Trial · NCT05514990
Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
NCT05514990, Phase 1, Phase 2, Active not recruiting, University of Southern California
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial. Trials, record NCT05514990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05514990
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
- NCT number
- NCT05514990
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
- Bortezomib, Dexamethasone, Pelareorep, Pembrolizumab
- First posted
- 2022-08-25
- Last updated
- 2026-05-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) (Phase 1B) | During the 21 days of cycle 1 | Incidence of dose-limiting toxicities resulting from pelareorep (PELA) in combination with bortezomib-dexamethasone (BOR-D) and pembrolizumab will be assessed. Severity of Adverse Events (AEs) will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Primary | Incidence and severity of adverse events (AEs) (Phase 1B) | Up to 30 days following cessation of study intervention | Incidence and severity of adverse events (AEs) will be graded according to NCI CTCAE version 5.0, and changes in clinical laboratory parameters. |
| Primary | Overall response rate (ORR) (complete response [CR] + partial response [PR]) (Phase 2) | Up to 3 years | Overall response rate, complete response partial response per the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM). |
| Secondary | ORR (CR + PR) (Phase 1B) | Up to 3 years | ORR (CR + PR) per the IMWG Uniform Response Criteria for MM |
| Secondary | Duration of response (DOR) (Phase 2) | Up to 3 years | Time from first documentation of response (PR or greater) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first. |
| Secondary | Progression-free survival (PFS) (Phase 2) | Up to 3 years | Time from the date of first study treatment to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. |
| Secondary | Overall survival (OS) (Phase 2) | Up to 3 years | Defined as the time from the first study treatment administration to death from any cause. |
| Secondary | Incidence of adverse events (Phase 2) | From the time of intervention allocation through 90 days following cessation of study intervention or 30 days following cessation of study intervention | Type, frequency, and severity of AEs, using the NCI CTCAE version 5.0. |
| Secondary | Severity of serious adverse events (Phase 2) | From the time of intervention allocation through 90 days following cessation of study intervention or 30 days following cessation of study intervention | Serious adverse events (SAEs), using the NCI CTCAE version 5.0. |
| Other | Changes in gene expression (Phase 1B, Phase 2) | Up to 3 years | Will identify biological changes between pre-treatment and on-treatment biopsies as defined by changes in gene expression within the tumor microenvironment (TME). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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 |
|---|---|---|---|---|---|
| P30CA014089 | University of Southern California Norris Comprehensive Cancer Center Support Grant (CCSG) | LERMAN, CARYN | UNIVERSITY OF SOUTHERN CALIFORNIA | 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/NCT05514990
GET https://conductscience.org/api/trials/v1/NCT05514990/registered