Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma
Start Date
8/7/2025
Completion Date
3/1/2036
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 adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state 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. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. 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 and monitoring of side effects.
Detailed Description
B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Etentamig
Iberdomide
Conditions
Locations
Beverly Hills Cancer Center /ID# 266921
Beverly Hills, California 90211
United States
Colorado Blood Cancer Institute /ID# 273751
Denver, Colorado 80218
United States
Washington University /ID# 266972
St Louis, Missouri 63110
United States
Rutgers Cancer Institute of New Jersey /ID# 266833
New Brunswick, New Jersey 08901
United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282
New York, New York 10065
United States
University Of North Carolina Health Care - Hillsborough Campus /ID# 278230
Hillsborough, North Carolina 27278
United States
Swedish Medical Center - Seattle /ID# 268052
Seattle, Washington 98104
United States
Blacktown Hospital /ID# 265983
Blacktown, New South Wales 2148
Australia
Wollongong Hospital /ID# 265625
Wollongong, New South Wales 2500
Australia
The Alfred Hospital /ID# 265981
Melbourne, Victoria 3004
Australia
Austin Hospital /ID# 265984
Melbourne, Victoria 3084
Australia
Sir Charles Gairdner Hospital /ID# 265985
Nedlands, Western Australia 6009
Australia
University Health Network_Princess Margaret Cancer Centre /ID# 275636
Toronto, Ontario M5G 2M9
Canada
Jewish General Hospital /ID# 267574
Montreal, Quebec H3T 1E2
Canada
Chu de Nice-Hopital Larchet Ii /Id# 266845
Nice, Alpes-Maritimes 06202
France
Hôpital La Timone /ID# 267053
Marseille, Bouches-du-Rhone 13885
France
Chu De Lille - Hopital Claude Huriez /ID# 270193
Lille, Hauts-de-France 59037
France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694
Tours, Indre-et-Loire 37000
France
IUCT Oncopole /ID# 266391
Toulouse, Occitanie 31059
France
National Cancer Center Hospital East /ID# 268343
Kashiwa-shi, Chiba 277-8577
Japan
Kumamoto University Hospital /ID# 270530
Kumamoto, Kumamoto 860-8556
Japan
Dokkyo Medical University Hospital /ID# 271648
Mibu, Tochigi 321-0293
Japan
Nippon Medical School Hospital /ID# 270254
Bunkyo-ku, Tokyo 113-8603
Japan
The Cancer Institute Hospital Of JFCR /ID# 268342
Koto-ku, Tokyo 135-8550
Japan
Amsterdam UMC, Location VUmc /ID# 267670
Amsterdam, North Holland 1081 HV
Netherlands
Universitair Medisch Centrum Utrecht /ID# 267660
Utrecht, 3584 CX
Netherlands
Oslo Universitetssykehus Ulleval /ID# 275433
Oslo, 0450
Norway