Selinexor and Backbone Treatments of Multiple Myeloma Patients

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

• Multiple Myeloma

Interventions

DRUG

Selinexor

Oral tablets

DRUG

Dexamethasone

Oral tablets

DRUG

Lenalidomide

Oral capsule

DRUG

Pomalidomide

Oral tablets

DRUG

Bortezomib

Subcutaneous Injection (single use vial)

DRUG

Daratumumab

Intravenous Infusion

DRUG

Carfilzomib

Intravenous infusion

DRUG

Ixazomib

Oral capsule

DRUG

Elotuzumab

Intravenous infusion

DRUG

Clarithromycin

Tablets

DRUG

Belantamab Mafodotin

Intravenous infusion

DRUG

Mezigdomide

Oral Capsules

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Karyopharm Therapeutics Inc

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2027-04-30

Completion

2027-04-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations