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)
18 Years and older, Male and Female
M25-025 (primary)
NCI-2026-03665
2025-523517-29
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
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.