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Selinexor Treatment of Refractory Myeloma (STORM)

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ClinicalTrials.gov Identifier: NCT02336815
Recruitment Status : Active, not recruiting
First Posted : January 13, 2015
Last Update Posted : May 16, 2018
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
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
Study Start Date : May 2015
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : October 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02336815


  Show 55 Study Locations
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc

Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02336815     History of Changes
Other Study ID Numbers: KCP-330-012
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Karyopharm Therapeutics Inc:
Multiple myeloma
Karyopharm
KPT-330
Selinexor
Refractory
Bortezomib
Carfilzomib
Lenalidomide
Pomalidomide
Dexamethasone
STORM
Daratumumab

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Lenalidomide
Pomalidomide
Daratumumab
Bortezomib
BB 1101
Proteasome Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones