Back to results

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

Primary Purpose

Multiple Myeloma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Selinexor

Placebo (for selinexor)

carfilzomib

Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Karyopharm, selinexor, KPT-330, multiple myeloma, SCORE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

James R. Berenson MD, Inc
Waverly Hematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Selinexor, carfilzomib and dexamethasone

Placebo, carfilzomib and dexamethasone

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Overall Response Rate (ORR)

Full Information

NCT ID

NCT02628704

First Posted

December 2, 2015

Last Updated

January 24, 2023

Sponsor

Karyopharm Therapeutics Inc

1. Study Identification

Unique Protocol Identification Number

NCT02628704

Brief Title

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

Acronym

SCORE

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 Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Withdrawn

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Karyopharm Therapeutics Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Selinexor, carfilzomib and dexamethasone

Arm Type

Experimental

Arm Description

Arm Title

Placebo, carfilzomib and dexamethasone

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Selinexor

Other Intervention Name(s)

KCP-330

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo (for selinexor)

Intervention Description

sugar tablet manufactured to mimic selinexor tablet

Intervention Type

Drug

Intervention Name(s)

carfilzomib

Other Intervention Name(s)

Kyprolis

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

James R. Berenson MD, Inc

City

West Hollywood

State/Province

California

ZIP/Postal Code

90069

Country

United States

Facility Name

Waverly Hematology

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs