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New hope for Hard-to-Treat myeloma? early trial of ABBV-438 begins

NCT ID NCT07409246

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This early-stage trial tests an investigational drug called ABBV-438 in about 127 adults with multiple myeloma that has come back or stopped responding to treatment. The study has two parts: first, finding a safe dose, then testing that dose in more people. The main goal is to check safety and how the drug moves through the body, while also looking for signs that it might shrink the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-438
What this could lead to
If successful, this could point toward a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or could have unexpected side effects. It is small and focused on safety, not proof of effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 127 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City Of Hope - Atlanta /ID# 280294

    RECRUITING

    Newnan, Georgia, 30265, United States

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

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 280273

    RECRUITING

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute /ID# 280275

    RECRUITING

    Denver, Colorado, 80218, United States

  • Hadassah Medical Center-Hebrew University /ID# 278865

    RECRUITING

    Jerusalem, 91120, Israel

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

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Moffitt Cancer Center /ID# 279068

    RECRUITING

    Tampa, Florida, 33612, United States

  • START Midwest /ID# 279035

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Tel Aviv Sourasky Medical Center /ID# 279066

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Cancer Institute Hospital Of JFCR /ID# 279069

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Chaim Sheba Medical Center /ID# 279065

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

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