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A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Launched by TENEOONE INC. · Dec 6, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Multiple Myeloma Cancer Abbv 383 B Cell Maturation Antigen

ClinConnect Summary

This clinical trial is studying a new treatment called ABBV-383 for adults with relapsed or refractory multiple myeloma, a type of blood cancer. Multiple myeloma occurs when plasma cells in the blood grow uncontrollably, often causing problems like bone pain and infections. The trial will look at how safe ABBV-383 is and whether it helps improve symptoms in patients whose cancer has returned or hasn’t responded well to previous treatments. About 180 adults will participate, and they will receive the medication as an infusion into a vein over 28-day cycles for up to three years.

To be eligible for the trial, participants must have measurable disease and have already received multiple lines of treatment for their cancer. Depending on the specific group they join in the study, there are different requirements regarding past therapies they must have received. Participants can expect regular hospital visits for assessments, blood tests, and to monitor for any side effects during the trial. It's important to note that this trial might involve a more intensive treatment schedule than standard care, but it aims to explore a promising new option for those with challenging cases of multiple myeloma.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Must have measurable disease as outlined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C only: ECOG performance of \<= 1.
  • 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) 2016 criteria.
  • Must be naïve to treatment with ABBV-383.
  • Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
  • Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
  • Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of ABBV-383.
  • Exclusion Criteria:
  • Arm A: Received BCMA-targeted therapy.
  • Arm C: Rapidly progressing disease per investigator.

Trial Officials

TeneoOne Inc

Study Director

TeneoOne Inc.

About Teneoone Inc.

TeneoOne Inc. is a clinical stage biopharmaceutical company dedicated to advancing innovative therapies for the treatment of cancer. Focused on harnessing the power of the immune system, TeneoOne is committed to developing novel agents that aim to enhance patient outcomes and improve quality of life. With a robust pipeline and a team of experienced professionals, TeneoOne leverages cutting-edge science and strategic collaborations to drive its clinical programs forward, striving to make a meaningful impact in the oncology landscape.

Locations

Phoenix, Arizona, United States

New Orleans, Louisiana, United States

Rochester, Minnesota, United States

New York, New York, United States

New York, New York, United States

Winston Salem, North Carolina, United States

Pierre Benite Cedex, Auvergne Rhone Alpes, France

Ramat Gan, Tel Aviv, Israel

Tel Aviv Yafo, Tel Aviv, Israel

Jerusalem, Yerushalayim, Israel

Petakh Tikva, , Israel

Nottingham, Nottinghamshire, United Kingdom

Manchester, , United Kingdom

Chapel Hill, North Carolina, United States

Cincinnati, Ohio, United States

Nashville, Tennessee, United States

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Odense C, Syddanmark, Denmark

Vejle, Syddanmark, Denmark

Marseille, Bouches Du Rhone, France

Nantes, Pays De La Loire, France

Poitiers, Poitou Charentes, France

Creteil, , France

Paris, , France

Toulouse, , France

Santander, Cantabria, Spain

Majadahonda, Madrid, Spain

Salamanca, , Spain

Norwich, Norfolk, United Kingdom

Edinburgh, , United Kingdom

London, , United Kingdom

Vejle, Syddanmark, Denmark

Poitiers, Vienne, France

Haifa, H Efa, Israel

Tel Aviv, Tel Aviv, Israel

Santander, Cantabria, Spain

Pierre Benite Cedex, Rhone, France

Créteil, , France

New Orleans, Louisiana, United States

Odense, Syddanmark, Denmark

Creteil, Paris, France

Haifa, , Israel

Majadahonda, Madrid, Spain

London, London, City Of, United Kingdom

Tacoma, Washington, United States

Fort Wayne, Indiana, United States

London, Greater London, United Kingdom

Lincoln, Nebraska, United States

Cincinnati, Ohio, United States

Houston, Texas, United States

Hinsdale, Illinois, United States

Austin, Texas, United States

Tyler, Texas, United States

Fairfax, Virginia, United States

Springdale, Arkansas, United States

Newark, Delaware, United States

Aurora, Colorado, United States

Petah Tikva, , Israel

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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