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RECRUITING Phase 1

Selinexor and Backbone Treatments of Multiple Myeloma Patients

NCT02343042 · View on ClinicalTrials.gov ↗

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

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

36 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02343042 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Massachusetts, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02343042?

The interventions under investigation include: Selinexor (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Pomalidomide (DRUG), Bortezomib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02343042?

This trial is sponsored by Karyopharm Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial