Trial · NCT06169215
Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
NCT06169215, Phase 2, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma. Trials, record NCT06169215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06169215
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
- NCT number
- NCT06169215
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Multiple Myeloma
- Interventions
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bortezomib, Computed Tomography, Daratumumab and Recombinant Human Hyaluronidase, Dexamethasone, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography, Selinexor
- First posted
- 2023-12-13
- Last updated
- 2026-09-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Deep clinical response | Up to the end of cycle 4 (each cycle = 28 days) | Defined as complete response (CR) + stringent CR. |
| Secondary | Minimal residual disease-negativity (10^-5) | Up to end of cycle 4 (each cycle = 28 days) | Will be assessed by next generation flow cytometry. |
| Other | Ribonucleic acid (RNA) and cell free deoxyribonucleic acid (DNA) sequencing | Baseline up to end of cycle 4 (each cycle = 28 days) | Will compare pre- and post-treatment RNA and cell free DNA sequencing data to identify unique differential signature correlated with deep responses among subjects treated with selinexor-daratumumab-velcade-dexamethasone regimen. Will use cox proportional hazard models to identify a gene signature predictive of response to selinexor. |
| Other | Venous thromboembolism | Up to 2 years | Venous thromboembolism will be a composite endpoint comprised of adverse events associated with study medications defined according to Common Terminology Criteria for Adverse Events grade, term and system organ class as follows: grades 1-5 thromboembolic events; grades 2-5 portal vein thrombosis; grades 1-5 superior vena cava syndrome; grades 1-5 vascular access complication; grades 3-5 arterial thromboembolism. |
| Other | Incidence of adverse events associated with anticoagulation thromboprophylaxis strategy | Up to 2 years | Will be defined as follows: clinically significant major bleeding events including required transfusion of red blood cells; required admission to the hospital for \> 24 hours; prolonged hospitalization, with bleeding as the principal reason; required surgery to stop the bleeding. |
| Other | Venous thromboembolism risk factors | At baseline and at the time of incidence of venous thromboembolism | All the data comprising two established risk scores, IMPEDE or SAVED, will be collected. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016359 | Cancer Center Support Grant | WINER, ERIC P. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06169215
GET https://conductscience.org/api/trials/v1/NCT06169215/registered