RecruitingPhase 1Phase 2NCT02343042

Selinexor and Backbone Treatments of Multiple Myeloma Patients

A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma


Sponsor

Karyopharm Therapeutics Inc

Enrollment

300 participants

Start Date

Oct 1, 2015

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing selinexor — a drug that blocks cancer cells from hiding from the immune system — in combination with other standard multiple myeloma (a blood cancer) treatments in patients whose cancer has returned or stopped responding to prior therapy. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of multiple myeloma - Your myeloma has come back or stopped responding to prior treatment - Your disease is measurable by blood or urine protein tests, or by bone marrow biopsy - Your general health and organ function meet the required levels - You have had at least one prior treatment regimen **You may NOT be eligible if...** - You have serious heart, liver, or kidney problems - You have active uncontrolled infection - You are pregnant or breastfeeding - You have a history of certain prior treatments that conflict with the study drugs - You have active brain involvement with myeloma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSelinexor

Oral tablets

DRUGDexamethasone

Oral tablets

DRUGLenalidomide

Oral capsule

DRUGPomalidomide

Oral tablets

DRUGBortezomib

Subcutaneous Injection (single use vial)

DRUGDaratumumab

Intravenous Infusion

DRUGCarfilzomib

Intravenous infusion

DRUGIxazomib

Oral capsule

DRUGElotuzumab

Intravenous infusion

DRUGClarithromycin

Tablets

DRUGBelantamab Mafodotin

Intravenous infusion

DRUGMezigdomide

Oral Capsules


Locations(25)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Jonnsson Comprehensive Cancer Center / University of Los Angeles

Los Angeles, California, United States

Sarah Cannon-Colorado Blood Cancer Institute

Denver, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States

Columbia University

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Wilmot Cancer Center/ University of Rochester

Rochester, New York, United States

University of North Carolina - Chapel Hill Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Duke Institute of Cancer/ Duke University

Durham, North Carolina, United States

Sarah Cannon- Tennessee Oncology Nashville

Nashville, Tennessee, United States

Fred Hutch Cancer Center

Seattle, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Tom Baker Cancer Center/Alberta Health Services

Calgary, Alberta, Canada

Cross Cancer Institute / University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Memorial Hospital of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Royal Victoria Hospital / McGill University

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02343042


Related Trials