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Study of ABBV-438 for Relapsed/Refractory Multiple Myeloma

This study is testing an investigational drug called ABBV-438 for adults with multiple myeloma (a type of blood cancer) that has returned or not responded to previous treatments (relapsed or refractory MM). The main goals are to understand the safety of ABBV-438, how well your body tolerates it, and how the drug moves through your system. Researchers will look for side effects and changes in your health. You may be eligible if your multiple myeloma has progressed after your last treatment. This study aims to find the best dose of ABBV-438 and then confirm that dose.

Study design
This interventional study plans to enroll 127 participants. It will involve two parts: first, finding the best dose of ABBV-438, and then confirming that dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for adverse events and changes in laboratory and vital sign parameters for up to approximately 69.5 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07409246

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~127 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:ABBV-438

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AE)
Measured over Up to Approximately 69.5 Months
+3 more outcomes measured

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

11 sites across 9 states
California2
Tel Aviv2
Colorado1
Florida1
Georgia1
Michigan1
Tianjin Municipality1
Israel1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of Participants With Adverse Events (AE)Up to Approximately 69.5 Months

    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.

  • Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory ParametersUp to Approximately 69.5 Months

    Clinical laboratory parameters included tests of hematology and chemistry. The investigator will assess the results for clinical significance.

  • Number of Participants With Clinically Significant Changes From Baseline in Vital Sign ParametersUp to Approximately 69.5 Months

    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.

  • Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)Up to Approximately 69.5 Months

    A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.