A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

NCT05259839 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: M22-9472023-506871-88-00
• Study Type: interventional
• Target: 283
• Locations: 7 countries
• Sites: 49

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 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.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

Relapsed/Refractory Multiple Myeloma; Pomalidomide; Dexamethasone; Lenalidomide; Daratumumab; Nirogacestat; Etentamig; ABBV-383; Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig

  DLT events as described in the protocol will be assessed.

  Up to approximately 28 Days

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  Up to Approximately 3 Years

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  Up to Approximately 3 Years

• Progression-Free Survival (PFS)

  Up to Approximately 3 Years

• Duration of Response (DOR)

  Up to Approximately 3 Years

• Time-to-Progression (TTP)

  Up to Approximately 3 Years

• Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)

  Up to Approximately 3 Years

Study Arms (4)

Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)

EXPERIMENTAL

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.

Drug: Etentamig; Drug: Dexamethasone; Drug: Pomalidomide

Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)

EXPERIMENTAL

Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.

Drug: Etentamig; Drug: Dexamethasone; Drug: Lenalidomide

Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)

EXPERIMENTAL

Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.

Drug: Etentamig; Drug: Dexamethasone; Drug: Daratumumab

Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)

EXPERIMENTAL

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.

Drug: Etentamig; Drug: Dexamethasone; Drug: Pomalidomide

Interventions

Etentamig DRUG

Intravenous (IV) Infusion

Also known as: ABBV-383

Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone); Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone); Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone); Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)

Dexamethasone DRUG

Oral; Tablet or IV Infusion

Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone); Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone); Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone); Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)

Lenalidomide DRUG

Oral; Capsule

Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)

Pomalidomide DRUG

Oral; Capsule

Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone); Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)

Daratumumab DRUG

Subcutaneous Injection (SC)

Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
• Unresolved adverse event (AE)s \>= Grade 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from prior anticancer therapy.
• Has any of the following conditions:
• Nonsecretory Multiple Myeloma (MM).
• Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential.
• Waldenstrom's macroglobulinemia.
• Light chain amyloidosis.
• Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
• Major surgery within 4 weeks prior to first dose or planned study participation.
• Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
• Uncontrolled diabetes or hypertension within 14 days prior to first dose.
• Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (49)

University of Arkansas for Medical Sciences /ID# 243096

Little Rock, Arkansas, 72205, United States

Location

Sylvester Comprehensive Cancer Center /ID# 243673

Miami, Florida, 33136-1002, United States

Location

Moffitt Cancer Center /ID# 243437

Tampa, Florida, 33612-9416, United States

Location

University of Maryland, Baltimore /ID# 243679

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute /ID# 249529

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts - Worcester /ID# 243977

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438

Ann Arbor, Michigan, 48109, United States

Location

The Valley Hospital /ID# 243829

Paramus, New Jersey, 07652, United States

Location

Rutenberg Cancer Center /ID# 244647

New York, New York, 10029-6030, United States

Location

Memorial Sloan Kettering Cancer Center /ID# 244656

New York, New York, 10065-6007, United States

Location

Atrium Health Levine Cancer Institute /ID# 242851

Charlotte, North Carolina, 28204, United States

Location

University of Texas Southwestern Medical Center /ID# 243273

Dallas, Texas, 75390-7208, United States

Location

Huntsman Cancer Institute /ID# 242872

Salt Lake City, Utah, 84112-5500, United States

Location

University of Washington /ID# 243172

Seattle, Washington, 98109, United States

Location

Froedtert Memorial Lutheran Hospital /ID# 242654

Milwaukee, Wisconsin, 53226-3522, United States

Location

St George Hospital /ID# 243740

Kogarah, New South Wales, 2217, Australia

Location

Calvary Mater Newcastle /ID# 243730

Waratah, New South Wales, 2298, Australia

Location

Monash Health - Monash Medical Centre /ID# 244403

Clayton, Victoria, 3168, Australia

Location

St Vincent's Hospital Melbourne /ID# 256879

Fitzroy Melbourne, Victoria, 3065, Australia

Location

Peter MacCallum Cancer Ctr /ID# 256880

Melbourne, Victoria, 3000, Australia

Location

Epworth Healthcare /ID# 243734

Richmond, Victoria, 3121, Australia

Location

Fiona Stanley Hospital /ID# 244753

Murdoch, Western Australia, 6150, Australia

Location

Universitaetsklinikum Tuebingen /ID# 242815

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Wuerzburg /ID# 242826

Würzburg, Bavaria, 97080, Germany

Location

Universitaetsklinikum Essen /ID# 242819

Essen, 45147, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf /ID# 243141

Hamburg, 20246, Germany

Location

Universitaetsklinikum Regensburg /ID# 242837

Regensburg, 93042, Germany

Location

IRCCS Ospedale San Raffaele /ID# 242583

Milan, Milano, 20132, Italy

Location

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584

Meldola, Reggio Emilia, 47014, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582

Rome, Roma, 00168, Italy

Location

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 242581

Bologna, 40138, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 244057

Milan, 20122, Italy

Location

Nagoya City University Hospital /ID# 249094

Nagoya, Aichi-ken, 467-8602, Japan

Location

National Cancer Center Hospital East /ID# 245889

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Hokkaido University Hospital /ID# 245966

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanazawa University Hospital /ID# 246812

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Okayama Medical Center /ID# 245882

Okayama, Okayama-ken, 701-1192, Japan

Location

Yamagata University Hospital /ID# 245888

Yamagata, Yamagata, 990-9585, Japan

Location

Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954

Opole, Lower Silesian Voivodeship, 45-372, Poland

Location

Uniwersytecki Szpital Kliniczny We Wrocławiu /ID# 243246

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500

Lublin, Lublin Voivodeship, 20-081, Poland

Location

Uniwersyteckie Centrum Kliniczne /ID# 243249

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Hospital Duran i Reynals /ID# 242979

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 242977

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall de Hebron /ID# 242976

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona /ID# 242978

Barcelona, 08036, Spain

Location

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145

Madrid, 28027, Spain

Location

Hospital Universitario 12 de Octubre /ID# 242975

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 242974

Seville, 41013, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Interventions

Dexamethasone; Lenalidomide; pomalidomide; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2033
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); IT (5); PL (4); DE (5); JP (6); ES (7); AU (7)