Trial · NCT04445701
Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
NCT04445701, Phase 1, Phase 2, Completed, Arch Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma. Trials, record NCT04445701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04445701
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT04445701
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Arch Oncology
- Conditions
- Multiple Myeloma
- Interventions
- AO-176, AO-176 + Dex, AO-176 + Dex + Bort
- First posted
- 2020-06-24
- Last updated
- 2023-08-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: MTD / RP2D of AO-176 assessed by incidence of dose-limiting toxicities and incidence of treatment-related adverse events (TEAEs) as assessed by CTCAE v5.0 | 12 months | Safety and tolerability of AO-176 when administered as monotherapy and in combination with dexamethasone or with dexamethasone plus bortezomib in adult patients with R/R MM as assessed by incidence of DLTs and TEAEs as assessed by CTCAE v5.0 |
| Primary | Phase 2: Objective response rate (ORR) of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on ORR using International Myeloma Working Group (IMWG) uniform response criteria |
| Secondary | Phase 1: ORR of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on ORR using IMWG uniform response criteria |
| Secondary | Phase 1: Duration of response (DOR) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on DOR using IMWG uniform response criteria |
| Secondary | Phase 1: Disease control rate (DCR) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on DCR using IMWG uniform response criteria |
| Secondary | Phase 1: Progression-free survival (PFS) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on PFS using IMWG uniform response criteria |
| Secondary | Phase 1: Overall survival (OS) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on OS |
| Secondary | Phase 2: DOR of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on DOR using IMWG uniform response criteria |
| Secondary | Phase 2: DCR of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on DCR using IMWG uniform response criteria |
| Secondary | Phase 2: PFS of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on PFS using IMWG uniform response criteria |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33431660 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT04445701
GET https://conductscience.org/api/trials/v1/NCT04445701/registered