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)
Start Date
2/27/2026
Completion Date
11/1/2031
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABBV-438
Conditions
Locations
City of Hope National Medical Center /ID# 280273
Duarte, California 91010
United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067
Irvine, California 92618
United States
Colorado Blood Cancer Institute /ID# 280275
Denver, Colorado 80218
United States
City Of Hope - Atlanta. /ID# 280294
Newnan, Georgia 30265
United States
START Midwest /ID# 279035
Grand Rapids, Michigan 49546
United States
The Chaim Sheba Medical Center /ID# 279065
Ramat Gan, Tel Aviv 5265601
Israel
Tel Aviv Sourasky Medical Center /ID# 279066
Tel Aviv, Tel Aviv 6423906
Israel
Hadassah Medical Center-Hebrew University /ID# 278865
Jerusalem, 91120
Israel
The Cancer Institute Hospital Of JFCR /ID# 279069
Koto-ku, Tokyo 135-8550
Japan