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NCT Number: 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)

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Chaim Sheba Medical Center /ID# 279065, Ramat Gan, Tel Aviv, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

ABBV-438

Drug

Intravenous (IV)

Primary outcomes

  1. Number of Participants With Adverse Events (AE)

    Time frame: 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.

  2. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

    Time frame: Up to Approximately 69.5 Months

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

  3. Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters

    Time frame: Up 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.

  4. Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)

    Time frame: Up to Approximately 69.5 Months

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

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to Approximately 69.5 Months

    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.

  2. Number of Participants Achieving VGPR or Better

    Time frame: Up to Approximately 69.5 Months

    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.

  3. Duration of Response (DOR) in Participants who Achieved PR or VGPR or CR or sCR

    Time frame: Up to Approximately 69.5 Months

    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.

  4. Progression-free survival (PFS)

    Time frame: Up to Approximately 69.5 Months

    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.

  5. Overall survival (OS)

    Time frame: Up to Approximately 69.5 Months

    OS is defined as time from first study treatment to death due to any cause.

  6. Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-438

    Time frame: Up to Approximately 69.5 Months

    Area under the plasma concentration-time curve of ABBV-438.

  7. Maximum Observed Plasma Concentration (Cmax) of ABBV-438

    Time frame: Up to Approximately 69.5 Months

    Maximum observed plasma concentration of ABBV-438.

  8. Time to Cmax (Tmax) of ABBV-438

    Time frame: Up to Approximately 69.5 Months

    Time to Cmax of ABBV-438.

  9. t1/2 (Half-life) of ABBV-438

    Time frame: Up to Approximately 69.5 Months

    Half-life of ABBV-438.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Feb 13, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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