Multiple MyelomaPhase 1NCT07409246
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 study testing ABBV-438 in people with Multiple Myeloma, run by AbbVie at 14 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ABBV-438
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 27 Feb 2026to Nov 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 4 countries
United States7 sites, 7 recruiting
- Recruiting
University of Chicago Medical Center /ID# 278863
Chicago, Illinois, 60637
- Recruiting
Colorado Blood Cancer Institute /ID# 280275
Denver, Colorado, 80218
- Recruiting
City of Hope National Medical Center /ID# 280273
Duarte, California, 91010
- Recruiting
START Midwest /ID# 279035
Grand Rapids, Michigan, 49546
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067
Irvine, California, 92618
- Recruiting
City Of Hope - Atlanta /ID# 280294
Newnan, Georgia, 30265
- Recruiting
Moffitt Cancer Center /ID# 279068
Tampa, Florida, 33612
Israel3 sites, 3 recruiting
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 278865
Jerusalem, 91120
- Recruiting
The Chaim Sheba Medical Center /ID# 279065
Ramat Gan, Tel Aviv, 5265601
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 279066
Tel Aviv, Tel Aviv, 6423906
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 279207
Hangzhou, Zhejiang, 310009
- Recruiting
Institute of Hematology and Blood Diseases Hospital /ID# 279208
Tianjin, Tianjin Municipality, 300020
Japan2 sites, 2 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital /ID# 279070
Bunkyo Ku, Tokyo, 113-8677
- Recruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 279069
Koto-ku, Tokyo, 135-8550
About this study
Official 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
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.
Read more
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
- Being tested
- ABBV-438
- Keywords
- Multiple Myeloma, ABBV-438, Cancer
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-438Drug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: ABBV-438 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Approximately 69.5 Months
Secondary outcomes (9)
Overall Response Rate (ORR)
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.
Measured: Up to Approximately 69.5 Months
Number of Participants Achieving VGPR or Better
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.
Measured: Up to Approximately 69.5 Months
Duration of Response (DOR) in Participants who Achieved PR or VGPR or CR or sCR
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.
Measured: Up to Approximately 69.5 Months
Progression-free survival (PFS)
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.
Measured: Up to Approximately 69.5 Months
Overall survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Measured: Up to Approximately 69.5 Months
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-438
Area under the plasma concentration-time curve of ABBV-438.
Measured: Up to Approximately 69.5 Months
Maximum Observed Plasma Concentration (Cmax) of ABBV-438
Maximum observed plasma concentration of ABBV-438.
Measured: Up to Approximately 69.5 Months
Time to Cmax (Tmax) of ABBV-438
Time to Cmax of ABBV-438.
Measured: Up to Approximately 69.5 Months
t1/2 (Half-life) of ABBV-438
Half-life of ABBV-438.
Measured: Up to Approximately 69.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start27 Feb 2026
- Primary completionNov 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409246
- Sponsor's protocol ID
- M25-025
- Other IDs
- 2025-523517-29, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07409246
- Acronym / sponsor ID
- M25-025
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, ABBV-438, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-438 Monotherapy Dose Escalation | Experimental | Drug: ABBV-438Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration. |
| Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A) | Experimental | Drug: ABBV-438Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration. |
| Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B) | Experimental | Drug: ABBV-438Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-438Intravenous (IV) | Drug | 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) |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to Approximately 69.5 Months
Number of Participants Achieving VGPR or Better
Time frame: Up to Approximately 69.5 Months
Duration of Response (DOR) in Participants who Achieved PR or VGPR or CR or sCR
Time frame: Up to Approximately 69.5 Months
Progression-free survival (PFS)
Time frame: Up to Approximately 69.5 Months
Overall survival (OS)
Time frame: Up to Approximately 69.5 Months
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-438
Time frame: Up to Approximately 69.5 Months
Maximum Observed Plasma Concentration (Cmax) of ABBV-438
Time frame: Up to Approximately 69.5 Months
Time to Cmax (Tmax) of ABBV-438
Time frame: Up to Approximately 69.5 Months
t1/2 (Half-life) of ABBV-438
Time frame: Up to Approximately 69.5 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-438 in people with Multiple Myeloma, run by AbbVie at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Israel, China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AE) (time frame: Up to Approximately 69.5 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.