A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05650632
• Other study ID #: M24-108
• Secondary ID: 2023-504674-38-0
• Status: Recruiting
• Phase: Phase 1
• Start date: March 21, 2023
• Est. completion date: July 12, 2026

Study information

• Verified date: February 2024
• Source: TeneoOne Inc.
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 2 Arms; Arm A (Parts 1 and 2) and Arm B. 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. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 12, 2026
• Est. primary completion date: July 12, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have measurable disease as outlined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
• 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 (anti-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] directed against BCMA).

Exclusion Criteria:

• Arm A: Received BCMA-targeted therapy.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• ABBV-383
Intravenous Infusion

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre /ID# 252053	Hamilton	Ontario
Canada	Ottawa Hospital Research Institute /ID# 252151	Ottawa	Ontario
Denmark	Odense Universitets Hospital /ID# 251261	Odense C	Syddanmark
Denmark	Sygehus Lillebalt, Vejle /ID# 251260	Vejle	Syddanmark
France	Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 252101	Créteil
France	Institut Paoli-Calmettes /ID# 252100	Marseille	Bouches-du-Rhone
France	CHU de Nantes, Hotel Dieu -HME /ID# 251196	Nantes	Pays-de-la-Loire
France	AP-HP - Hopital Saint-Antoine /ID# 252326	Paris
France	HCL - Hopital Lyon Sud /ID# 251223	Pierre Benite CEDEX	Rhone
France	CHU Poitiers - La miletrie /ID# 251219	Poitiers	Vienne
Israel	Rabin Medical Center /ID# 251330	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 252079	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 251329	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 251573	Tel Aviv	Tel-Aviv
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 251545	Majadahonda	Madrid
Spain	Hospital Universitario de Salamanca /ID# 251529	Salamanca
Spain	Hospital Universitario Marques de Valdecilla /ID# 251528	Santander	Cantabria
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 251357	London
United Kingdom	The Christie Hospital /ID# 251774	Manchester
United States	University of North Carolina /ID# 251203	Chapel Hill	North Carolina
United States	University of Cincinnati /ID# 251746	Cincinnati	Ohio
United States	Vanderbilt Ingram Cancer Center /ID# 252470	Nashville	Tennessee
United States	Tulane University /ID# 251204	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167	New York	New York
United States	Mt Sinai /ID# 251166	New York	New York
United States	Mayo Clinic Arizona /ID# 251405	Phoenix	Arizona
United States	Mayo Clinic - Rochester /ID# 251164	Rochester	Minnesota
United States	Wake Forest Univ HS /ID# 251165	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
TeneoOne Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Israel,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm A (Part 1 and Part 2): Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events	CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines	Up to Day 28
Primary	Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])	AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	Up to Day 28
Secondary	Arm A: Number of Cytokine Release Syndrome (CRS) Events	CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines	Up to 3 Years

External Links

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