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NCT04445701 · ClinicalTrials.gov registry record · Phase 1

Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

A Phase 1 study of Multiple Myeloma, sponsored by Arch Oncology.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
6
Study locations

NCT04445701: Completed Phase 1 study of Multiple Myeloma, sponsored by Arch Oncology.

NCT04445701 is a Phase 1 study of Multiple Myeloma that has completed, run by Arch Oncology. The registered enrollment target is 10 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04445701, a Phase 1 study of Multiple Myeloma, has completed, sponsored by Arch Oncology.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
6
Study locations

Study Summary

Open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics and initial efficacy of AO-176 as monotherapy and in combination with dexamethasone and bortezomib in adults with relapsed/refractory multiple myeloma (MM).

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG AO-176
  • DRUG AO-176 + Dex
  • DRUG AO-176 + Dex + Bort

Study Locations (6)

Arizona

  • Mayo Clinic - Phoenix

Florida

  • Mayo Clinic - Jacksonville

Georgia

  • Emory University - Atlanta

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Minnesota

  • Mayo Clinic - Rochester

Wisconsin

  • Medical College of Wisconsin and Froedtert Hospital - Milwaukee

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-11-30
Est. Completion 2022-11-14
Phase Phase 1
Arch Oncology

2 total trials

What the finished NCT04445701 record still lists

NCT04445701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which AO-176 is the first listed.

NCT04445701 lists 6 locations in 6 states (Arizona, Florida, Georgia).

Frequently Asked Questions

What is clinical trial NCT04445701 about?

NCT04445701 is a clinical study titled "Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma". Open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics and initial efficacy of AO-176 as monotherapy and in combination with dexamethasone and bortezomib in adults with relapsed/refractory multiple myeloma (MM).

What is the current status of trial NCT04445701?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-11-30. Estimated completion is 2022-11-14.

What conditions does trial NCT04445701 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT04445701?

The interventions under investigation include: AO-176 (DRUG), AO-176 + Dex (DRUG), AO-176 + Dex + Bort (DRUG).

Who is sponsoring clinical trial NCT04445701?

This trial is sponsored by Arch Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04445701 being conducted?

This trial has 6 study locations across Arizona, Florida, Georgia, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT04445701's enrollment target sits among peer trials

10 419th of 438 higher than 14 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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Source: ClinicalTrials.gov NCT04445701, the US trial registry maintained by the National Library of Medicine. NCT04445701 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.