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Selinexor Treatment of Refractory Myeloma (STORM)

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: NCT02336815
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE January 8, 2015
First Posted Date  ICMJE January 13, 2015
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date July 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2015)
Overall Response Rate [ Time Frame: 5-7 months ]
Achievement of sCR, CR, VGPR, or PR for the overall evaluable population with supportive data provided by DOR (duration of response).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2015)
  • Duration of Response [ Time Frame: 5-7 months ]
    The duration of time measured from when measurement criteria for response were first met until the date of first recurrence, PD or death)
  • Clinical Benefit Rate [ Time Frame: 6 months ]
    Clinical Benefit Rate (CBR = sCR + CR + PR + Minor Response [MR]), and duration of CBR
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 Selinexor Treatment of Refractory Myeloma
Official Title  ICMJE A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab
Brief Summary This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).
Detailed Description

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd), both dosed twice weekly in each four-week cycle, in patients with MM previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and daratumumab.

This study consists of two parts:

  • Part 1 enrolled patients with both quad-refractory MM and penta-refractory MM.
  • Part 2 will enroll patients with penta-refractory MM only.
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
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Selinexor
    Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.)
    Other Name: KPT-330
  • Drug: Dexamethasone
    20 mg will be given with each dose of Selinexor.
Study Arms  ICMJE Experimental: Selinexor & Dexamethasone
Selinexor 80 mg (45 mg/m2 BSA) plus low-dose Dexamethasone (20 mg), both twice weekly by mouth
Interventions:
  • Drug: Selinexor
  • Drug: Dexamethasone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2018)
202
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2015)
80
Actual Study Completion Date  ICMJE July 26, 2019
Actual Primary Completion Date July 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:

  1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA
  2. Urinary M-protein excretion ≥ 200 mg/24 hours
  3. Free Light Chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal
  4. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative Ig levels by nephelometry or turbidimetry are acceptable

    • Must have previously received ≥ 3 anti-MM regimens including: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a glucocorticoid. There is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met.
    • MM refractory to previous treatment with one or more glucocorticoids, parenteral PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or pomalidomide), and the anti-CD38 mAb, daratumumab. Refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy.

Exclusion Criteria:

  • Active smoldering MM.
  • Active plasma cell leukemia.
  • Documented systemic amyloid light chain amyloidosis.
  • Active CNS MM.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 Austria,   Belgium,   France,   Germany,   Greece,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02336815
Other Study ID Numbers  ICMJE KCP-330-012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Karyopharm Therapeutics Inc
Study Sponsor  ICMJE Karyopharm Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc
PRS Account Karyopharm Therapeutics Inc
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP