A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Multiple Myeloma

Who is this study for? Patients with relapsed/refractory multiple myeloma
What treatments are being studied? ABBV-383
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
University of Arkansas for Medical Sciences /ID# 243096
RECRUITING
Little Rock
Florida
Sylvester Comprehensive Cancer Center /ID# 243673
RECRUITING
Miami
Moffitt Cancer Center /ID# 243437
RECRUITING
Tampa
Massachusetts
Dana-Farber Cancer Institute /ID# 249529
RECRUITING
Boston
University of Massachusetts - Worcester /ID# 243977
RECRUITING
Worcester
Maryland
University of Maryland, Baltimore /ID# 243679
COMPLETED
Baltimore
Michigan
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
RECRUITING
Ann Arbor
North Carolina
Levine Cancer Institute /ID# 242851
RECRUITING
Charlotte
New Jersey
The Valley Hospital /ID# 243829
RECRUITING
Paramus
New York
Memorial Sloan Kettering Cancer Center /ID# 244656
RECRUITING
New York
Rutenberg Cancer Center /ID# 244647
RECRUITING
New York
Texas
University of Texas Southwestern Medical Center /ID# 243273
RECRUITING
Dallas
Utah
Huntsman Cancer Institute /ID# 242872
RECRUITING
Salt Lake City
Washington
University of Washington /ID# 243172
RECRUITING
Seattle
Wisconsin
Froedtert Memorial Lutheran Hospital /ID# 242654
RECRUITING
Milwaukee
Other Locations
Australia
Monash Health - Monash Medical Centre /ID# 244403
RECRUITING
Clayton
St Vincent's Hospital Melbourne /ID# 256879
RECRUITING
Fitzroy Melbourne
St George Hospital /ID# 243740
RECRUITING
Kogarah
Peter MacCallum Cancer Ctr /ID# 256880
RECRUITING
Melbourne
Fiona Stanley Hospital /ID# 244753
RECRUITING
Murdoch
Epworth Healthcare /ID# 243734
RECRUITING
Richmond
Calvary Mater Newcastle /ID# 243730
RECRUITING
Waratah
Germany
Universitaetsklinikum Essen /ID# 242819
COMPLETED
Essen
Universitaetsklinikum Hamburg-Eppendorf /ID# 243141
RECRUITING
Hamburg
Universitaetsklinikum Regensburg /ID# 242837
RECRUITING
Regensburg
Universitaetsklinikum Tuebingen /ID# 242815
RECRUITING
Tübingen
Universitaetsklinikum Wuerzburg /ID# 242826
RECRUITING
Würzburg
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 242581
RECRUITING
Bologna
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584
RECRUITING
Meldola
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 244057
RECRUITING
Milan
IRCCS Ospedale San Raffaele /ID# 242583
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582
RECRUITING
Rome
Japan
Kanazawa University Hospital /ID# 246812
RECRUITING
Kanazawa
National Cancer Center Hospital East /ID# 245889
RECRUITING
Kashiwa-shi
Nagoya City University Hospital /ID# 249094
RECRUITING
Nagoya
Okayama Medical Center /ID# 245882
RECRUITING
Okayama
Hokkaido University Hospital /ID# 245966
RECRUITING
Sapporo
Yamagata University Hospital /ID# 245888
RECRUITING
Yamagata
Poland
Uniwersyteckie Centrum Kliniczne /ID# 243249
RECRUITING
Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
RECRUITING
Lublin
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954
RECRUITING
Opole
Uniwersytecki Szpital Kliniczny We Wrocławiu /ID# 243246
RECRUITING
Wroclaw
Spain
Hospital Clinic de Barcelona /ID# 242978
RECRUITING
Barcelona
Hospital Universitario Vall de Hebron /ID# 242976
RECRUITING
Barcelona
Hospital Duran i Reynals /ID# 242979
RECRUITING
L'hospitalet De Llobregat
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145
RECRUITING
Madrid
Hospital Universitario 12 de Octubre /ID# 242975
RECRUITING
Madrid
Clinica Universidad de Navarra - Pamplona /ID# 242977
RECRUITING
Pamplona
Hospital Universitario Virgen del Rocio /ID# 242974
RECRUITING
Seville
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2033-09
Participants
Target number of participants: 320
Treatments
Experimental: Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
Experimental: Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
Experimental: Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
Experimental: Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov