time Frame: 30 months ]defined as the time from the initiation of therapy to progressive disease
- Progression-free survival (PFS) [ Time Frame: 30 months ]defined as the time from initiation of therapy to progressive disease or death from any cause, whichever occurs first
- Time to first response [ Time Frame: 30 months ]defined as the time from the initiation of therapy to the first evidence of confirmed clinical benefit defined as > minimal response (MR, including patients who achieved a complete response (CR), very good partial response (VGPR), partial response (PR), or MR
- Duration of Response (DOR) [ Time Frame: 30 months ]defined as the time from the first response to progressive disease
- Overall survival (OS) [ Time Frame: 30 months ]defined as the time from initiation of therapy to death from any cause or last follow-up visit
- Measuring levels of multiple myeloma specific biomarkers such as M-Protein and BCMA [ Time Frame: 30 months; duration of each cycle in this study is 28 days ]Levels will be measure on Day 1 Cycle 1 (baseline), Day 8 Cycle 1, Day 15 Cycle 1, Day 22 Cycle 1, and on Day 22 of every cycle thereafter. Duration of each cycle in this study is 28 days.
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): NCT04519476
|Contact: Noemi Silagan, MD||(310)623-1204||NSilagan@oncotherapeutics.com|
|Contact: Tanya Spektor, PhD||(323)email@example.com|
|United States, California|
|James R Berenson, MD, Inc.|
|West Hollywood, California, United States, 90069|
|Contact: James Berenson, MD|
|Contact: Regina Swift, RN, BSN 310-623-1222 firstname.lastname@example.org|
|Principal Investigator:||James R Berenson, MD||Oncotherapeutics|