A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations ETENTAMIG (ABBV-383)

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 8 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 and R. Participants in substudies 5-8 will receive up to two doses of ABBV-2001 or at the dose level(s) established during the escalation phases of ABBV-2001 with iberdomide, mezigdomide, pomalidomide or lenalidomide. Around 602 adult participants with MM will be enrolled at approximately 55 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 SC injections of etentamig at the dose levels established during the escalation phases alone or with DR or K. In substudy 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by SC injections of etentamig at the dose levels established during the escalation phase with Lenalidomide. In substudies 5-8, participants will receive up to two doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide, mezigdomide, pomalidomide or lenalidomide followed by SC injections of ABBV-2001 at the dose level(s) established during the escalation phases with oral iberdomide, mezigdomide, pomalidomide or lenalidomide. 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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participant who has known active central nervous system involvement of MM.
* Participant who has known active infection as outlined in the protocol.

Additional Trial Information

Phase 1/2

Enrollment: 602 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

New York

Weill Cornell

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Open and Accepting

Atrium Health Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Open and Accepting

Oncology Hematology Care, Inc. - Blue Ash

Cincinnati, OH

Open and Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting
Show Arm Statuses
  • Substudy 1: Etentamig Dose Escalation: Active, Not Recruiting
  • Substudy 1: Etentamig Dose Expansion: Active, Not Recruiting
  • Substudy 1: Etentamig Dose Expansion: Active, Not Recruiting
  • Substudy 1: Comparator: Active, Not Recruiting
  • Substudy 2: Etentamig Dose Escalation: Active, Not Recruiting
  • Substudy 2: Etentamig Dose Expansion: Active, Not Recruiting
  • Substudy 2: Etentamig Dose Expansion: Active, Not Recruiting
  • Substudy 2: Comparator: Active, Not Recruiting
  • Substudy 4: Etentamig Dose Escalation: Active, Not Recruiting
  • Substudy 4: Etentamig Dose Expansion: Active, Not Recruiting
  • Substudy 4: Etentamig Dose Expansion: Active, Not Recruiting
  • Substudy 6: ABBV-2001 Dose Escalation: Not Yet Recruiting
  • Substudy 6: ABBV-2001 + Mezigdomide at Combo Dose Level 1: Not Yet Recruiting
  • Substudy 6: ABBV-2001 + Mezigdomide at Combo Dose Level 2: Not Yet Recruiting
  • Substudy 7: ABBV-2001 Dose Escalation: Not Yet Recruiting
  • Substudy 7: ABBV-2001 + Pomalidomide at Combo Dose Level 1: Not Yet Recruiting
  • Substudy 7: ABBV-2001 + Pomalidomide at Combo Dose Level 2: Not Yet Recruiting
  • Substudy 8: ABBV-2001 Dose Escalation: Not Yet Recruiting
  • Substudy 8: ABBV-2001 + Lenalidomide at Combo Dose Level 1: Not Yet Recruiting
  • Substudy 8: ABBV-2001 + Lenalidomide at Combo Dose Level 2: Not Yet Recruiting
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