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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: Recruiting Phase 1 study of Multiple Myeloma, sponsored by Karyopharm Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
MTD for once weekly and twice weekly selinexor dose cohorts in the 11 Arms will be evaluated.
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2015-10 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
What NCT02343042 shows while recruiting
NCT02343042 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (45% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02343042's enrollment target sits among peer trials
300 75th of 438 higher than 361 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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