NCT06158841: Phase 3: Intravenous (IV) ABBV-383 Monotherapy Versus Standard Therapies Relapsed/Refractory Myeloma

• NCT06158841: Phase 3: Intravenous (IV) ABBV-383 Monotherapy Versus Standard Therapies RRMM

• Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. . In Arm A, participants will receive ABBV-383 as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.

ABBV-383 - Participants will receive ABBV-383 as a monotherapy.

Standard Available Therapy (SAT) - SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).

Sponsor

Abbvie

Multiple Locations

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ClinicalTrials.gov Identifier: NCT06158841

Official Title: A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

First Posted : December 6, 2023

Click here to see details on ClinicalTrials.gov

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Drug: ABBV-383

Drug: Carfilzomib

Drug: Pomalidomide

Drug: Elotuzumab

Drug: Selinexor

Drug: Bortezomib

Drug: Dexamethasone

ABBV-383 (formerly TNB-383B)

TNB-383B

anti-alpha BCMA/anti-alpha CD3 T-cell engaging bispecific antibody TNB-383B

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* TNB-383B

* anti-BCMA x aCD3 T-BsAb TNB-383B

* anti-BCMA x aCD3 T-cell engaging bispecific antibody TNB-383B

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Locations

Multiple