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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523517-29 | Other Identifier | EU CT |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-438 | Drug | Intravenous (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Approximately 69.5 Months |
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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:
Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center /ID# 280273 | Recruiting | Duarte | California | 91010 | United States | |
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| 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. |
| 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. | 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. | Up to Approximately 69.5 Months |
| Overall survival (OS) | OS is defined as time from first study treatment to death due to any cause. | 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. | Up to Approximately 69.5 Months |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-438 | Maximum observed plasma concentration of ABBV-438. | Up to Approximately 69.5 Months |
| Time to Cmax (Tmax) of ABBV-438 | Time to Cmax of ABBV-438. | Up to Approximately 69.5 Months |
| t1/2 (Half-life) of ABBV-438 | Half-life of ABBV-438. | Up to Approximately 69.5 Months |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067 |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| Colorado Blood Cancer Institute /ID# 280275 | Recruiting | Denver | Colorado | 80218 | United States |
| City Of Hope - Atlanta. /ID# 280294 | Recruiting | Newnan | Georgia | 30265 | United States |
| START Midwest /ID# 279035 | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| The Chaim Sheba Medical Center /ID# 279065 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 279066 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 278865 | Recruiting | Jerusalem | 91120 | Israel |
| The Cancer Institute Hospital Of JFCR /ID# 279069 | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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