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NCT06169215 · ClinicalTrials.gov registry record · Phase 2
Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT06169215: Active Phase 2 study of Multiple Myeloma, sponsored by National Cancer Institute (NCI).
NCT06169215 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06169215, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Defined as complete response (CR) + stringent CR.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- DRUG Bortezomib
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UCI Health Laguna Hills - Laguna Hills
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
New York
- NYU Langone Hospital - Brooklyn - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT06169215 still lists
NCT06169215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06169215 names 20 study sites across 4 states, led by Connecticut, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT06169215 about?
NCT06169215 is a clinical study titled "Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma". 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 diag...
What is the current status of trial NCT06169215?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-07-23. Estimated completion is 2026-09-30.
What conditions does trial NCT06169215 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT06169215?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT06169215?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06169215 being conducted?
This trial has 20 study locations across California, Connecticut, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06169215's enrollment target sits among peer trials
70 212th of 438 higher than 225 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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