Actively Recruiting
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)
Led by AbbVie · Updated on 2026-05-13
127
Participants Needed
4
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has relapsed or refractory Multiple Myeloma with documented progression during or after last treatment
- Has measurable disease at screening defined by specific levels of serum or urine M-protein or serum free light chain
- Has had 3 or more prior lines of therapy including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy
- Is intolerant to or unable to access available therapies known to benefit relapsed or refractory Multiple Myeloma
You will not qualify if you...
- Known history of Central Nervous System involvement by Multiple Myeloma
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
City Of Hope - Atlanta. /ID# 280294
Newnan, Georgia, United States, 30265
Actively Recruiting
2
START Midwest /ID# 279035
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Hadassah Medical Center-Hebrew University /ID# 278865
Jerusalem, Israel, 91120
Actively Recruiting
4
The Cancer Institute Hospital Of JFCR /ID# 279069
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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