Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

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All Conditions

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Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

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Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

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Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Immunomodulating Agents

Dexamethasone acetate

Proteasome Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

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.

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.

The fixed dose of selinexor is 60 mg (three 20 mg tablets)

Selinexor

sugar tablet manufactured to mimic selinexor tablet

Placebo (for selinexor)

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.

carfilzomib

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

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.

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

Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma

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

Karyopharm Therapeutics Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma	NCT02628704	Multiple Myelom...	Selinexor Placebo (for se... carfilzomib Dexamethasone	18 Years -	Karyopharm Therapeutics Inc
Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma	NCT02628704	Multiple Myelom...	Selinexor Placebo (for se... carfilzomib Dexamethasone	18 Years -	Karyopharm Therapeutics Inc

Spots Global Cancer Trial Database for placebo (for selinexor)