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)

NCT07409246 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: M25-0252025-523517-29
• Study Type: interventional
• Target: 127
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Multiple Myeloma

Keywords

Multiple Myeloma; ABBV-438; Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to Approximately 69.5 Months

Secondary Outcomes (9)

• Overall Response Rate (ORR)

  Up to Approximately 69.5 Months

• Number of Participants Achieving VGPR or Better

  Up to Approximately 69.5 Months

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

  Up to Approximately 69.5 Months

• Progression-free survival (PFS)

  Up to Approximately 69.5 Months

• Overall survival (OS)

  Up to Approximately 69.5 Months

Study Arms (3)

Part 1: ABBV-438 Monotherapy Dose Escalation

EXPERIMENTAL

Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration.

Drug: ABBV-438

Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A)

EXPERIMENTAL

Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration.

Drug: ABBV-438

Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B)

EXPERIMENTAL

Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration.

Drug: ABBV-438

Interventions

ABBV-438 DRUG

Intravenous (IV)

Part 1: ABBV-438 Monotherapy Dose Escalation; Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A); Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

City of Hope National Medical Center /ID# 280273

Duarte, California, 91010, United States

RECRUITING

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067

Irvine, California, 92618, United States

RECRUITING

Colorado Blood Cancer Institute /ID# 280275

Denver, Colorado, 80218, United States

RECRUITING

City Of Hope - Atlanta. /ID# 280294

Newnan, Georgia, 30265, United States

RECRUITING

START Midwest /ID# 279035

Grand Rapids, Michigan, 49546, United States

RECRUITING

The Chaim Sheba Medical Center /ID# 279065

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 279066

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 278865

Jerusalem, 91120, Israel

RECRUITING

The Cancer Institute Hospital Of JFCR /ID# 279069

Koto-ku, Tokyo, 135-8550, Japan

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 13, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); IL (3); JP (1)