A Phase 1 interventional study of ABBV-438 in Multiple Myeloma, sponsored by AbbVie. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
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:
Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:
Exclusion Criteria:
Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration.
Drug: ABBV-438
Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration.
Drug: ABBV-438
Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration.
Drug: ABBV-438
Intravenous (IV)
Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.
Time frame: Up to Approximately 69.5 Months
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Clinical laboratory parameters included tests of hematology and chemistry. The investigator will assess the results for clinical significance.
Time frame: Up to Approximately 69.5 Months
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
Time frame: Up to Approximately 69.5 Months
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
Time frame: Up to Approximately 69.5 Months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with the achievement of partial response (PR) or very good partial response (VGPR) or complete response (CR) or stringent complete response (sCR) as assessed by investigators per IMWG 2016 criteria.
Time frame: Up to Approximately 69.5 Months
Number of Participants Achieving VGPR or Better
VGPR or better is defined as the percentage of participants with the achievement of VGPR , CR, or sCR as assessed by investigators per IMWG 2016 criteria.
Time frame: Up to Approximately 69.5 Months
Duration of Response (DOR) in Participants who Achieved PR or VGPR or CR or sCR
DOR is defined as confirmed sCR, CR, VGPR, or PR as the time from the initial response of PR (or better) per investigator review according to IMWG 2016 criteria, to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to Approximately 69.5 Months
Progression-free survival (PFS)
PFS defined as time from first study treatment to a documented disease progression according to IMWG 2016 criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to Approximately 69.5 Months
Overall survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Time frame: Up to Approximately 69.5 Months
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-438
Area under the plasma concentration-time curve of ABBV-438.
Time frame: Up to Approximately 69.5 Months
Maximum Observed Plasma Concentration (Cmax) of ABBV-438
Maximum observed plasma concentration of ABBV-438.
Time frame: Up to Approximately 69.5 Months
Time to Cmax (Tmax) of ABBV-438
Time to Cmax of ABBV-438.
Time frame: Up to Approximately 69.5 Months
t1/2 (Half-life) of ABBV-438
Half-life of ABBV-438.
Time frame: Up to Approximately 69.5 Months
Plan to share: No
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