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Proteasome Inhibitor

Selinexor Combination Therapy for Multiple Myeloma

Phase 2

Recruiting

Led By Natalia Neparidze

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to end of cycle 4 (each cycle = 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing a new combination of drugs called Dara-SVD to the standard treatment of Dara-RVD for patients with high-risk newly diagnosed multiple myeloma. The new combination includes a

Who is the study for?

This trial is for patients with newly diagnosed high-risk multiple myeloma who may have had one cycle of bortezomib-based therapy. They should not have severe liver or kidney issues, and their immune system must be functioning at a certain level. People with HIV can join if they're on effective treatment.

What is being tested?

The study compares Dara-SVD (selinexor, daratumumab, Velcade/bortezomib, dexamethasone) to the usual Dara-RVD (daratumumab, lenalidomide, Velcade/bortezomib, dexamethasone). It's testing whether adding selinexor early in treatment offers better outcomes for those with aggressive myeloma.

What are the potential side effects?

Possible side effects include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems. There might also be nerve damage from bortezomib and steroid-related issues like increased blood sugar from dexamethasone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of cycle 4 (each cycle = 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of cycle 4 (each cycle = 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of cycle 4 (each cycle = 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Deep clinical response

Secondary study objectives

Minimal residual disease-negativity (10^-5)

Other study objectives

Ribonucleic acid (RNA) and cell free deoxyribonucleic acid (DNA) sequencing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Dara-SVD)Experimental Treatment11 Interventions

Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, \& 22 for cycles 1-2, then days 1 \& 15 for cycles 3-4, and selinexor PO, bortezomib SC, and dexamethasone PO on days 1, 8, 15, \& 22 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET, MRI, or CT, and bone marrow aspiration and biopsy, and collection of blood and urine samples throughout the study.

Group II: Arm II (Dara-RVD)Active Control11 Interventions

Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, \& 22 for cycles 1-2, then days 1 \& 15 for cycles 3-4, lenalidomide PO QD on days 1-21 of each cycle, and bortezomib SC and dexamethasone PO on days 1, 8, 15, \& 22 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET, MRI, or CT, and bone marrow aspiration and biopsy, and collection of blood and urine samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180