RecruitingPhase 2NCT04414475

A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.

A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory Multiple Myeloma

Sponsor

Karyopharm Therapeutics Inc

Enrollment

127 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma, Refractory

Summary

The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called selinexor — alone or in combination with another drug called bortezomib — for people with multiple myeloma (a blood cancer) that has stopped responding to many prior treatments. **You may be eligible if...** - You are 18 or older - You have multiple myeloma with measurable disease - Your myeloma has come back or stopped responding to at least 3–4 prior treatment regimens, including specific drug classes (proteasome inhibitors, immunomodulatory drugs, and a CD38 antibody like daratumumab) - You can give written informed consent **You may NOT be eligible if...** - Your myeloma cannot be measured by standard lab tests - You have not tried the required prior therapies - You have severe organ problems that would prevent you from tolerating the treatment - You are pregnant 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.

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Interventions

DRUGSelinexor

Participants will receive Selinexor oral tablets.

DRUGDexamethasone

Participants will receive Dexamethasone oral tablets.

DRUGBortezomib

Participants will receive Bortezomib SC injection.

Locations(16)

University General Hospital of Patras

Pátrai, Achaia, Greece

General Hospital of Athens "Alexandra"

Attiki, Athens, Greece

General Hospital of Athens "Evangelismos"

Athens, Attica, Greece

Theageneion Cancer Hospital

Thessaloniki, Thessaloniki, Greece

Emek Medical Center

Afula, Afula, Israel

Assuta Ashdod Medical Center

Ashdod, Ashdod, Israel

Bnai-Zion Medical Center

Haifa, Haifa District, Israel

Rambam Health Care Campus

Haifa, Haifa District, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Rabin Medical Center (Beilinson Hospital)

Petah Tikva, Petah Tikva, Israel

The Chaim Sheba Medical Center at Tel HaShomer

Ramat Gan, Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, Israel

Barzilai Medical Center

Ashkelon, Israel

Soroka University Medical Center

Beersheba, Israel

Meir Medical Center

Kfar Saba, Israel

View Full Details on ClinicalTrials.gov

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NCT04414475

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