Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
Public ClinicalTrials.gov record NCT06169215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Diagnosed Multiple Myeloma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial compares the combination of selinexor, daratumumab and hyaluronidase-fihj (daratumumab), velcade (bortezomib), and dexamethasone (Dara-SVD) to the usual treatment of daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVD) in treating patients with high-risk newly diagnosed multiple myeloma. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Bortezomib blocks several molecular pathways in a cell and may cause cancer cells to die. It is a type of proteasome inhibitor and a type of dipeptidyl boronic acid. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The drugs daratumumab, lenalidomide, bortezomib, dexamethasone and selinexor are already approved by the Food and Drug Administration for use in myeloma. But selinexor is not used until myeloma comes back (relapses) after initial treatment. Giving selinexor in the initial treatment may be a superior type of treatment for patients with high-risk newly diagnosed multiple myeloma.
Study identification
- NCT ID
- NCT06169215
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Bone Marrow Aspiration Procedure
- Bone Marrow Biopsy Procedure
- Bortezomib Drug
- Computed Tomography Procedure
- Daratumumab and Recombinant Human Hyaluronidase Drug
- Dexamethasone Drug
- Lenalidomide Drug
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
- Selinexor Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 23, 2024 (Actual)
- Primary completion
- Apr 15, 2026 (Actual)
- Completion
- Sep 23, 2027 (Estimated)
- Last update posted
- Sep 25, 2026
2024 – 2027
United States locations
- U.S. sites
- 27
- U.S. states
- 8
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | — |
| UCI Health Laguna Hills | Laguna Hills | California | 92653 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut | 06418 | — |
| Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut | 06824 | — |
| Smilow Cancer Hospital Care Center at Glastonbury | Glastonbury | Connecticut | 06033 | — |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | — |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | 06437 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | 06473 | — |
| Smilow Cancer Hospital Care Center at Long Ridge | Stamford | Connecticut | 06902 | — |
| Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut | 06790 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | 06708 | — |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | 06385 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| NYU Langone Hospital - Brooklyn | Brooklyn | New York | 11220 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Smilow Cancer Hospital Care Center - Westerly | Westerly | Rhode Island | 02891 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06169215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06169215 live on ClinicalTrials.gov.