Phase
Condition
Multiple Myeloma
Leukemia
Platelet Disorders
Treatment
Nirogacestat
ABBV-383
Lenalidomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
St George Hospital /ID# 243740
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
Calvary Mater Newcastle /ID# 243730
Waratah, New South Wales 2298
AustraliaActive - Recruiting
Monash Health - Monash Medical Centre /ID# 244403
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Medical Centre /ID# 244403
Clayton, Victoria 3168
AustraliaActive - Recruiting
St Vincent's Hospital Melbourne /ID# 256879
Fitzroy Melbourne, Victoria 3065
AustraliaActive - Recruiting
Monash Medical Centre /ID# 244403
Melbourne, Victoria 3168
AustraliaActive - Recruiting
Peter MacCallum Cancer Ctr /ID# 256880
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Epworth Healthcare /ID# 243734
Richmond, Victoria 3121
AustraliaActive - Recruiting
Fiona Stanley Hospital /ID# 244753
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Universitaetsklinikum Tuebingen /ID# 242815
Tubingen, Baden-Wuerttemberg 72076
GermanyActive - Recruiting
Universitaetsklinikum Wuerzburg /ID# 242826
Wuerzburg, Bayern 97080
GermanyActive - Recruiting
Universitaetsklinikum Essen /ID# 242819
Essen, 45147
GermanyCompleted
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 243141
Hamburg, 20246
GermanyActive - Recruiting
Universitaetsklinikum Hamburg-Eppendorf /ID# 243141
Hamburg, 20246
GermanyActive - Recruiting
Universitaetsklinikum Regensburg /ID# 242837
Regensburg, 93042
GermanyActive - Recruiting
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 242581
Bologna, Emilia-Romagna 40138
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582
Rome, Lazio 00168
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele /ID# 242583
Milan, Milano 20132
ItalyActive - Recruiting
Ospedale San Raffaele IRCCS /ID# 242583
Milan, Milano 20132
ItalyActive - Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584
Meldola, Reggio Emilia 47014
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582
Rome, Roma 00168
ItalyActive - Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 242581
Bologna, 40138
ItalyActive - Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 242584
Meldola, 47014
ItalyActive - Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057
Milan, 20122
ItalyActive - Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 244057
Milano, 20122
ItalyActive - Recruiting
Nagoya City University Hospital /ID# 249094
Nagoya shi, Aichi 467-8602
JapanActive - Recruiting
National Cancer Center Hospital East /ID# 245889
Kashiwa-shi, Chiba 277-8577
JapanActive - Recruiting
Hokkaido University Hospital /ID# 245966
Sapporo-shi, Hokkaido 060-8648
JapanActive - Recruiting
Kanazawa University Hospital /ID# 246812
Kanazawa-shi, Ishikawa 920-8641
JapanActive - Recruiting
Okayama Medical Center /ID# 245882
Okayama-shi, Okayama 701-1192
JapanActive - Recruiting
Yamagata University Hospital /ID# 245888
Yamagata-shi, Yamagata 990-9585
JapanActive - Recruiting
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954
Opole, Dolnoslaskie 45-372
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroc?awiu /ID# 243246
Wroclaw, Dolnoslaskie 50-556
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocawiu /ID# 243246
Wroclaw, Dolnoslaskie 50-556
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu /ID# 243246
Wroclaw, Dolnoslaskie 50-556
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 243246
Wroclaw, Dolnoslaskie 50-556
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
Lublin, Lubelskie 20-081
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
Lublin, Lubelskie 20-081
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne /ID# 243249
Gdansk, Pomorskie 80-214
PolandActive - Recruiting
Pratia Onkologia Katowice /ID# 243247
Katowice, 40-519
PolandSite Not Available
Hospital Duran i Reynals /ID# 242979
Hospitalet de Llobregat, Barcelona 08907
SpainActive - Recruiting
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 242977
Pamplona, Navarra 31008
SpainActive - Recruiting
Clinica Universidad de Navarra - Pamplona /ID# 242977
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Clinic de Barcelona /ID# 242978
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron /ID# 242976
Barcelona, 08035
SpainActive - Recruiting
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145
Madrid, 28027
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 242975
Madrid, 28041
SpainActive - Recruiting
Duplicate_Hospital Universitario Virgen del Rocio /ID# 242974
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio /ID# 242974
Sevilla, 41013
SpainActive - Recruiting
University of Arkansas for Medical Sciences /ID# 243096
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Sylvester Comprehensive Cancer Center /ID# 243673
Miami, Florida 33136-1002
United StatesActive - Recruiting
Moffitt Cancer Center /ID# 243437
Tampa, Florida 33612-9416
United StatesActive - Recruiting
University of Maryland Medical Center /ID# 243679
Baltimore, Maryland 21201
United StatesCompleted
University of Maryland School of Medicine /ID# 243679
Baltimore, Maryland 21201-1544
United StatesActive - Recruiting
University of Maryland, Baltimore /ID# 243679
Baltimore, Maryland 21201
United StatesCompleted
Dana-Farber Cancer Institute /ID# 249529
Boston, Massachusetts 02215
United StatesActive - Recruiting
University of Massachusetts - Worcester /ID# 243977
Worcester, Massachusetts 01655
United StatesActive - Recruiting
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Bozeman Health Cancer Center /ID# 243830
Bozeman, Montana 59715
United StatesSite Not Available
The Valley Hospital /ID# 243829
Paramus, New Jersey 07652
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center /ID# 244656
New York, New York 10065-6007
United StatesActive - Recruiting
Rutenberg Cancer Center /ID# 244647
New York, New York 10029-6030
United StatesActive - Recruiting
Levine Cancer Institute /ID# 242851
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Levine Cancer Institute, Atrium Health /ID# 242851
Charlotte, North Carolina 28204-2812
United StatesActive - Recruiting
University of Texas Southwestern Medical Center /ID# 243273
Dallas, Texas 75390-7208
United StatesActive - Recruiting
Huntsman Cancer Institute /ID# 242872
Salt Lake City, Utah 84112-5500
United StatesActive - Recruiting
University of Washington /ID# 243172
Seattle, Washington 98109
United StatesActive - Recruiting
Froedtert Memorial Lutheran Hospital /ID# 242654
Milwaukee, Wisconsin 53226-3522
United StatesActive - Recruiting
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