Trial · NCT07082270
Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT07082270, Phase 1, Withdrawn, Roswell Park Cancer Institute
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma. Trials, record NCT07082270. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07082270
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT07082270
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- Interventions
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Carfilzomib, Computed Tomography, Daratumumab and Recombinant Human Hyaluronidase, Dexamethasone, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Positron Emission Tomography, Questionnaire Administration, Selvigaltin
- First posted
- 2025-07-24
- Last updated
- 2026-05-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) | Up to 28 days | As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v) 5.0. The DLTs will be summarized by dose level using frequencies and relative frequencies. |
| Primary | Maximum tolerated dose (MTD) | Up to 28 days | Will determine the MTD of selvigaltin when administered in combination with daratumumab, carfilzomib, and dexamethasone (DaraKD). Will employ the Bayesian optimal interval design to find the MTD. |
| Primary | Recommended phase 2 dose (RP2D) | Up to 28 days | Will determine the RP2D of selvigaltin when administered in combination with DaraKD. The RP2D will be determined by evaluating both the toxicity profile and the therapeutic response. |
| Secondary | Incidence of overall adverse events | Up to 6 cycles (Cycle length = 28 days) | As assessed by the NCI CTCAE v5.0. |
| Secondary | Incidence of serious adverse events | Up to 6 cycles (Cycle length = 28 days) | As assessed by the NCI CTCAE v5.0. |
| Secondary | Overall response rate | During or after 6 cycles of therapy, assessed up to 3 years (Cycle length = 28 days) | As per investigator's assessment using the International Myeloma Working Group criteria will be summarized as proportions and 90% Clopper-Pearson confidence intervals by dose levels. |
| Secondary | Duration of response | During or after 6 cycles of therapy, assessed up to 3 years (Cycle length = 28 days) | |
| Secondary | Progression free survival | From the start of treatment until the first occurrence of disease progression or death from any cause, whichever comes first, assessed up to 3 years | Will be summarized using Kaplan-Meier estimators by dose levels. |
| Secondary | Overall survival | From the start of treatment to death from any cause, assessed up to 3 years | Will be summarized using Kaplan-Meier estimators by dose levels. |
| Secondary | Patient reported outcomes | At baseline, cycle 4 day 1, and 30 days after last dose of study drug | As assessed using the European Organization for the Research and Treatment of Cancer Quality of Life-Core 30 questionnaire. Will be summarized by dose levels and time points. Generalized linear mixed models will be used for within-subject comparisons between time points. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Grants1
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 |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source 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/NCT07082270
GET https://conductscience.org/api/trials/v1/NCT07082270/registered