Clinical trial NCT05650632: A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Cancer
ABBV-383
B-Cell Maturation Antigen
Lead sponsor: TeneoOne Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility criteria: Inclusion Criteria:

* Must have measurable disease as outlined in the protocol.
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C only: ECOG performance of \<= 1.
* Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
* Must be naïve to treatment with ABBV-383.
* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of ABBV-383.

Exclusion Criteria:

* Arm A: Received BCMA-targeted therapy.
* Arm C: Rapidly progressing disease per investigator.

Primary outcomes:
measure: Arm A (Part 1 and Part 2) and Arm C: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
timeFrame: Up to Day 28
measure: Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])
timeFrame: Up to Day 28
Secondary outcomes:
measure: Arm A and Arm C: Number of Cytokine Release Syndrome (CRS) Events
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 251405
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group - Springdale /ID# 267742
state: Arkansas
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora /ID# 268574
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants /ID# 268560
state: Delaware
city: Hinsdale
country: United States
facility: Hope And Healing Cancer Services /ID# 268536
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology And Hematology /ID# 268179
state: Indiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine /ID# 251204
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 251164
state: Minnesota
city: Lincoln
country: United States
facility: NHO Revive Research Institute, LLC /ID# 267869
state: Nebraska
city: New York
country: United States
facility: Mt Sinai /ID# 251166
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina /ID# 251203
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ HS /ID# 251165
state: North Carolina
city: Cincinnati
country: United States
facility: University Of Cincinnati Medical Center /ID# 251746
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center /ID# 267088
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center /ID# 252470
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Central/South Texas /ID# 268563
state: Texas
city: Houston
country: United States
facility: Oncology Consultants /ID# 268323
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 268877
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 268559
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center /ID# 267940
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties Tacoma /ID# 267117
state: Washington
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 252053
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 252151
state: Ontario
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 251261
state: Syddanmark
city: Vejle
country: Denmark
facility: Sygehus Lillebalt, Vejle /ID# 251260
state: Syddanmark
city: Marseille
country: France
facility: Institut Paoli-Calmettes /ID# 252100
state: Bouches-du-Rhone
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101
state: Paris
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 251196
state: Pays-de-la-Loire
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 251223
state: Rhone
city: Poitiers
country: France
facility: CHU Poitiers - La miletrie /ID# 251219
state: Vienne
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 252326
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 251329
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 251573
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 252079
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 251330
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 251528
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545
state: Madrid
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 251529
city: London
country: United Kingdom
facility: University College London Hospital /ID# 251357
state: Greater London
city: Manchester
country: United Kingdom
facility: The Christie Hospital /ID# 251774
Study officials:
affiliation: TeneoOne Inc.
name: TeneoOne Inc
role: STUDY_DIRECTOR
References: