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NCT02343042 · ClinicalTrials.gov registry record · Phase 1

Selinexor and Backbone Treatments of Multiple Myeloma Patients

A Phase 1 study of Multiple Myeloma, sponsored by Karyopharm Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
300
Enrollment target
20
Study locations

NCT02343042 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by Karyopharm Therapeutics. The registered enrollment target is 300 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT02343042, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by Karyopharm Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

This study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: * Arm 1: Selinexor + dexamethasone + pomalidomide (SPd); enrollment complete * Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete * Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete * Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd); enrollment complete * Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete * Arm 6: Selinexor + dexamethasone + carfilzomib (SKd); enrollment complete * Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM; enrollment complete * Arm 8: Selinexor + dexamethasone + ixazomib (SNd); enrollment complete * Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd); enrollment complete * Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd); enrollment complete * Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd); enrollment complete * Arm 12: Selinexor + dexamethasone + mezigdomide (SMd); actively recruiting Selinexor pharmacokinetics: * PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 \[SPVd\], Arm 6 \[SKd\], Arm 8 \[SNd\], Arm 9 \[SPEd\], Arm 10 \[SBd\], and Arm 11 \[SDPd\]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor. This run-in period does not apply to Arm 12 (SMd).

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG Selinexor
  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Pomalidomide
  • DRUG Bortezomib

Study Locations (20)

New York

  • Columbia University - New York
  • Weill Cornell Medicine - New York
  • Wilmot Cancer Center/ University of Rochester - Rochester

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

North Carolina

  • University of North Carolina - Chapel Hill Comprehensive Cancer Center - Chapel Hill
  • Duke Institute of Cancer/ Duke University - Durham

Washington

  • Fred Hutch Cancer Center - Seattle
  • Swedish Cancer Institute - Seattle

Alberta

  • Tom Baker Cancer Center/Alberta Health Services - Calgary
  • Cross Cancer Institute / University of Alberta - Edmonton

Arizona

  • Banner MD Anderson Cancer Center - Gilbert

California

  • Jonnsson Comprehensive Cancer Center / University of Los Angeles - Los Angeles

Colorado

  • Sarah Cannon-Colorado Blood Cancer Institute - Denver

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2015-10
Est. Completion 2027-04
Phase Phase 1

Sponsor

Karyopharm Therapeutics

25 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02343042

The ClinicalTrials.gov registry entry for NCT02343042 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (45% lower). The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Selinexor is the first listed.

NCT02343042 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Massachusetts, North Carolina.

Frequently Asked Questions

What is clinical trial NCT02343042 about?

NCT02343042 is a clinical study titled "Selinexor and Backbone Treatments of Multiple Myeloma Patients". This study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be...

What is the current status of trial NCT02343042?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2015-10. Estimated completion is 2027-04.

What conditions does trial NCT02343042 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT02343042?

The interventions under investigation include: Selinexor (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Pomalidomide (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT02343042?

This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02343042 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.