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Proteasome Inhibitor

Arm I (Dara-SVD) 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Deep clinical response

Secondary outcome measures

Minimal residual disease-negativity (10^-5)

Other outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Dara-SVD)Experimental Treatment10 Interventions

Patients receive daratumumab and hyaluronidase-fihj SC or daratumumab IV 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 biopsy and collection of blood samples during screening and at the end of treatment.

Group II: Arm II (Dara-RVD)Active Control10 Interventions

Patients receive daratumumab and hyaluronidase-fihj SC or daratumumab IV 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 biopsy and collection of blood samples during screening and at the end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Selinexor

2020

Completed Phase 2

~1360

Computed Tomography

2017

Completed Phase 2

~2720

Bortezomib

2005

Completed Phase 2

~1090

Positron Emission Tomography

2008

Completed Phase 2

~2240

Dexamethasone

2007

Completed Phase 4

~2590

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Daratumumab

2014

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,675 Previous Clinical Trials

40,926,906 Total Patients Enrolled

581 Trials studying Multiple Myeloma

189,131 Patients Enrolled for Multiple Myeloma

Natalia NeparidzePrincipal InvestigatorYale University Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Dara-SVD in Arm I been officially sanctioned by the FDA?

"Based on our assessment at Power, Arm I (Dara-SVD) has been rated a 2 in terms of safety. This rating reflects the existing data supporting its safety profile but not yet confirming its efficacy given the Phase 2 trial status."

Answered by AI

Are patients currently being accepted to participate in this research study?

"Indeed, as per clinicaltrials.gov data, this investigation is actively seeking volunteers. The trial was first listed on 11/16/2024 and most recently revised on 3/6/2024. It aims to enlist 70 participants from a single site."

Answered by AI

What is the upper limit for the number of participants involved in this medical study?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this trial. The initial posting date was 16th November 2024, with the most recent update made on 6th March 2024. A total of 70 patients are being sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma

2024. "Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169215.