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NCT07409246From ClinicalTrials.govRecruiting

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)

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

  • Multiple Myeloma

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
AbbVie
Enrolment target
127
Started
27 February 2026
Main results due
November 2031
Study sites
13
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(13)

  • City of Hope National Medical Center /ID# 280273

    Duarte, California, United States

    Recruiting

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

    Irvine, California, United States

    Recruiting

  • Colorado Blood Cancer Institute /ID# 280275

    Denver, Colorado, United States

    Recruiting

  • Moffitt Cancer Center /ID# 279068

    Tampa, Florida, United States

    Recruiting

  • City Of Hope - Atlanta /ID# 280294

    Newnan, Georgia, United States

    Recruiting

  • University of Chicago Medical Center /ID# 278863

    Chicago, Illinois, United States

    Recruiting

  • START Midwest /ID# 279035

    Grand Rapids, Michigan, United States

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital /ID# 279208

    Tianjin, Tianjin Municipality, China

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 279207

    Hangzhou, Zhejiang, China

    Recruiting

  • The Chaim Sheba Medical Center /ID# 279065

    Ramat Gan, Tel Aviv, Israel

    Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 279066

    Tel Aviv, Tel Aviv, Israel

    Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 278865

    Jerusalem, Israel

    Recruiting

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 279069

    Koto-ku, Tokyo, Japan

    Recruiting

Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07409246. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Mov | Trialion