RECRUITING Phase 1 ClinicalTrials.gov

A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07409246

Registry updated: 2026-10-20

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed. ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide. Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Interventions

ABBV-438 (Drug)
Intravenous (IV)

Eligibility criteria

Inclusion Criteria: * Has relapsed or refractory 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 standard International Myeloma Working Group (IMWG) (2016) response criteria: * Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy; * Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy. * Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment: * Serum M-protein \>= 0.5 g/dL (\>=5 g/L); OR; * Urine M-protein \>= 200 mg/24 hours; OR; * Involved serum free light chain (sFLC) \>= 10 mg/dL (100mg/L), provided serum FLC ratio is abnormal; * Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R/R) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens. Exclusion Criteria: * Known history of Central Nervous System involvement by MM. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

Conditions

Multiple Myeloma

Locations

City of Hope National Medical Center /ID# 280273 — Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067 — Irvine, California, United States
Colorado Blood Cancer Institute /ID# 280275 — Denver, Colorado, United States
Moffitt Cancer Center /ID# 279068 — Tampa, Florida, United States
City Of Hope - Atlanta /ID# 280294 — Newnan, Georgia, United States
University of Chicago Medical Center /ID# 278863 — Chicago, Illinois, United States
START Midwest /ID# 279035 — Grand Rapids, Michigan, United States
Institute of Hematology and Blood Diseases Hospital /ID# 279208 — Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 279207 — Hangzhou, Zhejiang, China
The Chaim Sheba Medical Center /ID# 279065 — Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 279066 — Tel Aviv, Tel Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 278865 — Jerusalem, Israel
Tokyo Metropolitan Komagome Hospital /ID# 279070 — Bunkyo Ku, Tokyo, Japan
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 279069 — Koto-ku, Tokyo, Japan

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment