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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504674-38-00 | Other Identifier | EU CT |
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Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C & D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C & D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world.
Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.
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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Part 1): ABBV-383 Dose Escalation | Experimental | B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles. |
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| Arm A (Part 2): ABBV-383 Dose Expansion | Experimental | BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles. |
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| Arm B: ABBV-383 BCMA Exposed | Experimental | Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles. |
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| Arm C: ABBV-383 Step Up | Experimental | Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles. |
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| Arm D: ABBV-383 Step Up | Experimental | Participants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etentamig (ABBV-383) | Drug | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events | CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines | Up to Day 28 |
| Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS]) | AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events | CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines | Up to 3 Years |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona /ID# 251405 | Recruiting | Phoenix | Arizona | 85054 | United States | |
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| Highlands Oncology Group - Springdale /ID# 267742 |
| Recruiting |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| Rocky Mountain Cancer Centers - Aurora /ID# 268574 | Recruiting | Aurora | Colorado | 80012 | United States |
| Medical Oncology Hematology Consultants /ID# 268560 | Recruiting | Newark | Delaware | 19713 | United States |
| Hope And Healing Cancer Services /ID# 268536 | Recruiting | Hinsdale | Illinois | 60521 | United States |
| Fort Wayne Medical Oncology And Hematology /ID# 268179 | Recruiting | Fort Wayne | Indiana | 46804 | United States |
| Tulane University School of Medicine /ID# 251204 | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Maryland Oncology Hematology - Silver Spring /ID# 268562 | Not yet recruiting | Silver Spring | Maryland | 20904 | United States |
| Mayo Clinic - Rochester /ID# 251164 | Recruiting | Rochester | Minnesota | 55905-0001 | United States |
| NHO Revive Research Institute, LLC /ID# 267869 | Recruiting | Lincoln | Nebraska | 68506 | United States |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497 | Recruiting | Omaha | Nebraska | 68130 | United States |
| Mt Sinai /ID# 251166 | Recruiting | New York | New York | 10029-6542 | United States |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167 | Recruiting | New York | New York | 10065-6007 | United States |
| University of North Carolina /ID# 251203 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 251165 | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| University Of Cincinnati Medical Center /ID# 251746 | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Willamette Valley Cancer Institute and Research Center /ID# 267088 | Recruiting | Eugene | Oregon | 97401 | United States |
| Baptist Memorial Hospital /ID# 280677 | Not yet recruiting | Memphis | Tennessee | 38120 | United States |
| Vanderbilt Ingram Cancer Center /ID# 252470 | Recruiting | Nashville | Tennessee | 37232-0021 | United States |
| Texas Oncology - Central/South Texas /ID# 268563 | Recruiting | Austin | Texas | 78705 | United States |
| Texas Oncology - Dallas - Worth Street /ID# 280064 | Recruiting | Dallas | Texas | 75246 | United States |
| Oncology Consultants /ID# 268323 | Recruiting | Houston | Texas | 77030 | United States |
| Texas Oncology - Northeast Texas /ID# 268877 | Recruiting | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 268559 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Center. /ID# 267940 | Recruiting | Seattle | Washington | 98109-4405 | United States |
| Northwest Medical Specialties Tacoma /ID# 267117 | Recruiting | Tacoma | Washington | 98405 | United States |
| Juravinski Cancer Centre /ID# 252053 | Recruiting | Hamilton | Ontario | L8V 1C3 | Canada |
| Ottawa Hospital Research Institute /ID# 252151 | Completed | Ottawa | Ontario | K1H 8L6 | Canada |
| Odense University Hospital /ID# 251261 | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
| Vejle Sygehus /ID# 251260 | Recruiting | Vejle | Region Syddanmark | 7100 | Denmark |
| Institut Paoli-Calmettes /ID# 252100 | Completed | Marseille | Bouches-du-Rhone | 13009 | France |
| Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101 | Completed | Créteil | Paris | 94010 | France |
| Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196 | Recruiting | Nantes | Pays de la Loire Region | 44000 | France |
| HCL - Hopital Lyon Sud /ID# 251223 | Recruiting | Pierre-Bénite | Rhone | 69495 | France |
| CHU Poitiers - La miletrie /ID# 251219 | Recruiting | Poitiers | Vienne | 86000 | France |
| AP-HP - Hopital Saint-Antoine /ID# 252326 | Completed | Paris | 75012 | France |
| Rabin Medical Center. /ID# 251330 | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 252079 | Recruiting | Jerusalem | Jerusalem | 91120 | Israel |
| The Chaim Sheba Medical Center /ID# 251329 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 251573 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Hospital Universitario Marques de Valdecilla /ID# 251528 | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545 | Completed | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario de Salamanca /ID# 251529 | Recruiting | Salamanca | 37711 | Spain |
| University College London Hospital /ID# 251357 | Recruiting | London | Greater London | NW1 2BU | United Kingdom |
| The Christie Hospital /ID# 251774 | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| 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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