ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-20
Study Completion:2033-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05259839

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
  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.
  3. * Must have measurable disease as determined by central lab as outlined in the protocol.
  4. * Must be naïve to treatment with Etentamig.
  5. * Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
  6. * Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
  7. * Arm E: Participant has received 1-3 prior lines of MM treatment.
  1. * 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.
  2. * 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.
  3. * Has any of the following conditions:
  4. * Nonsecretory Multiple Myeloma (MM).
  5. * Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential.
  6. * Waldenstrom's macroglobulinemia.
  7. * Light chain amyloidosis.
  8. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
  9. * Major surgery within 4 weeks prior to first dose or planned study participation.
  10. * Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
  11. * Uncontrolled diabetes or hypertension within 14 days prior to first dose.
  12. * Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose.

Contacts and Locations

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

University of Arkansas for Medical Sciences /ID# 243096
Little Rock, Arkansas, 72205
United States
Sylvester Comprehensive Cancer Center /ID# 243673
Miami, Florida, 33136-1002
United States
Moffitt Cancer Center /ID# 243437
Tampa, Florida, 33612-9416
United States
University of Maryland, Baltimore /ID# 243679
Baltimore, Maryland, 21201
United States
Dana-Farber Cancer Institute /ID# 249529
Boston, Massachusetts, 02215
United States
University of Massachusetts - Worcester /ID# 243977
Worcester, Massachusetts, 01655
United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
Ann Arbor, Michigan, 48109
United States
The Valley Hospital /ID# 243829
Paramus, New Jersey, 07652
United States
Rutenberg Cancer Center /ID# 244647
New York, New York, 10029-6030
United States
Memorial Sloan Kettering Cancer Center /ID# 244656
New York, New York, 10065-6007
United States
Atrium Health Levine Cancer Institute /ID# 242851
Charlotte, North Carolina, 28204
United States
University of Texas Southwestern Medical Center /ID# 243273
Dallas, Texas, 75390-7208
United States
Huntsman Cancer Institute /ID# 242872
Salt Lake City, Utah, 84112-5500
United States
University of Washington /ID# 243172
Seattle, Washington, 98109
United States
Froedtert Memorial Lutheran Hospital /ID# 242654
Milwaukee, Wisconsin, 53226-3522
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-20
Study Completion Date2033-09

Study Record Updates

Study Start Date2022-10-20
Study Completion Date2033-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Relapsed/Refractory Multiple Myeloma