Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Japan / NCT06223516
Active, not recruiting Phase 1

Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

NCT06223516 · tracked via the Priya Life Science Japan tracker
Sponsor
AbbVie
Phase
Phase 1
Started
2024-06-17
Last updated
2026-03-27

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Subcutaneous (SC) Etentamig →Intravenous (IV) Etentamig →

Subcutaneous (SC) Etentamig: SC Injection

Intravenous (IV) Etentamig: IV Infusion

Study summary

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 and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.

Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world

In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug. * Must be naïve to treatment with ABBV-383. Exclusion Criteria: \- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Primary outcome measure(s)

  • Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events — Up to 2 cycles (56 days)
    Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
  • Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events — Up to 2 cycles (56 days)
    ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
  • Maximum Observed Concentration (Cmax) of ABBV-383 — Up to 32 weeks
    Cmax of ABBV-383.
  • Time to Cmax (Tmax) of ABBV-383 — Up to 32 weeks
    Tmax of ABBV-383.
  • Trough Concentration (Ctrough) of ABBV-383 — Up to 32 weeks
    Ctrough of ABBV-383.
  • Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383 — Up to 24 weeks
    AUC of ABBV-383.

Trial sites (15)

FacilityCityRegionStatus
Mayo Clinic Arizona /ID# 260799 Phoenix Arizona
Mayo Clinic Hospital Jacksonville /ID# 262808 Jacksonville Florida
Sylvester Comprehensive Cancer Center /ID# 260798 Miami Florida
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050 Ann Arbor Michigan
Mayo Clinic - Rochester /ID# 262807 Rochester Minnesota
Atrium Health Wake Forest Baptist Medical Center /ID# 260807 Winston-Salem North Carolina
Wisconsin Medical Center /ID# 261085 Milwaukee Wisconsin
Universitaetsklinikum Frankfurt /ID# 260442 Frankfurt am Main Hesse
Universitaetsklinikum Koeln /ID# 260445 Cologne North Rhine-Westphalia
Universitaetsklinikum Hamburg-Eppendorf /ID# 260444 Hamburg Germany
Hadassah Medical Center-Hebrew University /ID# 261446 Jerusalem Jerusalem
The Chaim Sheba Medical Center /ID# 261699 Ramat Gan Tel Aviv
Tel Aviv Sourasky Medical Center /ID# 261525 Tel Aviv Tel Aviv
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286 Nagoya Aichi-ken
Kindai University Hospital /ID# 266016 Sakai-shi Osaka

More AbbVie trials in Japan

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer Recruiting
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Recruiting
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) Active, not recruiting
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan Recruiting
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. Active, not recruiting

Other trials for the same condition

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting
A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM) Recruiting
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06223516 on ClinicalTrials.gov ↗ ← All trials in Japan