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NCT06896916 | RECRUITING | Multiple Myeloma


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
Sponsor:

AbbVie

Brief 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.

Condition or disease

Multiple Myeloma

Intervention/treatment

Etentamig

Iberdomide

Phase

PHASE1

Detailed Description:

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

Study Type : INTERVENTIONAL
Estimated Enrollment : 135 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : 2025-08-07
Estimated Primary Completion Date : 2036-03
Estimated Study Completion Date : 2036-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1.
  • * Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
  • * All participants must have measurable diseases per central laboratory as outlined in protocol
Exclusion Criteria
  • * Has received prior etentamig treatment.
  • * Prior exposure to BCMA-targeted therapy as noted in the protocol.
  • * Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).

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

Location Details

NCT06896916


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, California

Beverly Hills Cancer Center /ID# 266921

Beverly Hills, California, United States, 90211

RECRUITING

United States, Colorado

Colorado Blood Cancer Institute /ID# 273751

Denver, Colorado, United States, 80218

RECRUITING

United States, Missouri

Washington University /ID# 266972

St Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey /ID# 266833

New Brunswick, New Jersey, United States, 08901

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

University Of North Carolina Health Care - Hillsborough Campus /ID# 278230

Hillsborough, North Carolina, United States, 27278

RECRUITING

United States, Washington

Swedish Medical Center - Seattle /ID# 268052

Seattle, Washington, United States, 98104

RECRUITING

Australia, New South Wales

Blacktown Hospital /ID# 265983

Blacktown, New South Wales, Australia, 2148

RECRUITING

Australia, New South Wales

Wollongong Hospital /ID# 265625

Wollongong, New South Wales, Australia, 2500

RECRUITING

Australia, Victoria

The Alfred Hospital /ID# 265981

Melbourne, Victoria, Australia, 3004

RECRUITING

Australia, Victoria

Austin Hospital /ID# 265984

Melbourne, Victoria, Australia, 3084

RECRUITING

Australia, Western Australia

Sir Charles Gairdner Hospital /ID# 265985

Nedlands, Western Australia, Australia, 6009

RECRUITING

Canada, Ontario

University Health Network_Princess Margaret Cancer Centre /ID# 275636

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

Jewish General Hospital /ID# 267574

Montreal, Quebec, Canada, H3T 1E2

RECRUITING

France, Alpes-Maritimes

Chu de Nice-Hopital Larchet Ii /Id# 266845

Nice, Alpes-Maritimes, France, 06202

RECRUITING

France, Bouches-du-Rhone

La Timone Hospital /ID# 267053

Marseille, Bouches-du-Rhone, France, 13885

RECRUITING

France, Hauts-de-France

Chu De Lille - Hopital Claude Huriez /ID# 270193

Lille, Hauts-de-France, France, 59037

RECRUITING

France, Indre-et-Loire

Tours Regional University Hospital - Bretonneau Hospital /ID# 267694

Tours, Indre-et-Loire, France, 37000

RECRUITING

France, Occitanie

IUCT Oncopole /ID# 266391

Toulouse, Occitanie, France, 31059

RECRUITING

Japan, Kumamoto

Kumamoto University Hospital /ID# 270530

Kumamoto, Kumamoto, Japan, 860-8556

RECRUITING

Japan, Tochigi

Dokkyo Medical University Hospital /ID# 271648

Years, Tochigi, Japan, 321-0293

RECRUITING

Japan, Tokyo

Nippon Medical School Hospital /ID# 270254

Bunkyo Ward, Tokyo, Japan, 113-8603

RECRUITING

Japan, Tokyo

The Cancer Institute Hospital Of JFCR /ID# 268342

This talk, Tokyo, Japan, 135-8550

RECRUITING

Netherlands, North Holland

Amsterdam UMC, Location VUmc /ID# 267670

Amsterdam, North Holland, Netherlands, 1081 HV

RECRUITING

Netherlands,

University Medical Center Utrecht /ID# 267660

Utrecht, Netherlands, 3584 CX

RECRUITING

Norway,

Oslo University Hospital Ulleval /ID# 275433

Oslo, Norway, 0450

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