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

TeneoOne

Status and phase: Enrolling; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: ABBV-383

Study type: Interventional

Funder types: Industry

Identifiers

NCT05650632

M24-108

2023-504674-38-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

Arm A (Part 1): ABBV-383 Dose Escalation

Experimental group

Description:

B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.

Treatment:

Drug: ABBV-383

Arm A (Part 2): ABBV-383 Dose Expansion

Experimental group

Description:

BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.

Treatment:

Drug: ABBV-383

Arm B: ABBV-383 BCMA Exposed

Experimental group

Description:

Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.

Treatment:

Drug: ABBV-383

Arm C: ABBV-383 Step Up

Experimental group

Description:

Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Treatment:

Drug: ABBV-383