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

Last updated: March 3, 2025
Sponsor: TeneoOne Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Leukemia

Platelet Disorders

Treatment

Nirogacestat

ABBV-383

Lenalidomide

Clinical Study ID

NCT05259839
M22-947
2023-506871-88-00
2021-005587-22
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 lasttreatment regimen based on the investigator's determination of the InternationalMyeloma Working Group (IMWG) criteria.

  • Must have measurable disease as determined by central lab as outlined in theprotocol.

  • Must be naïve to treatment with Etentamig.

  • Must have never received BCMA-targeted therapy. Participants who have receivedtargeted 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

Exclusion Criteria:

  • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or anallogeneic SCT within 1 year of the first dose of study treatment.

  • Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] CommonTerminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancertherapy.

  • 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 skinchanges (POEMS) syndrome.

  • Major surgery within 4 weeks prior to first dose or planned studyparticipation.

  • 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 priorto first dose.

Study Design

Total Participants: 320
Treatment Group(s): 7
Primary Treatment: Nirogacestat
Phase: 1
Study Start date:
October 20, 2022
Estimated Completion Date:
September 30, 2033

Connect with a study center

  • St George Hospital /ID# 243740

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle /ID# 243730

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 244403

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 244403

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne /ID# 256879

    Fitzroy Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 244403

    Melbourne, Victoria 3168
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Ctr /ID# 256880

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Epworth Healthcare /ID# 243734

    Richmond, Victoria 3121
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital /ID# 244753

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Universitaetsklinikum Tuebingen /ID# 242815

    Tubingen, Baden-Wuerttemberg 72076
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg /ID# 242826

    Wuerzburg, Bayern 97080
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen /ID# 242819

    Essen, 45147
    Germany

    Completed

  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 243141

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 243141

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitaetsklinikum Regensburg /ID# 242837

    Regensburg, 93042
    Germany

    Active - Recruiting

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 242581

    Bologna, Emilia-Romagna 40138
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582

    Rome, Lazio 00168
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele /ID# 242583

    Milan, Milano 20132
    Italy

    Active - Recruiting

  • Ospedale San Raffaele IRCCS /ID# 242583

    Milan, Milano 20132
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584

    Meldola, Reggio Emilia 47014
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582

    Rome, Roma 00168
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 242581

    Bologna, 40138
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 242584

    Meldola, 47014
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057

    Milan, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 244057

    Milano, 20122
    Italy

    Active - Recruiting

  • Nagoya City University Hospital /ID# 249094

    Nagoya shi, Aichi 467-8602
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East /ID# 245889

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • Hokkaido University Hospital /ID# 245966

    Sapporo-shi, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Kanazawa University Hospital /ID# 246812

    Kanazawa-shi, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Okayama Medical Center /ID# 245882

    Okayama-shi, Okayama 701-1192
    Japan

    Active - Recruiting

  • Yamagata University Hospital /ID# 245888

    Yamagata-shi, Yamagata 990-9585
    Japan

    Active - Recruiting

  • Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954

    Opole, Dolnoslaskie 45-372
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroc?awiu /ID# 243246

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocawiu /ID# 243246

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu /ID# 243246

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 243246

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 243500

    Lublin, Lubelskie 20-081
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500

    Lublin, Lubelskie 20-081
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne /ID# 243249

    Gdansk, Pomorskie 80-214
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice /ID# 243247

    Katowice, 40-519
    Poland

    Site Not Available

  • Hospital Duran i Reynals /ID# 242979

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 242977

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 242977

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona /ID# 242978

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron /ID# 242976

    Barcelona, 08035
    Spain

    Active - Recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre /ID# 242975

    Madrid, 28041
    Spain

    Active - Recruiting

  • Duplicate_Hospital Universitario Virgen del Rocio /ID# 242974

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 242974

    Sevilla, 41013
    Spain

    Active - Recruiting

  • University of Arkansas for Medical Sciences /ID# 243096

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center /ID# 243673

    Miami, Florida 33136-1002
    United States

    Active - Recruiting

  • Moffitt Cancer Center /ID# 243437

    Tampa, Florida 33612-9416
    United States

    Active - Recruiting

  • University of Maryland Medical Center /ID# 243679

    Baltimore, Maryland 21201
    United States

    Completed

  • University of Maryland School of Medicine /ID# 243679

    Baltimore, Maryland 21201-1544
    United States

    Active - Recruiting

  • University of Maryland, Baltimore /ID# 243679

    Baltimore, Maryland 21201
    United States

    Completed

  • Dana-Farber Cancer Institute /ID# 249529

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • University of Massachusetts - Worcester /ID# 243977

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Bozeman Health Cancer Center /ID# 243830

    Bozeman, Montana 59715
    United States

    Site Not Available

  • The Valley Hospital /ID# 243829

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center /ID# 244656

    New York, New York 10065-6007
    United States

    Active - Recruiting

  • Rutenberg Cancer Center /ID# 244647

    New York, New York 10029-6030
    United States

    Active - Recruiting

  • Levine Cancer Institute /ID# 242851

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Levine Cancer Institute, Atrium Health /ID# 242851

    Charlotte, North Carolina 28204-2812
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center /ID# 243273

    Dallas, Texas 75390-7208
    United States

    Active - Recruiting

  • Huntsman Cancer Institute /ID# 242872

    Salt Lake City, Utah 84112-5500
    United States

    Active - Recruiting

  • University of Washington /ID# 243172

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Froedtert Memorial Lutheran Hospital /ID# 242654

    Milwaukee, Wisconsin 53226-3522
    United States

    Active - Recruiting

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