Multiple Myeloma Clinical Trials

Find Multiple Myeloma Clinical Trials Near You

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of T Cell Engaging Bi/Tri-specific Antibodies in Subjects With MM

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig and ABBV-2001 in adult participants with MM. Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 6 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants in substudies 1-4 will receive escalating doses of etentamig alone or with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R), followed by etentamig at the dose levels established during the escalation phases alone or with DR, Kd, R. Participants in substudies 1-4 can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Participants in substudies 5-6 will receive escalating doses or at the dose levels established during the escalation phases of ABBV-2001 with iberdomide or mezigdomide. Around 602 adult participants with MM will be enrolled at approximately 75 sites worldwide In substudies 1-3, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or with IV and DRd, DKd, or R. In substudie 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by IV infusions of etentamig at the dose levels established during the escalation phase. In substudies 5-6, participants will receive escalating doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide or mezigdomide, followed by SC injections of ABBV-2001 at the dose levels established during the escalation phases with oral iberdomide or mezigdomide. The study duration is approximately 130 months. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern cooperative oncology group (ECOG) performance of \<= 1.

• Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.

Locations
United States
California
City of Hope National Medical Center /ID# 273132
RECRUITING
Duarte
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911
RECRUITING
Irvine
Colorado
Colorado Blood Cancer Institute /ID# 273129
RECRUITING
Denver
Florida
Moffitt Cancer Center /ID# 272628
RECRUITING
Tampa
Georgia
Winship Cancer Institute of Emory University /ID# 274830
RECRUITING
Atlanta
North Carolina
University of North Carolina at Chapel Hill /ID# 274667
RECRUITING
Chapel Hill
Atrium Health Levine Cancer Institute /ID# 276193
RECRUITING
Charlotte
Atrium Health Wake Forest Baptist Medical Center /ID# 274847
RECRUITING
Winston-salem
New York
Mount Sinai - The Tisch Cancer Institute /ID# 272470
RECRUITING
New York
Weill Cornell Medical College /ID# 272517
RECRUITING
New York
Ohio
Oncology Hematology Care - Blue Ash /ID# 272918
RECRUITING
Cincinnati
The Ohio State University /ID# 271336
RECRUITING
Columbus
Texas
University of Texas - Southwestern Medical Center /ID# 274360
RECRUITING
Dallas
Utah
Huntsman Cancer Institute /ID# 272575
RECRUITING
Salt Lake City
Other Locations
Australia
Royal Adelaide Hospital /ID# 272629
RECRUITING
Adelaide
Coffs Harbour Health Campus /ID# 272010
RECRUITING
Coffs Harbour
St Vincent's Hospital - Melbourne /ID# 276451
RECRUITING
Fitzroy
Peter MacCallum Cancer Centre. /ID# 272024
RECRUITING
Melbourne
Port Macquarie Base Hospital /ID# 275925
RECRUITING
Port Macquarie
Icon Cancer Care - South Brisbane /ID# 271836
RECRUITING
South Brisbane
The Perth Blood Institute - West Perth /ID# 272469
RECRUITING
West Perth
Westmead Hospital /ID# 271880
RECRUITING
Westmead
Israel
Soroka Medical Center /ID# 271367
RECRUITING
Beersheba
Rambam Health Care Campus- Haifa /ID# 271364
RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 271362
RECRUITING
Jerusalem
Rabin Medical Center. /ID# 271365
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 271366
RECRUITING
Ramat Gan
Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 275713
RECRUITING
Kyoto
Nagoya City University Hospital /ID# 273529
RECRUITING
Nagoya
The University of Osaka Hospital /ID# 275791
RECRUITING
Suita-shi
Norway
Oslo Universitetssykehus Ulleval /ID# 277915
RECRUITING
Oslo
United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 274620
RECRUITING
Birmingham
University Hospital of Wales /ID# 273446
RECRUITING
Cardiff
Hammersmith Hospital /ID# 274615
RECRUITING
London
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2035-12
Participants
Target number of participants: 602
Treatments
Experimental: Substudy 1: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.
Experimental: Substudy 1: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Experimental: Substudy 1: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Experimental: Substudy 1: Comparator
Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Escalation
Participants will receive escalating etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Comparator
Participants will receive lenalidomide (R), as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Experimental: Substudy 3: Comparator
Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 5: ABBV-2001 Dose Escalation
Participants will receive escalating ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.
Experimental: Substudy 5: ABBV-2001 Dose Expansion Dose Level 1
Participants will receive dose level 1 of ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.
Experimental: Substudy 5: ABBV-2001 Dose Expansion Dose Level 2
Participants will receive dose level 2 of ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.
Experimental: Substudy 6: ABBV-2001 Dose Escalation
Participants will receive escalating ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.
Experimental: Substudy 6: ABBV-2001 Dose Expansion Dose Level 1
Participants will receive dose level 1 of ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.
Experimental: Substudy 6: ABBV-2001 Dose Expansion Dose Level 2
Participants will receive dose level 2 of ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

Similar Clinical Trials