Selinexor and Backbone Treatments of Multiple Myeloma Patients

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NCT02343042 · readout ≤ 253 d

Sponsored by Karyopharm Therapeutics Inc (industry) · KPTI — their whole pipeline →. With Bristol-Myers Squibb.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

300estimated

Sites

Countries

Canada, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

Oct 2015

actual

When the study began enrolling

Primary completion

Apr 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2027

estimated

The whole study's end, after follow-up

First posted

2015-01-21

estimated

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-15

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Multiple Myeloma

Interventions

Drug: Selinexor — also filed as KPT-330, XPOVIO®
Drug: Dexamethasone — also filed as Decadron®
Drug: Lenalidomide — also filed as Revlimid®
Drug: Pomalidomide — also filed as Pomalyst®
Drug: Bortezomib — also filed as Velcade®
Drug: Daratumumab — also filed as Darzalex®
Drug: Carfilzomib — also filed as Kyprolis®
Drug: Ixazomib — also filed as Ninlaro®
Drug: Elotuzumab — also filed as Empliciti®
Drug: Clarithromycin — also filed as Biaxin
Drug: Belantamab Mafodotin — also filed as BLENREP
Drug: Mezigdomide — also filed as BMS-986348, CC-92480

Primary outcomes

what the primary-completion date above is the date OF

Phase 1 (Dose-escalation): Maximum Tolerated Dose (MTD)

measured 12 months

Phase 1 (Dose-escalation): Recommended Phase-2 dose (RP2D)

measured 12 months

Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor

measured Pre-dose, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)

Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor

measured Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)

Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf)

measured Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)

Phase 2 (Expansion): Overall response rate (ORR)

measured 12 months

Phase 2 (Expansion): Duration of response (DOR)

measured 12 months

Phase 2 (Expansion): Clinical Benefit Rate (CBR)

measured 12 months

Publications

PMID 38826786 — linked by the registry
PMID 37393120 — linked by the registry
PMID 30352784 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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