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Trial record 81 of 182 for:    carfilzomib OR pr-171

Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma (SCORE)

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ClinicalTrials.gov Identifier: NCT02628704
Recruitment Status : Withdrawn
First Posted : December 11, 2015
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief Summary:
Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Selinexor Drug: Placebo (for selinexor) Drug: carfilzomib Drug: Dexamethasone Phase 2

Detailed Description:

This is a Phase 2, two-arm, randomized, placebo-controlled, double-blind, multicenter study of relapsed/refractory multiple myeloma patients who have received at least two prior therapies, including a proteasome inhibitor and an IMiD.

Patients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms:

  • selinexor + carfilzomib + dexamethasone
  • placebo + carfilzomib + dexamethasone

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Selinexor (KPT-330), Carfilzomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma Previously Treated With a Proteasome Inhibitor and an Immunomodulatory Drug
Study Start Date : December 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: Selinexor, carfilzomib and dexamethasone
60 mg of selinexor and and 20 mg of dexamethasone will be taken twice weekly. On days coinciding with carfilzomib administration, selinexor will be given between 30 minutes and 4 hours after the end of the carfilzomib infusion.
Drug: Selinexor
The fixed dose of selinexor is 60 mg (three 20 mg tablets)
Other Name: KCP-330

Drug: carfilzomib
Administered as an IV infusion on Days 1, 2, 8, 9, 15 and 16 of each 4-week cycle for Cycles 1-13 and then on Days 1, 2, 15, and 16 for Cycles ≥ 14.
Other Name: Kyprolis

Drug: Dexamethasone
Fixed oral dose of 20 mg will be given twice weekly (Days 1, 2, 8, 9, 15, 16, 22 and 23) in each cycle.

Placebo Comparator: Placebo, carfilzomib and dexamethasone
Placebo (for 60 mg of selinexor) and and 20 mg of dexamethasone will be taken twice weekly. On days coinciding with carfilzomib administration, Placebo (for 60 mg of selinexor) will be given between 30 minutes and 4 hours after the end of the carfilzomib infusion.
Drug: Placebo (for selinexor)
sugar tablet manufactured to mimic selinexor tablet

Drug: carfilzomib
Administered as an IV infusion on Days 1, 2, 8, 9, 15 and 16 of each 4-week cycle for Cycles 1-13 and then on Days 1, 2, 15, and 16 for Cycles ≥ 14.
Other Name: Kyprolis

Drug: Dexamethasone
Fixed oral dose of 20 mg will be given twice weekly (Days 1, 2, 8, 9, 15, 16, 22 and 23) in each cycle.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Assessed from the date of first dose of blinded study treatment until the date that PD assessed up to 24 months ]


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:

  • Symptomatic, histologically confirmed MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:

    • Serum M-protein ≥ 1.0 g/dL by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative IgA; or
    • Urinary M-protein excretion at least 200 mg/24 hours; or
    • Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal.
    • If serum protein electrophoresis is felt to be unreliable for routine M- protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable.
  • Must have received ≥ 2 prior anti-MM therapies including a proteasome inhibitor and an IMiD. The most recent proteasome inhibitor must not have been carfilzomib.
  • Patients previously treated with carfilzomib are eligible as long as they meet the following criteria:

    • Not received carfilzomib within 6 months (183 days) of Cycle 1 Day 1 (C1D1), and
    • Carfilzomib was not part of their most recent therapy for the treatment of MM, and
    • Did not discontinue carfilzomib treatment because of adverse effects.
  • MM that is refractory to the most recent treatment regimen. Refractory is defined as ≤ 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy.

Exclusion Criteria:

  • Smoldering MM.
  • Active plasma cell leukemia.
  • MM that does not express M-protein or serum FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or serum FLC are excluded).
  • Documented active systemic amyloid light chain amyloidosis.
  • Active MM involving the central nervous system.
  • Active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
  • Prior autologous stem cell transplantation < 1 month or allogenic stem cell transplantation < 3 months prior to C1D1.
  • Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.

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): NCT02628704


Locations
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United States, California
James R. Berenson MD, Inc
West Hollywood, California, United States, 90069
United States, North Carolina
Waverly Hematology
Cary, North Carolina, United States, 27518
Sponsors and Collaborators
Karyopharm Therapeutics Inc

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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02628704     History of Changes
Other Study ID Numbers: KCP-330-015
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Karyopharm Therapeutics Inc:
Karyopharm
selinexor
KPT-330
multiple myeloma
SCORE
Additional relevant MeSH terms:
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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
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors