NCT07409246RecruitingPhase 1
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)
A Phase 1, First-in-Human, Open Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ABBV-438 in Adult Subjects With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 127 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- 27 Feb 2026
- Primary completion date
- 30 Nov 2031
- Lead sponsor
- AbbVie
- Diseases
- Multiple myeloma
- NCT number
- NCT07409246
- EudraCT number
- 2025-523517-29
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 127
- From 27 Feb 2026 to the primary completion date, 30 Nov 2031
- 14 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 279207 Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Institute of Hematology and Blood Diseases Hospital /ID# 279208 Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 278865 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 279065 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 279066 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Tokyo Metropolitan Komagome Hospital /ID# 279070 Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Recruiting |
| The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 279069 Coordinator of this site? Confirm its status | Koto-ku | Japan | Recruiting |
| University of Chicago Medical Center /ID# 278863 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Colorado Blood Cancer Institute /ID# 280275 Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| City of Hope National Medical Center /ID# 280273 Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| START Midwest /ID# 279035 Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067 Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| City Of Hope - Atlanta /ID# 280294 Coordinator of this site? Confirm its status | Newnan | United States | Recruiting |
| Moffitt Cancer Center /ID# 279068 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.