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Multiple myeloma (MM) is an incurable disease characterized by the growth of monoclonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease state of etentamig in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Two doses of ABBV-383 will be explored. Each treatment arm receives a different dose of ABBV-383 to determine a tolerable dose. Approximately 12 adult participants with R/R MM will be enrolled in the study in approximately 6 sites in Japan.
Participants will receive intravenous (IV) Etentamig (ABBV-383) at two increasing doses in 21-day cycles.
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, and and monitoring of side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Etentamig Dose A) | Experimental | Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive Etentamig Dose A in 21-day cycles. |
|
| Cohort 2 (Etentamig Dose B) | Experimental | Participants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etentamig | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose-Limiting Toxicities (DLT) | DLT events are defined as adverse events or abnormal laboratory values assessed as "reasonable possibility" of relationship to the administration of Etentamig, which cannot be attributed by the investigator to a clearly identifiable cause such as disease progression or concurrent illness. | Up to Approximately 12 Months |
| Number of Participants with Adverse Events (AE) | AE is defined as 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. | Up to Approximately 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who achieve confirmed partial response (PR) or better determined by International Myeloma Working Group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy. | Up to Approximately 24 Months |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Must have adequate bone marrow function as defined in the protocol.
Must meet laboratory parameters as outlined in the protocol.
Must have a confirmed diagnosis of relapsed/refractory (R/R) 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 International Myeloma Working group (IMWG) criteria.
Must have received at least 3 prior lines of therapy (including exposure to a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 mAb).
Must have measurable disease within 28 days of enrollment, defined as at least 1 of the following:
Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 12 weeks prior to screening and without intervening treatment.
Exclusion Criteria:
- Has received B-cell maturation antigen (BCMA)-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East /ID# 240943 | Kashiwa-shi | Chiba | 277-8577 | Japan | ||
| Hokkaido University Hospital /ID# 242672 |
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PFS is defined as the duration from the date of first dose to the date of disease progression (PD) determined by IMWG criteria, or death, whichever occurs first. |
| Up to Approximately 24 Months |
| Time to Response (TTR) | TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by investigator. | Up to Approximately 24 Months |
| Duration of Response (DOR) | DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented. | Up to Approximately 24 Months |
| Minimal Residual Disease (MRD) Negativity Rate | MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity. | Up to Approximately 24 Months |
| Sapporo |
| Hokkaido |
| 060-8648 |
| Japan |
| Kanazawa University Hospital /ID# 240948 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Duplicate_Okayama Medical Center /ID# 240949 | Okayama | Okayama-ken | 701-1192 | Japan |
| The University of Osaka Hospital /ID# 242032 | Suita-shi | Osaka | 565-0871 | Japan |
| Yamagata University Hospital /ID# 240945 | Yamagata | Yamagata | 990-9585 | 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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