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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Multiple Myeloma

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

Condition
Relapsed/Refractory Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas for Medical Sciences /ID# 243096, Little Rock, Arkansas, United States, 72205

Miami

Sylvester Comprehensive Cancer Center /ID# 243673, Miami, Florida, United States, 33136-1002

Tampa

Moffitt Cancer Center /ID# 243437, Tampa, Florida, United States, 33612-9416

Baltimore

University of Maryland, Baltimore /ID# 243679, Baltimore, Maryland, United States, 21201

Boston

Dana-Farber Cancer Institute /ID# 249529, Boston, Massachusetts, United States, 02215

Worcester

University of Massachusetts - Worcester /ID# 243977, Worcester, Massachusetts, United States, 01655

Ann Arbor

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438, Ann Arbor, Michigan, United States, 48109

Paramus

The Valley Hospital /ID# 243829, Paramus, New Jersey, United States, 07652

New York

Rutenberg Cancer Center /ID# 244647, New York, New York, United States, 10029-6030

New York

Memorial Sloan Kettering Cancer Center /ID# 244656, New York, New York, United States, 10065-6007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TeneoOne Inc.,

TeneoOne Inc, STUDY_DIRECTOR, TeneoOne Inc.

Study Record Dates

2033-09