Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Subcutaneous (SC) ABBV-383; Drug: Intravenous (IV) ABBV-383

Study type: Interventional

Funder types: Industry

Identifiers

NCT06223516

2023-507901-32-00 (Other Identifier)

M23-001

Details and patient eligibility

About

Multiple myeloma (MM) is a cancer of the blood's plasma cells. 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 the safety and pharmacokinetics 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 MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world

In Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.

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: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
• Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.
• Must be naïve to treatment with ABBV-383.

Exclusion criteria

• Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

ABBV-383 Dose A

Experimental group

Description:

Participants will receive Dose A of ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.

Treatment:

Drug: Intravenous (IV) ABBV-383

Drug: Subcutaneous (SC) ABBV-383

ABBV-383 Dose B

Experimental group

Description:

Participants will receive Dose B of ABBV-383 as an SC injection and IV infusions, during the 151 week study duration.

Treatment:

Drug: Intravenous (IV) ABBV-383

Drug: Subcutaneous (SC) ABBV-383

ABBV-383 Expansion

Experimental group

Description:

Participants will receive the selected dose from Arm A of ABBV-383 as SC injections, during the 151 week study duration.

Treatment:

Drug: Subcutaneous (SC) ABBV-383