Multiple Myeloma Clinical Trial

A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

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 and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed.

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. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide.

Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro in 28-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, questionnaires and side effects.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Must have 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 measurable disease as outlined in the protocol.
Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
Has received prior MM treatment in Arms A, B, C, and D.

Exclusion Criteria:

Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment.
Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
Known central nervous system involvement Multiple Myeloma (MM).

Has any of the following conditions:

Nonsecretory MM.
Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
Waldenstrom's macroglobulinemia.
Light chain amyloidosis.
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
Major surgery within 4 weeks prior to first dose or planned study participation.
Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral).
Uncontrolled diabetes or hypertension within 14 days prior to first dose.
Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

270

Study ID:

NCT05259839

Recruitment Status:

Recruiting

Sponsor:

TeneoOne Inc.

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There are 49 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences /ID# 243096
Little Rock Arkansas, 72205, United States
Sylvester Comprehensive Cancer Center /ID# 243673
Miami Florida, 33136, United States
Moffitt Cancer Center /ID# 243437
Tampa Florida, 33612, United States
University of Maryland School of Medicine /ID# 243679
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute /ID# 249529
Boston Massachusetts, 02215, United States More Info
Site Coordinator
Contact
(617) 632-3000
University of Massachusetts - Worcester /ID# 243977
Worcester Massachusetts, 01655, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
Ann Arbor Michigan, 48109, United States
The Valley Hospital /ID# 243829
Paramus New Jersey, 07652, United States
Rutenberg Cancer Center /ID# 244647
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center /ID# 244656
New York New York, 10065, United States
Levine Cancer Institute /ID# 242851
Charlotte North Carolina, 28204, United States
University of Texas Southwestern Medical Center /ID# 243273
Dallas Texas, 75390, United States More Info
Site Coordinator
Contact
214-648-3111
Huntsman Cancer Institute /ID# 242872
Salt Lake City Utah, 84112, United States
University of Washington /ID# 243172
Seattle Washington, 98109, United States
Froedtert Memorial Lutheran Hospital /ID# 242654
Milwaukee Wisconsin, 53226, United States
St George Hospital /ID# 243740
Kogarah New South Wales, 2217, Australia
Calvary Mater Newcastle /ID# 243730
Waratah New South Wales, 2298, Australia
Monash Medical Centre /ID# 244403
Clayton Victoria, 3168, Australia
St Vincent's Hospital Melbourne /ID# 256879
Fitzroy Melbourne Victoria, 3065, Australia
Peter MacCallum Cancer Ctr /ID# 256880
Melbourne Victoria, 3000, Australia
Epworth Healthcare /ID# 243734
Richmond Victoria, 3121, Australia
Fiona Stanley Hospital /ID# 244753
Murdoch Western Australia, 6150, Australia
Universitaetsklinikum Tuebingen /ID# 242815
Tubingen Baden-Wuerttemberg, 72076, Germany
Universitaetsklinikum Essen /ID# 242819
Essen , 45147, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 243141
Hamburg , 20246, Germany
Universitaetsklinikum Regensburg /ID# 242837
Regensburg , 93042, Germany
Universitaetsklinikum Wuerzburg /ID# 242826
Wuerzburg , 97080, Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582
Rome Lazio, 00168, Italy
Ospedale San Raffaele IRCCS /ID# 242583
Milan Milano, 20132, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 242581
Bologna , 40138, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 242584
Meldola , 47014, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057
Milan , 20122, Italy
Nagoya City University Hospital /ID# 249094
Nagoya shi Aichi, 467-8, Japan
National Cancer Center Hospital East /ID# 245889
Kashiwa-shi Chiba, 277-8, Japan
Hokkaido University Hospital /ID# 245966
Sapporo-shi Hokkaido, 060-8, Japan
Kanazawa University Hospital /ID# 246812
Kanazawa-shi Ishikawa, 920-8, Japan
Okayama Medical Center /ID# 245882
Okayama-shi Okayama, 701-1, Japan
Yamagata University Hospital /ID# 245888
Yamagata-shi Yamagata, 990-9, Japan
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954
Opole Dolnoslaskie, 45-37, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocawiu /ID# 243246
Wroclaw Dolnoslaskie, 50-55, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
Lublin Lubelskie, 20-08, Poland
Uniwersyteckie Centrum Kliniczne /ID# 243249
Gdansk Pomorskie, 80-21, Poland
Hospital Duran i Reynals /ID# 242979
Hospitalet de Llobregat Barcelona, 08907, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 242977
Pamplona Navarra, 31008, Spain
Hospital Universitario Vall d'Hebron /ID# 242976
Barcelona , 08035, Spain
Hospital Clinic de Barcelona /ID# 242978
Barcelona , 08036, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145
Madrid , 28027, Spain
Hospital Universitario 12 de Octubre /ID# 242975
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio /ID# 242974
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

270

Study ID:

NCT05259839

Recruitment Status:

Recruiting

Sponsor:


TeneoOne Inc.

How clear is this clinincal trial information?

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