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

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Selinexor Drug: Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : July 26, 2019
Actual Study Completion Date : July 26, 2019

Arm Intervention/treatment
Experimental: Selinexor & Dexamethasone
Selinexor 80 mg (45 mg/m2 BSA) plus low-dose Dexamethasone (20 mg), both twice weekly by mouth
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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

  2. Clinical Benefit Rate [ Time Frame: 6 months ]
    Clinical Benefit Rate (CBR = sCR + CR + PR + Minor Response [MR]), and duration of CBR

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02336815

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Sponsors and Collaborators
Karyopharm Therapeutics Inc
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Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Karyopharm Therapeutics Inc Identifier: NCT02336815    
Other Study ID Numbers: KCP-330-012
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Karyopharm Therapeutics Inc:
Multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents