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

NCT02628704 | Withdrawn Phase 2 DMC

• 1 other identifier: KCP-330-015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Keywords

Karyopharm; selinexor; KPT-330; multiple myeloma; SCORE

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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 Outcomes (1)

• Overall Response Rate (ORR)

  Assessed from the date of first dose of blinded study treatment until the date that PD assessed up to 24 months

Study Arms (2)

Selinexor, carfilzomib and dexamethasone

EXPERIMENTAL

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; Drug: carfilzomib; Drug: Dexamethasone

Placebo, carfilzomib and dexamethasone

PLACEBO COMPARATOR

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); Drug: carfilzomib; Drug: Dexamethasone

Interventions

Selinexor DRUG

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

Also known as: KCP-330

Selinexor, carfilzomib and dexamethasone

Placebo (for selinexor) DRUG

sugar tablet manufactured to mimic selinexor tablet

Placebo, carfilzomib and dexamethasone

carfilzomib DRUG

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.

Also known as: Kyprolis

Placebo, carfilzomib and dexamethasone; Selinexor, carfilzomib and dexamethasone

Dexamethasone DRUG

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, carfilzomib and dexamethasone; Selinexor, carfilzomib and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karyopharm Therapeutics Inc: lead

Study Sites (2)

James R. Berenson MD, Inc

West Hollywood, California, 90069, United States

Location

Waverly Hematology

Cary, North Carolina, 27518, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

selinexor; carfilzomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)