A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma (NCT05259839) — USA Trial Details

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

EtentamigDexamethasoneLenalidomidePomalidomideDaratumumab

Etentamig: Intravenous (IV) Infusion

Dexamethasone: Oral; Tablet or IV Infusion

Lenalidomide: Oral; Capsule

Pomalidomide: Oral; Capsule

Daratumumab: Subcutaneous Injection (SC)

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

Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Etentamig co-administered with Pd, Rd, or Dd, 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 etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide.

Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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 determined by central lab as outlined in the protocol. * Must be naïve to treatment with Etentamig. * Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded. * Arms A, B and C: Participant has received at least 3 prior lines of MM treatment. * Arm E: Participant has received 1-3 prior lines of MM treatment. 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 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. * Has any of the following conditions: * Nonsecretory Multiple Myeloma (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 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.

Primary outcome measure(s)

Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig — Up to approximately 28 Days
DLT events as described in the protocol will be assessed.
Number of Participants with Adverse Events (AEs) — Up to Approximately 3 Years
An 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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Trial sites (49)

Facility	City	Region
University of Arkansas for Medical Sciences /ID# 243096	Little Rock	Arkansas
Sylvester Comprehensive Cancer Center /ID# 243673	Miami	Florida
Moffitt Cancer Center /ID# 243437	Tampa	Florida
University of Maryland, Baltimore /ID# 243679	Baltimore	Maryland
Dana-Farber Cancer Institute /ID# 249529	Boston	Massachusetts
University of Massachusetts - Worcester /ID# 243977	Worcester	Massachusetts
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438	Ann Arbor	Michigan
The Valley Hospital /ID# 243829	Paramus	New Jersey
Rutenberg Cancer Center /ID# 244647	New York	New York
Memorial Sloan Kettering Cancer Center /ID# 244656	New York	New York
Atrium Health Levine Cancer Institute /ID# 242851	Charlotte	North Carolina
University of Texas - Southwestern Medical Center /ID# 243273	Dallas	Texas
Huntsman Cancer Institute /ID# 242872	Salt Lake City	Utah
University of Washington /ID# 243172	Seattle	Washington
Froedtert Memorial Lutheran Hospital /ID# 242654	Milwaukee	Wisconsin
St George Hospital - Kogarah /ID# 243740	Kogarah	New South Wales
Calvary Mater Newcastle /ID# 243730	Waratah	New South Wales
Monash Health - Monash Medical Centre - Clayton /ID# 244403	Clayton	Victoria
St Vincent's Hospital Melbourne /ID# 256879	Fitzroy Melbourne	Victoria
Peter MacCallum Cancer Ctr /ID# 256880	Melbourne	Victoria
Epworth Healthcare /ID# 243734	Richmond	Victoria
Fiona Stanley Hospital /ID# 244753	Murdoch	Western Australia
Universitaetsklinikum Tuebingen /ID# 242815	Tübingen	Baden-Wurttemberg
Universitaetsklinikum Regensburg /ID# 242837	Regensburg	Bavaria
Universitaetsklinikum Wuerzburg /ID# 242826	Würzburg	Bavaria
Universitaetsklinikum Essen /ID# 242819	Essen	Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 243141	Hamburg	Germany
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584	Meldola	Forlì-Cesena
IRCCS Ospedale San Raffaele /ID# 242583	Milan	Milano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582	Rome	Roma
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 242581	Bologna	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057	Milan	Italy
Nagoya City University Hospital /ID# 249094	Nagoya	Aichi-ken
National Cancer Center Hospital East /ID# 245889	Kashiwa-shi	Chiba
Hokkaido University Hospital /ID# 245966	Sapporo	Hokkaido
Kanazawa University Hospital /ID# 246812	Kanazawa	Ishikawa-ken
Okayama Medical Center /ID# 245882	Okayama	Okayama-ken
Yamagata University Hospital /ID# 245888	Yamagata	Yamagata
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954	Opole	Lower Silesian Voivodeship
Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 243246	Wroclaw	Lower Silesian Voivodeship

+ 9 more sites — see the full list on the official registry below.

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