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ACTIVE NOT RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Daratumumab
  • DRUG Pomalidomide
  • DRUG Etentamig

Study Locations (20)

Victoria

  • Monash Health - Monash Medical Centre /ID# 244403 — Clayton
  • St Vincent's Hospital Melbourne /ID# 256879 — Fitzroy Melbourne
  • Peter MacCallum Cancer Ctr /ID# 256880 — Melbourne

Florida

  • Sylvester Comprehensive Cancer Center /ID# 243673 — Miami
  • Moffitt Cancer Center /ID# 243437 — Tampa

Massachusetts

  • Dana-Farber Cancer Institute /ID# 249529 — Boston
  • University of Massachusetts - Worcester /ID# 243977 — Worcester

New York

  • Rutenberg Cancer Center /ID# 244647 — New York
  • Memorial Sloan Kettering Cancer Center /ID# 244656 — New York

New South Wales

  • St George Hospital /ID# 243740 — Kogarah
  • Calvary Mater Newcastle /ID# 243730 — Waratah

Arkansas

  • University of Arkansas for Medical Sciences /ID# 243096 — Little Rock

Maryland

  • University of Maryland, Baltimore /ID# 243679 — Baltimore

Michigan

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438 — Ann Arbor

Trial Details

FieldValue
Enrollment Target 283 participants
Start Date 2022-10-20
Est. Completion 2033-09
Phase Phase 1

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05259839

The ClinicalTrials.gov registry entry for NCT05259839 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05259839 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Victoria, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05259839 about?

NCT05259839 is a clinical study titled "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". 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 ...

What is the current status of trial NCT05259839?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 283 participants. The study started on 2022-10-20. Estimated completion is 2033-09.

What conditions does trial NCT05259839 study?

This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05259839?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Etentamig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05259839?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05259839 being conducted?

This trial has 20 study locations across Arkansas, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial