ABBV-383 for Neoplasms, Plasma Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neoplasms, Plasma Cell+2 More
ABBV-383 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is assessing the safety and toxicity of ABBV-383 in combination with other drugs for the treatment of relapsed or refractory multiple myeloma.

Eligible Conditions
  • Neoplasms, Plasma Cell
  • Relapsed Or Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to Approximately 3 Years

Year 3
Duration of Response (DOR)
Number of Participants with Adverse Events (AEs)
Overall Response Rate (ORR)
Percentage of Participants with Minimal Residual Disease Negativity (MRD)
Progression-Free Survival (PFS)
Time-to-Progression (TTP)
Day 28
Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
1 of 4
Arm D (ABBV-383 with Nirogacestat)
1 of 4
Arm C (ABBV-383 with Daratumumab and Dexamethasone)
1 of 4
Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
1 of 4

Experimental Treatment

270 Total Participants · 4 Treatment Groups

Primary Treatment: ABBV-383 · No Placebo Group · Phase 1

Arm A (ABBV-383 with Pomalidomide and Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Pomalidomide, ABBV-383 · Intervention Types: Drug, Drug, Drug
Arm D (ABBV-383 with Nirogacestat)Experimental Group · 2 Interventions: Nirogacestat, ABBV-383 · Intervention Types: Drug, Drug
Arm C (ABBV-383 with Daratumumab and Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Daratumumab, ABBV-383 · Intervention Types: Drug, Drug, Drug
Arm B (ABBV-383 with Lenalidomide and Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Lenalidomide, ABBV-383 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2420
Daratumumab
2016
Completed Phase 4
~1340
Lenalidomide
2005
Completed Phase 3
~1590
Pomalidomide
2011
Completed Phase 2
~1330

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 3 years

Who is running the clinical trial?

TeneoOne Inc.Lead Sponsor
2 Previous Clinical Trials
214 Total Patients Enrolled
2 Trials studying Neoplasms, Plasma Cell
214 Patients Enrolled for Neoplasms, Plasma Cell
TeneoOne IncStudy DirectorTeneoOne Inc.
1 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Neoplasms, Plasma Cell
214 Patients Enrolled for Neoplasms, Plasma Cell

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received prior MM treatment in Arms A, B, C, and D.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.