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

Sponsor

TeneoOne Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05650632

Collaborator

(none)

Enrollment

Locations

Arms

37.9

Anticipated Duration (Months)

6.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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 will be used followed by the target dose of ABBV-383. Around 80 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: ABBV-383	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 30, 2026

Anticipated Study Completion Date :

May 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABBV-383 Dose Escalation Participants will receive different doses of ABBV-383 in 28 day cycles.	Drug: ABBV-383 Intravenous Infusion
Experimental: ABBV-383 Dose Expansion Participants will receive ABBV-383 in 28 day cycles.	Drug: ABBV-383 Intravenous Infusion

Arm

Intervention/Treatment

Experimental: ABBV-383 Dose Escalation

Participants will receive different doses of ABBV-383 in 28 day cycles.

Drug: ABBV-383

Intravenous Infusion

Experimental: ABBV-383 Dose Expansion

Participants will receive ABBV-383 in 28 day cycles.

Drug: ABBV-383

Intravenous Infusion

Outcome Measures

Primary Outcome Measures

Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [Up to Day 28]
CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Secondary Outcome Measures

Number of Cytokine Release Syndrome (CRS) Events [Up to 3 Years]
CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

Exclusion Criteria:

Received B-cell maturation antigen (BCMA)-targeted therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona /ID# 251405	Phoenix	Arizona	United States	85054
2	Tulane University /ID# 251204	New Orleans	Louisiana	United States	70112-2005
3	Mayo Clinic - Rochester /ID# 251164	Rochester	Minnesota	United States	55905-0001
4	Mt Sinai /ID# 251166	New York	New York	United States	10029-6542
5	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167	New York	New York	United States	10065-6007
6	Wake Forest Univ HS /ID# 251165	Winston-Salem	North Carolina	United States	27157
7	HCL - Hopital Lyon Sud /ID# 251223	Pierre Benite CEDEX	Auvergne-Rhone-Alpes	France	69495
8	The Chaim Sheba Medical Center /ID# 251329	Ramat Gan	Tel-Aviv	Israel	5265601
9	Tel Aviv Sourasky Medical Center /ID# 251573	Tel Aviv-Yafo	Tel-Aviv	Israel	6423906
10	Hadassah Medical Center-Hebrew University /ID# 252079	Jerusalem	Yerushalayim	Israel	91120
11	Rabin Medical Center /ID# 251330	Petakh Tikva		Israel	4941492
12	Nottingham University Hospitals NHS Trust /ID# 251358	Nottingham	Nottinghamshire	United Kingdom	NG5 1PB
13	The Christie Hospital /ID# 251774	Manchester		United Kingdom	M20 4BX